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SK pharmteco’s subsidiary Yposkesi launches AAVelocity, a plug-and-play Adeno-Associated Virus (AAV) platform

November 7, 2023

Designed to shorten turnaround on manufacturing AAVs, this new platform offers Cell and Gene Therapy developers more flexibility in producing viral vectors for clinical and commercial use

Yposkesi, SK pharmteco’s European clinical and commercial viral vector manufacturing subsidiary for Cell and Gene Therapies (C&GT), today launches AAVelocityTM, a plug-and-play Adeno-Associated Virus (AAV) platform. AAVelocity is designed to bring cost and time efficiencies to drug developers in the production of AAV gene delivery systems used to transport gene therapy into tissue to prevent, treat, or cure inherited disorders and rare diseases.


The AAVelocity plug-and-play platform can provide a 12-month turnaround on drug developer projects, lowering industry average standard bioprocessing timeframes by at least six months and helping clients save on associated costs.


Also new is AAVelocity’s inherent flexibility. This enables bioproduction teams to easily adapt to client requirements, such as achieving different purity levels within strict time constraints. It includes delivering AAVs containing the optimized amount of genetic material.

AAVelocity’s agility also avoids intermediary steps or the addition of others while ensuring total integrity and purity of the genetic material. The improved efficacy of AAVelocity will bring greater benefits to drug developers and their pipelines, according to SK pharmteco. Using single-use bioreactors, the AAV platform is scalable to meet any client need: 10L > 50L > 200L > 2 x 200L > 1000L.

“SK pharmteco, through Yposkesi, is pleased to launch a second platform for viral vector manufacturing with enhanced plug-and-play capabilities. Leveraging Yposkesi’s many years of expertise, SK pharmteco is able to offer a genuine cost and time-effective solution for AAV manufacturing to stay in step with the increasing development and approvals of C&GT treatments we are witnessing today, which are set to evolve in the near future,” said Alain Lamproye, Yposkesi division head. “AAVelocity will bring tangible benefits to the C&GT market: high yields, scalability, robustness, consistency, and flexibility like no other. Clients can also benefit considerably from Yposkesi’s strong track record in AAV manufacturing and its experience of participating in filing six IND1/IMPD of AAV-based products since 2017.”

The strengthening of AAV manufacturing at its subsidiary aligns with SK pharmteco’s positioning to meet the growing demand.

According to the Nice Insight report ‘Cell and Gene Therapy: 2023 Market Analysis, CDMO Pricing, and Benchmarking’: “AAV-based therapies are set for greater approval number and approval of treatments for more prevalent diseases,” making it the most represented viral vector within those therapies starting in 2025. By 2028: “Sales of AAV-associated cell and gene therapies are projected to be 72% higher than LV-based therapies.”

AAVelocity key features:

  • -High yields: 3×1010 VG/mL up to 2×1011 VG/mL
  • -Scalable from 250ml for R&D, up to 1,000L for cGMP batches
  • -Robustness: No loss of titer when scaling up
  • -Enriched: >80% full particles

Further capabilities, including plasmid manufacturing, process development, GMP vector manufacturing suites, integrated testing & analytics, regulatory services, and an adherent AAV manufacturing platform, are available at the Center for Breakthrough Medicines (CBM), SK pharmteco’s US clinical and commercial viral vector manufacturing subsidiary for C&GT.

1 Investigational New Drug/Investigational Medicinal Product Dossier

About Yposkesi

Yposkesi is SK pharmteco’s European clinical and commercial viral vector manufacturing subsidiary for Cell and Gene Therapies (C&GT). Located in the south of Paris, France, Yposkesi is one of Europe’s largest CDMOs for viral vector manufacturing in Cell and Gene Therapies.


Now unified with the Center for Breakthrough Medicines (CBM) in the Philadelphia region, USA, Yposkesi and CBM offer a full range of services throughout the entire advanced therapy process, from research and development to manufacturing and commercialization. With locations in Europe and the US, together they operate multiple manufacturing suites for bulk drug substances and fill and finish to support the growing demand for late-phase projects.
www.yposkesi.com

About Center for Breakthrough Medicines

Center for Breakthrough Medicines (CBM) is a purpose-built and patient-driven, cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, and manufacture life-saving therapies on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM is the U.S. headquarters for SK pharmteco Cell & Gene, which is comprised of CBM and Paris-based Yposkesi, a viral vector CDMO, who together have assembled the most accomplished experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, end-to-end, best-in-class services to provide life-changing – and life-saving – therapies around the world.

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Contact:
Andrew Lloyd & Associates
Carol Leslie / Juliette Schmitt
carol@ala.associates / juliette@ala.associates
UK and US: +44 1273 952 481
@ALA_Group

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SK pharmteco to Expand Capabilities with Acquisition of Controlling Interest in Center for Breakthrough Medicines

September 20, 2023

FOR IMMEDIATE RELEASE

  • – CBM brings extensive cell and gene therapy expertise to SK pharmteco portfolio and continues SK pharmteco’s strategy to deliver end-to-end, multi-modality support for clients

  • – SK pharmteco previously invested $350 million in CBM in 2022

RANCHO CORDOVA, Ca. & KING OF PRUSSIA, Pa. (Sept. 20, 2023)SK pharmteco continues its trajectory to become the leading multi-modality CDMO by announcing it is acquiring a controlling interest in Philadelphia-based cell and gene therapy CDMO Center for Breakthrough Medicines (CBM), a move that will expand SK pharmteco’s technical expertise, production capacity, and geographic reach.

Today’s announcement is less than two years after an initial $350 million capital investment in 2022 and comes on the heels of SK pharmteco’s acquisition of Yposkesi, a French viral vector CDMO, in March 2021. SK pharmteco will have a controlling stake in CBM, and the operations of CBM will be integrated with Yposkesi to establish a global CGT business unit with unprecedented capabilities and capacity.

“With CGT manufacturing sites in both Europe and the U.S., SK pharmteco is closer to its goal of being a leading CDMO that produces both chemical APIs and biologic drugs,” said Joerg Ahlgrimm, CEO of SK pharmteco. “As we continue our journey from being a leader in small molecule development and manufacturing to being a leader in multiple modalities, including CGT, we will ensure our focus remains on our unwavering dedication to providing lifesaving therapies to patients around the world and bringing solutions to our clients.”

SK pharmteco will have end-to-end cell and gene therapy offerings in both the U.S. and Europe, providing comprehensive services and expertise, including process development, plasmid DNA production, viral vector manufacturing, cell therapy processing, and fully integrated testing and analytics.

Additionally, SK pharmteco will continue to invest in building one of the largest CGT CDMOs in terms of capacity and capabilities, with a focus on emerging technologies and new approaches to complement the existing platforms offered to its clients in both adherent and suspension processes.

“The Center for Breakthrough Medicines team is truly excited to join the SK pharmteco family, a global leader in the CDMO industry,” said Audrey Greenberg, co-founder and chief business officer of CBM. “Working together with Yposkesi, AMPAC fine chemical, and SK Biotek, we are very well positioned to work with our clients in saving millions of lives around the world.”

SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate, and has 13 offices and manufacturing facilities across the U.S., Europe, and Korea, all with a combined vision to provide life-changing and lifesaving therapies to more than 200 million patients by 2026.

About SK pharmteco

Headquartered in Rancho Cordova, Calif., SK pharmteco is a global contract development and manufacturing organization specializing in the production of active pharmaceutical ingredients (APIs), advanced intermediates, and cell and gene therapy for the pharmaceutical industry. SK pharmteco is comprised of six business units: SK Biotek Korea, SK Biotek Ireland, AMPAC Fine Chemicals, AMPAC Analytical Laboratories in the U.S., Yposkesi and the Center for Breakthrough Medicines. SK pharmteco is owned by SK Inc., the strategic investment arm of South Korea’s SK Group. For more on SK pharmteco, visit skpharmteco.com. For more on SK, visit sk.com.

About The Center for Breakthrough Medicines

Center for Breakthrough Medicines (CBM) is a purpose-built and patient-driven, cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, and manufacture life-saving therapies on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM is the U.S. headquarters for SK pharmteco Cell & Gene, which is comprised of CBM and Paris-based Yposkesi, a viral vector CDMO, who together have assembled the most accomplished experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, end-to-end, best-in-class services to provide life-changing – and life-saving – therapies around the world.

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Contact:
Center for Breakthrough Medicines
Keith Bowermaster, APR, CCMP
keith@modiggroup.com
Website: www.skpharmteco.com
SOURCE: SK pharmteco

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Center for Breakthrough Medicines Now Provides a Clinically Tested Adherent Manufacturing Platform for AAV Production

April 12, 2023

CBM is the Exclusive CDMO Provider of an iCellis 500-based Adeno-Associated Virus (AAV) Adherent Platform developed by the Gene Therapy Program at the University of Pennsylvania

King of Prussia, PA — April 11, 2023The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing critical challenges associated with the commercialization of cell and gene therapies, has completed a successful technology transfer of the University of Pennsylvania Gene Therapy Program’s (GTP) adherent cell manufacturing platform for producing Adeno-Associated Virus (AAV) gene therapies. As GTP’s exclusive CDMO partner, CBM clients will have immediate access to the adherent platform for AAV vector manufacturing, enabling rapid acceleration of AAV assets from discovery to the clinic.

Comprehensive and scalable, the GTP-developed platform has been well characterized and can be used to quickly manufacture high-quality advanced AAV gene therapies. The manufacturing platform has been used to manufacture 100 successful production scale batches and production runs for four clinical phase programs. With limited process development required and materials ready to go, the manufacturing platform may enable clinical candidate selection to Tox in as little as four months and clinical candidate selection to GMP in as little as six months.

In addition, the GTP-developed platform helps to accelerate development via advanced assays and analytics, onsite testing, reduced sample requirements, and reduced testing turn-around times. The platform’s manufacturing process is applicable across multiple AAV serotypes and genes of therapeutic product development interest. Additionally, its downstream process has an average recovery of 30% and results in greater than 80% full capsids by analytical ultracentrifuge analysis and can pool up to three upstream runs into a single downstream harvest with a typical yield of 4.8E16 total GC at harvest.

“As the exclusive CDMO provider of the GTP-developed platform, CBM is able to provide its clients the option of a well-characterized adherent AAV platform to advance their programs from discovery to first-in-human studies safely and rapidly, with less risk and expense,” said Jennifer Manning, SVP of Global Strategic Partnerships at CBM. “The platform, combined with CBM’s manufacturing expertise and state-of-the-art, high throughput cGMP suites, as well as on-site experts , provides innovator companies the critical elements required to efficiently translate lifesaving therapies from bench to bedside.”

About The Center for Breakthrough Medicines (CBM)

Center for Breakthrough Medicines (CBM) is a purpose-built and patient-driven, cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, and manufacture life-saving therapies on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, end-to-end, best-in-class services from pre-clinical through commercial, including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.

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For more information, contact:
Center for Breakthrough Medicines
Keith Bowermaster, APR, CCMP
CBM@CoynePR.com

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Cell One Partners and Center for Breakthrough Medicines Announce Strategic Partnership to Accelerate Cell and Gene Therapy Commercialization

March 9, 2023

NEW YORK, March 9, 2023 — Cell One Partners Inc., an industry-leading strategic consulting firm positioned to support cell and gene therapy (CGT) companies with scientific and commercial expertise to guide their research from laboratory to commercialization, and King of Prussia-based Center for Breakthrough Medicines (CBM), a cell and gene therapy contract development and manufacturing organization (CDMO), today announced a strategic partnership to accelerate the development and commercialization of cell and gene therapies.

Cell One Partners provides its clients with virtual company creation and management for all aspects of drug development and commercialization. This partnership combines Cell One Partners’ strategic vision of enabling new company formation through virtual executive leadership and program management to accelerate assets from the bench to the clinic and finally to market with CBM’s commitment to providing industry-leading technologies, capabilities, and massive capacity for end-to-end development, testing, and manufacturing of lifesaving therapies.

“Our unique model of creating and managing virtual companies for CGT asset owners allows them to accelerate their pathway to commercialization via our unparalleled network of cell and gene therapy leaders and innovators to support all aspects of the development, manufacturing, and commercialization continuum at about one-third of the management cost of setting up a traditional company with C-level executives,” said George S. Goldberger, Founder and Chief Executive Officer of Cell One Partners. “The Center for Breakthrough Medicines is a valuable asset to our clients as their integrated, end-to-end services, all located in a single complex, allow innovator companies to optimize their working capital and focus on driving the science toward commercialization.”

A barrier for many early-stage CGT development companies, including those tied to academic institutions, is a lack of access to senior C-suite leadership who can provide counsel and guidance on all aspects of getting a therapy from idea to clinic, including clinical development planning, product pipeline assessment, management and organizational development, and regulatory and approval pathway development. Cell One Partners’ unique, virtual company creation removes those barriers by providing virtual, world-class management at typically one-third of the cost of a traditional new company start-up, allowing the asset owner to focus both their cash and energies on research and development.

Through this strategic partnership with CBM, on track to be the world’s largest single CGT manufacturing site with more than 700,000 sq. ft. of manufacturing and testing facilities, including 30-plus GMP suites, CGT asset owners will have unparalleled access to end-to-end services to support research and development, process development, and clinical and commercial manufacturing, including starting materials (plasmid and nucleic acid synthesis) and cell banking. Cell One Partners believes a partnership with CBM positions its clients for success via an innovative virtual company creation, management strategy, and structure while delivering a cost-effective, future-oriented model for cell and gene therapy development, manufacturing, and commercialization.

“The missions of our two organizations are aligned – to advance cell and gene therapy research from idealization to commercialization in an effort to save lives,” said Jennifer Manning, SVP of Global Strategic Partnerships at CBM. “A strategic partnership with Cell One Partners provides CGT developers access to Cell One Partners’ virtual C-Suite executives and strategic advisors and access to CBM’s expansive capacity, breadth of CGT technologies, R&D, process development and GMP manufacturing expertise, allowing innovators to focus on research, extend cash runway, simplify a complex supply chain, and accelerate the development and manufacturing of their therapies.”

About Cell One Partners Inc.

Cell One Partners (www.cellonepartners.com) is the premier global strategic consultancy and transaction advisory firm focused entirely on cell and gene therapy and regenerative medicine. Our mission is to help companies advance towards commercialization by leveraging our global network of strategic advisors with unparalleled depth of hands-on experience.

Combining our expertise and our relationships with thought leaders enables us to provide first-hand, front-line perspective and guidance on tactics, strategy and grand strategy for developers of therapies and for tools providers to accelerate value generation. Our multi-disciplined teams are in addition engaged with executing global clinical trials within a unique cost-effective model.

About The Center for Breakthrough Medicines (CBM)

Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test and manufacture life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities, including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.

Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO, providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency, and speed-to-market dedication.

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For more information, contact:
Cell One Partners Inc.
Christine Quern
cq@christinequern.com
617-650-8497

Center for Breakthrough Medicines
Keith Bowermaster, APR, CCMP
CBM@CoynePR.com
973-588-2000

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Center for Breakthrough Medicines, Nucleus Biologics, and Stoic Bio Announce Strategic Collaboration for Steady Supply of Quality Controlled Cell Culture Media to Expedite Development of Cell and Gene Therapies

March 7, 2023

San Diego, CA, Mar. 07, 2023 –In a joint effort to accelerate high-quality therapies to market, Nucleus Biologics, The Cell Performance Company™, a leading provider of custom cell culture media solutions for the cell and gene therapy industry, and Stoic Bio, a provider of sustainable technology for cell media manufacturing, have announced plans for a supply agreement with the Center for Breakthrough Medicines (CBM), a leading contract development and manufacturing organization (CDMO), whose mission is to save lives by accelerating the development and manufacture of advanced therapies. This agreement makes Nucleus Biologics the preferred supplier of cell culture media and other critical biological solutions for CBM; thus, ensuring a steady, consistent supply of this critical material with tighter quality control measures.

Nucleus Biologics’ approach to cell culture media, namely the view of media not as just another laboratory consumable, but instead as a critical raw material that can drive desired attributes of cells critical for the success of cell and gene therapy development, is a natural complement to CBM. With transparency, technology, and end-to-end solutions at the core of CBM, this partnership will serve to further advance their goals of expediting breakthroughs in cell and gene therapy.

“Our recent collaboration with Nucleus has demonstrated the critical role cell culture media can have in both the manufacturing of cell therapies and its clinical efficacy,” said Matthew Farabaugh, Chief Financial Officer at CBM. “This agreement strengthens our relationship and secures an integral part of the supply chain that allows us to get these lifesaving treatments to patients faster.”

The agreement also positions CBM as one of the early adopters of Krakatoa™, Stoic Bio’s innovative family of point-of-use media makers that allows scientists to manufacture their own media inside their laboratory or in the bioreactor suite. The cell culture media, solubilized in the Krakatoa, results in 65% less CO2 emissions than conventional media. CBM is poised to demonstrate that developing and manufacturing lifesaving therapies doesn’t have to come with a heavy environmental cost.

“We are proud to partner with CBM as their company culture, facilities, and services make them uniquely positioned to support the cell and gene therapy development community,” said David Sheehan, CEO of both Nucleus Biologics and Stoic Bio. “As we collectively work to get efficacious and cost-effective therapies into the market, the importance of media formulation and manufacturing is a foundational element.  This collaboration will leverage enabling, innovative technology to assist therapy developers from discovery to commercialization.”

With an estimated 2,200 cell and gene therapies in development, the industry needs collaborations to speed these candidates into the clinic and ultimately to approved drugs.  The CBM, Nucleus Biologics, and Stoic Bio collaboration will create a truly unique service offering that will introduce a paradigm shift in development and manufacturing to the entire industry. This partnership will serve as an example for how technology and sustainability can converge to make better therapies sustainably.   

About The Center for Breakthrough Medicines (CBM)
Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, and manufacture, life-saving therapies, and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities, including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.

Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO, providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency, and speed-to-market dedication.

About Nucleus Biologics
Nucleus Biologics, The Cell Performance Company, is the leading provider of custom cell-growth media, tools and technologies for cell and gene therapy. Their mission is to speed the time from scientific discovery to cure by delivering innovative, transparent, and cGMP products and services with the goal of disrupting the market and eliminating antiquated practices and products. Ultimately, Nucleus Biologics strives to create a new paradigm that serves both scientists and clinicians while reducing the environmental footprint of cell culture.

About Stoic Bio
Stoic Bio, a spinoff of Nucleus Biologics, is a life sciences technology company that is focused on innovating how cell culture media is being delivered to the marketplace. Through our patented systems, we are transforming media manufacturing market to point of use using powder and pods ensuring higher quality media with a reduced environmental footprint.

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For more information, contact:
btaylor@nucleusbiologics.com

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Center for Breakthrough Medicines Offers Pre-clinical Packages with Plasmids, Cell Line, and Pre-clinical Vector Manufacturing with Capacity Available Now

February 28, 2023

Comprehensive Offering Delivers Higher Quality Material & Regulatory Support for INTERACT and Pre-IND Meetings

The Center for Breakthrough Medicines (CBM), a contract development, manufacturing, and testing organization (CDMO) is packaging their pre-clinical capabilities into an IND-enabling offering to help innovator companies manufacture high quality drug substance and drug product for pre-clinical studies needed for IND-enabling activities.

Pre-clinical assessment of investigational cell and gene therapy products is a critical milestone to move programs forward while balancing limited capital allocated to this R&D stage. The importance of high-quality pre-clinical material for IND-enabling studies is often underestimated, leading to programs not having the data required to get their IND accepted and limited cash and resources to redo studies.

CBM’s IND-enabling pre-clinical package will deliver end-to-end support for pre-clinical studies and includes complimentary off-the-shelf AAV rep-cap and helper plasmids, custom plasmid manufacturing, access to a proprietary cell line, streamlined process development services, scalable pre-clinical vector manufacturing services as well as regulatory support for INTERACT and Pre-IND meetings. This package enables therapeutic developers to generate high quality material and data in under five months and positions them to move rapidly towards IND approval and GMP clinical manufacturing.

CBM’s holistic pre-clinical offerings will supply drug substance and drug product for proof-of-concept, toxicology, safety, biodistribution studies, method development, interim reference standard, development stability, and drug product development critical for IND packages. Additionally, these productions utilize similar processing techniques as would be used for GMP manufacturing, eliminating comparability risks associated with process changes.  Additional analytical testing and regulatory services are available to prepare data briefing packages for INTERACT and Pre-IND meetings. Upon pre-clinical manufacturing completion, clients have full transparency to the data from execution, production, and purification, a critical data set for the sponsor of any clinical program

“The past year has been a catalyst moment for gene therapies with approvals for AAV- and LV- based gene therapies driving renewed momentum in the pre-clinical pipeline,” said Avi Nandi, CBM’s Chief Technical Officer. “CBM’s pre-clinical program will help the next generation of gene therapy companies learn from the lessons of the last five years and lay a smoother path through clinical trials and regulatory submission.”

Visit https://breakthroughmedicines.com/process-development/ to learn more.

For highlights of pre-clinical capabilities up to 500L, see CBM’s presentation BioInsights Webinar – Ensure First-time Right GMP Production of Gene Therapies, now available for on-demand streaming.


About Center for Breakthrough Medicines (CBM)

The Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, manufacture and market life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.

Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO; providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency and speed-to-market dedication.

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For more information, contact:
Center for Breakthrough Medicines
Keith Bowermaster, APR, CCMP
CBM@CoynePR.com

Contact Us Now

Center for Breakthrough Medicines and Virion Therapeutics Announce Strategic Partnership to Manufacture Virion’s Proprietary CD8+ T cell-based Clinical Development Programs for ​Infectious Diseases and Cancers

February 22, 2023

King of Prussia, PA — February 22, 2023 — Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing critical challenges associated with the commercialization of cell and gene therapies, and Virion Therapeutics (Virion), a clinical-stage biotech company focused on the development of novel, adaptable, and accessible CD8+ T cell-based technologies focused on cancers and infectious diseases, today announced a strategic collaboration agreement wherein CBM will manufacture and partner with Virion on their checkpoint modifier clinical development programs, including the First-in-Human VRON-0200 immunotherapy for patients with chronic Hepatitis B Virus (HBV) infection.

“Virion is working to revolutionize the immunotherapy treatment landscape, and we are honored to partner with them on this bold mission as we share a common goal – to create a future free of cancer and chronic infectious diseases,” said Audrey Greenberg, Co-Founder and Chief Business Officer of CBM. “We have assembled best-in-field technical teams, supported by industry-leading product and process development, manufacturing, and testing capabilities, all located within a single, world-class manufacturing facility. We look forward to working with Virion to bring their life-saving therapies to the patients who need them most, as quickly as possible.”

One of the key programs CBM and Virion will be working on together is the VRON-2000, a pan-genotypic, global therapeutic immunotherapy for the treatment of chronic HBV infection, which is estimated to impact over 295 million people around the world. HBV infection impairs CD8+ T cells, resulting in the loss of viral control. Research has shown that VRON-0200 induces a very potent and broad CD8+ T cell response that includes responses to the core and pol regions not normally induced by the infection; as such, a new and highly functional immune response is stimulated to help clear the virus.

“Virion is delighted to expand our partnership with CBM through this key strategic collaboration,” said Virion’s Chief Operating Officer Sue Currie, Ph.D. “As we head to the clinic with our first-in-class, first-in-human program, VRON-0200, for a functional cure for HBV, as well as our other IND-enabling activities for our oncology programs, it is critical to have a manufacturing partner like CBM that has not only the capabilities and breadth of services, but also a highly dedicated and experienced team.  We are pleased to have this partnership that is also invested in our corporate goals and values.”

“CBM is a great partner to support Virion’s pipeline and help address high unmet medical needs for persons with cancer and infectious disease worldwide,” stated Andrew Luber, Pharm.D., Virion’s Chief Executive Officer. “We look forward to our continued collaborations and for their assistance in advancing our programs from early- to later-stage clinical trials.”  

About Virion Therapeutics (Virion)

Virion Therapeutics, LLC, is a science driven company whose mission is to cure cancer and chronic infectious diseases through the development of novel and accessible CD8+ T cell based immunotherapies. Our proprietary technologies combine genetically encoded checkpoint modifiers with selected and optimized target-specific antigens that are inserted into viral vectors to promote potent, prolonged, and broad CD8+ T cell responses. Founded in early 2018 to advance technology licensed from The Wistar Institute, an international leader in biomedical research with special expertise in vaccine, cancer and infectious disease research, Virion has built a best-in-class, experienced biotechnology management team, augmented by its advisory board that has extensive domain knowledge in antiviral, vaccine, and oncology therapeutic arenas.

About Center for Breakthrough Medicines (CBM) Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, and manufacture life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities, including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.

Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO, providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency, and speed-to-market dedication.

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For more information, contact:
Center for Breakthrough Medicines
Keith Bowermaster, APR, CCMP
CBM@CoynePR.com

Virion Therapeutics, LLC.
Sue Currie
Chief Operating Officer
scurrie@viriontx.com

Contact Us Now

Center for Breakthrough Medicines Launches Precision Plasmids™ Manufacturing to Accelerate Advanced Therapies into the Clinic

February 2, 2023

Superior quality Precision PlasmidsTM expedite clinical trial timelines with no wait time to start manufacturing custom plasmids

King of Prussia, PA — February 2, 2023 — The Center for Breakthrough Medicines (CBM), a contract development, and manufacturing organization (CDMO), has launched its plasmid manufacturing offering, Precision PlasmidsTM  to provide phase-appropriate plasmid on-demand for any company seeking to accelerate their path to clinic for cell and gene therapies. CBM offers NO WAIT TIMES for Precision PlasmidsTM  R&D grade for pre- and early clinical phases, and Precision PlasmidsTM Pro grade for toxicology studies, Ph1-2 vector production, or as a starting material for mRNA. Both Precision PlasmidsTM R&D and Pro are available now, while Precision PlasmidsTM GMP grade will be available in April 2023.

CBM Precision PlasmidsTM are of the highest quality, confirmed by Next Generation Sequencing (NGS) to guarantee the reproducibility of vector-based therapies that are manufactured using plasmids. Whether standalone starting material or within CBM’s integrated Genesis Vector Manufacturing SolutionTM, cell and gene therapy companies can start development and manufacturing today. Underpinned by cell banking, manufacturing, and testing at a single site, clients can expect turnaround times (TATs) of 12 weeks from a GMP master cell bank or 17+ weeks from a starting R&D plasmid.

Recognizing the global need for plasmid manufacturing capacity, challenges with securing the quality needed, and long wait times at competitor facilities, CBM will provide superior plasmids on-demand, at scale, and for every phase of development. Across a range of starting plasmids, the Precision PlasmidsTM process focuses on delivering key quality attributes:

  • • 85%+ DNA Homogeneity (Supercoiled)
  • • ABS 260/280 between 1.8 and 2.0
  • • Deep plasmid resequencing via NGS to detect variants down to 5% in addition to Sanger sequencing

Precision PlasmidsTM Pro are manufactured using a proven platform process and GMP platform analytics for preclinical and early-phase clinical trials. CBM’s robust platform was developed to accommodate multiple plasmid sizes and complexities to ensure robust manufacturing output.  In addition, the Precision PlasmidsTM Pro product utilizes CBM’s complete Quality Management System (QMS), including equipment validation and maintenance, deviation management, corrective/preventative action (CAPA) management, and 100% quality review prior to batch release.

“As a starting material for mRNA vaccines and key components for vector-based cell and gene therapies, plasmids are in high demand for the foreseeable future,” said Dana Cipriano, CBM’s SVP of Testing and Analytical Services & Plasmids. “CBM’s Precision PlasmidsTM solve the capacity challenge by bringing a platform process, multiple scales, and segregated suites to meet any clinical and commercial production needs on demand.”

Visit https://breakthroughmedicines.com/plasmid-dna-manufacturing/ to learn more.

About The Center for Breakthrough Medicines (CBM)

The Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, manufacture and market life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.

Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO; providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency and speed-to-market dedication.

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Contacts:
Center for Breakthrough Medicines
Keith Bowermaster, APR, CCMP
CBM@CoynePR.com
973-588-2000



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Center for Breakthrough Medicines Amplifies Viral Vector Manufacturing Capabilities by Licensing Asimov’s High-Performance GMP Suspension HEK293 Platform

January 18, 2023

  • • CBM to provide Asimov’s clonal HEK293 viral vector production platform to clients for preclinical and clinical manufacturing
  • • Clonal HEK293 suspension cell line is GMP-banked and qualified, ready for immediate use
  • • Compliments CBM’s Genesis Vector Manufacturing Solutions™ that accelerate the manufacturing of vector-based advanced therapies

King of Prussia, PA — January 18, 2023Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing critical challenges associated with the commercialization of cell and gene therapies, announced today an agreement with Asimov, a Boston-based mammalian synthetic biology company building tools to design living systems, to license Asimov’s clonal HEK293 suspension cell line for the production of viral vectors.

HEK293 cell lines are the industry standard for producing therapeutic viral vectors, the most widely used vehicle for the delivery of gene therapies. With the unprecedented rise in approvals for new therapies, CBM will now be able to offer its clients immediate access to a high-performance clonal GMP-qualified cell line as part of its comprehensive capabilities for vector manufacturing designed to deliver high yields and higher throughput without comprising quality. 

“Many gene therapy developers need immediate access to a cell line for the production of their therapeutics. Last year, our process development group evaluated multiple commercially-available HEK293 platforms and chose Asimov’s to provide to clients,” said Sybil Danby, Senior Vice President of Business Development and Strategy for CBM. “We believe our agreement with Asimov provides significant value to our manufacturing partners and the patients to which they are looking to deliver life-changing and lifesaving therapeutics.”

Immediately available manufacturing capabilities supported by this clonal cell line will include both GMP manufacturing (up to 1000L scale) and non-GMP productions (up to 500L). GMP productions will be conducted in CBM’s state-of-the-art, modularly designed vector manufacturing suites that support 2-5 times greater batch throughput than traditional ballroom designs while maintaining maximum flexibility in production platforms. Non-GMP productions will be conducted in CBM’s pilot plant with a proven first-time right process development approach and expert teams.

“We believe this is the initial step of many with Asimov, an industry leader in mammalian synthetic biology and cell line development,” said Avi Nandi, Chief Technical Officer at CBM. “We continue to make significant investments into our technology platforms to ensure our clients have access to an end-to-end solution that allows them to develop and manufacture at lower costs. Our goal is for rare disease therapies to be accessible to as many patients around the world as possible and our relationship with Asimov removes a key barrier to therapy developers.”

The agreement closes on the heels of CBM’s recent launch of their Genesis Vector Manufacturing Solutions™, an end-to-end offering that includes plasmid manufacturing, first-time-right process development, high-throughput GMP vector manufacturing suites, and integrated testing and analytics, supply chain, and regulatory services co-located at a single site to accelerate development and manufacturing timelines of vector-based advanced therapies.

“CBM is well known for its commitment to its clients and, most importantly, to the patients those clients serve, and we are thrilled to work with them as the need for therapeutic viral vectors continues to rise,” stated Alec Nielsen, Asimov’s CEO. “The technology to design and manufacture viral vectors is constantly evolving, which is why at Asimov we’re developing full-stack tools, from host cells, to optimized genetic systems, to bioreactor process models. Our goal is to enable partners like CBM to improve vector titers, product quality, and bioreactor scalability, in order to increase access to advanced therapies.”

About The Center for Breakthrough Medicines

The Center for Breakthrough Medicines CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, manufacture and market life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities, including process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.

Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO, providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency, and speed-to-market dedication.

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Center for Breakthrough Medicines
Keith Bowermaster, APR, CCMP
CBM@CoynePR.com

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Autolomous to Provide Digital Solutions to Center for Breakthrough Medicines to Streamline and Automate Manufacturing of Cell & Gene Therapies

January 12, 2023

London, UK and Philadelphia, US  Jan 12, 2023 – Autolomous LTD, the market-leading developer of critical manufacturing management systems for Cell and Gene Therapies (CGT), today announced a license agreement with U.S.-based Center for Breakthrough Medicines (CBM) a cell and gene therapy contract development, manufacturing, and testing organization (CDMO).

The agreement allows Autolomous to design, configure and integrate solutions for CBM utilizing the AutoloMATE® platform, a business-criticalrobust digital system, providing CBM with seamless digital connectivity in the manufacturing operations across all critical elements (e.g., facility systems, technologies) for the end-to-end cell and gene therapy (CGT) value chain.

“As the manufacturing demand of cell and gene therapies accelerates, leveraging of manufacturing insight becomes more critical,” said Alexander Seyf, CEO of Autolomous. “Autolomous will support CBM, the world’s largest single CGT manufacturing site, to enable a digital-first manufacturing platform. Autolomous will continue to deliver significant innovations, maximizing manufacturing productivity and removing bottlenecks through automation and digitization, while reducing the costs of goods to increase patient access to these life-saving therapies.”

Autolomous will help CBM convert all batch record reviews to electronic and will help consolidate the integration with the other systems leading to centralized data visibility to enhance operational learnings, streamline compliance response times, and promote shorter investigation timelines which all lead to lower costs of goods, higher productivity and greater manufacturing scalability for CBM clients.

“Partnering with Autolomous allows CBM to digitize our entire supply chain ecosystem and ensures transparency throughout the process while also providing end-to-end data integrity, complete quality assurance and control, and the automation of key parts of the manufacturing process, such as running calculations and transcribing data from Batch Manufacturing Records (BMRs),” said Jeet Sarkar, VP, Head of IT at CBM. “As we strive to make advanced therapies available and affordable to every patient, the AutoloMATE® platform positions CBM to offer our clients’ the most cutting-edge technology to boost their CGT manufacturing and save more lives.”

About Autolomous

Autolomous LTD is the market leading developer of critical manufacturing management systems for cell and gene therapies. Autolomous internationally deploys fully integrated, digitized and automated supply chain software solutions. These solutions utilize innovative technologies such as Ledger Technology (LT) and the Internet of Things (IoT) to ensure compliance with current and future regulatory requirements. As a result, Autolomous enables manufacturers to reduce costs and deliver cell & gene therapies to more patients.         

Autolomous’ platform, AutoloMATE® is a business-criticalrobust digital solution increasing efficiency, scalability, and process streamlining of the GMP manufacturing and product release of cell & gene therapies.         

Autolomous LTD is headquartered in London. The company was founded in 2019 by four professionals with combined experience covering fifty years in advanced therapies and medical practice and thirty-five years in technology, software, and business. 

About The Center for Breakthrough Medicines (CBM)

Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, manufacture and market life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities, including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.

Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO, providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency, and speed-to-market dedication.

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For more information, contact:
Autolomous LTD
Alexander Seyf
marketing@autolomous.com

Center for Breakthrough Medicines
Keith Bowermaster, APR, CCMP
CBM@CoynePR.com

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