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Center for Breakthrough Medicines plans for an even larger dive into cell therapy manufacturing

CBM's new 1 million square foot Cell Therapy Manufacturing facility

In an email to Endpoints News, John Lee, VP and head of cell therapy at CBM, said its new one million square foot cell therapy expansion will include 90,000 square feet of GMP manufacturing space as well as offices and warehouse space. Lee also said that the facility’s cost will be in the hundreds of millions, but no exact figure was given. Once completed, this will be one of the largest producers of cell therapy in the world.

“We have leveraged knowledge gained from our current build and forward engineered the facility to enable modularity and to increase efficiency to better serve clients (and patients). Modular suite design across approximately 90,000 square feet of Grade-B GMP space will enable agility and flexibility to accommodate an array of processes,” Lee said in an email.

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June 21, 2022

CBM accelerates plans to add capacity for 10,000 patient therapies

The Center for Breakthrough Medicines (CBM) and Discovery Labs respond to the critical shortage of cell therapies by accelerating plans to build capacity to produce over 10,000 patient therapies.

The plant expansion at CBM’s King of Prussia, Philadelphia, which was initially outlined to begin planning in 2024-2025, has now been started due to “the critical lack of cell therapy supply,” a spokesperson for CBM told us.

“We are also seeing shortages for already approved products, long waitlists, and doctors being forced to choose which of their patients get the scarce CAR T manufacturing slot for their treatment center. We want to make sure there is capacity available when many of the products now in the clinic become commercial.”

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June 17, 2022

Discovery Labs proposes 1 million square feet of new life sciences space in King of Prussia

CBM is a contract development and manufacturing organization based in the King of Prussia

Center for Breakthrough Medicines, which is housed within the 3-million-square-foot Discovery Labs bio-innovation hub, said this week it plans to accelerate its plans to build capacity to manufacture more than 10,000 patient cell therapies.

The King of Prussia contract development and manufacturing organization said the move is in direct response to the critical supply shortage of cell therapies for patients battling cancer.

Joerg Ahlgrimm, CEO of the Center for Breakthrough Medicines, said the organization originally expected to begin the planning process for building its manufacturing capacity in 2024 or 2025. Now, he said, the process will begin right away.

“Everything we see tells us once these therapies hit the commercial market, the demand is very, very high,” Ahlgrimm told the Business Journal.

Ahlgrimm said as more experimental cell therapies enter the human-testing stage, the demand for samples to be used in clinical trials is also growing.

“We are acutely aware of the importance of getting these life-saving therapies to patients immediately,” he said.

The exact cost of the manufacturing expansion will be determined during the planning process, but it is expected to cost hundreds of millions of dollars over the coming years. When completed, the center’s cell therapy manufacturing suites and supporting infrastructure will have the ability to produce treatments for more than 10,000 patients per year.

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June 16, 2022

World’s Largest Cell Therapy Manufacturing Operation Accelerated by The Center for Breakthrough Medicines  

CBM’s facilities currently provide biotechs with viral vector, cell therapy, and plasmid DNA manufacturing, as well as extensive process and analytical development and testing capabilities.

The state-of-the-art manufacturing facilities will be engineered and future-proofed to support a range of cell types and complex manufacturing processes, designed to maximize efficiency and minimize costs.

To facilitate the development of next-generation cell therapies specialized technologies will be implemented to allow for autologous manufacturing, high-fidelity gene-editing and a fully automated process.

To attain the specific manufacturing needs of the cell therapies industry CBM is working with academic institutions and innovator companies. Their aim is to lower costs, shorten timelines and scale manufacturing procedures to advance the development of these critical products and ultimately get them to patients.

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June 15, 2022

Center for Breakthrough Medicines Accelerates Plans to Build the Largest Cell Therapy Manufacturing Operation in the World

CBM Responds to Critical Lack of Cell Therapy Manufacturing Supply by Adding Capacity for More than 10,000 Patients

King of Prussia, PA, June 14, 2022 – The Center for Breakthrough Medicines (CBM) in partnership with the Discovery Labs announced today the acceleration of plans to build capacity to manufacture more than 10,000 patient therapies in direct response to the critical shortage of cell therapy supply, which will help patients win their courageous battles against cancer.

“We are acutely aware of the importance of getting these lifesaving therapies to patients immediately,” said Joerg Ahlgrimm, Chief Executive Officer of Center for Breakthrough Medicines. “We share their race against time and apply extreme urgency to everything we do. There is a critical shortage of cell therapy manufacturing in the world forcing doctors to make heartbreaking decisions resulting in patient deaths that could be avoided. We focus every day on our patients and their families, so the intense urgency of our mission is never compromised.”

Planning has begun on a massive expansion of CBM’s cell therapy manufacturing suites and supporting infrastructure which when completed will have the ability to produce treatments for more than 10,000 patients per year, the largest in the world. While a final cost has yet to be determined, the expansion is expected to cost hundreds of millions of dollars over the coming years.

CBM is currently providing process development, analytical development and testing capabilities with extensive viral vector, cell therapy and plasmid DNA manufacturing coming online monthly.  

“Everyone at CBM works to save lives. This decision not only provides critically needed manufacturing capacity but also emphasizes CBM’s unwavering commitment to deliver advanced therapies for patients in need,” said John Lee, Vice President and Head of Cell Therapy at CBM. “CBM’s steadfast commitment to the patient is underscored by this decision.”

CBM’s facility will manufacture cell therapies across indications including oncology immunotherapies and regenerative medicine applications. The state-of-the-art facilities will be forward engineered with modular designs to adapt an array of cell types, manufacturing processes, and capacity demands to maximize efficiency while minimizing costs. To further enable next-generation cell therapies, the CBM team will implement rapid autologous manufacturing, high-fidelity gene-editing capabilities, and fully automated processes prior to the facility coming online.

CBM is working with multiple academic institutions and innovator companies to advance these critical modalities, lower cost, shorten timelines and scale manufacturing of approved therapies so that all patients can receive treatment.

About The Center for Breakthrough Medicines
CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complimentary testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

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Media Contact:
Keith Bowermaster, APR, CCMP
Coyne Public Relations
973-588-2000
kbowermaster@coynepr.com

June 13, 2022

Weathering The Biotech Storm: Accelerating Manufacturing, Controlling Cost, And Managing Risk With A Strategic CDMO Relationship

By Joerg Ahlgrimm, CEO, Center for Breakthrough Medicines

Following an exuberant investment period during the past several pandemic years, strong headwinds are now challenging the biotech industry. Supply chain snags, a scarcity of skilled talent for technical roles, and a skittish investor climate are severely impacting corporate valuations and are causing some retrenchment in early-stage biotechnology companies.

The promise of and demand for cell and gene therapies (CGT) has never been greater given remarkable advancements including a ten-year follow-up of one of the first patients treated with CAR-T cell therapy for chronic lymphocytic leukemia showing he remains cancer-free and the word “cure” being used to describe the treatment’s success, as well the recent approval in Europe of PTC Therapeutics’ gene therapy, Upstaza, to treat AADC deficiency. However, the complexities and financial pressures of developing and manufacturing future life-saving treatments is threatening innovation.

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June 6, 2022

Center for Breakthrough Medicine appoints Joseph Lingle as Chief People Officer

Thirty Year Veteran in Operations and Human Resources Joins Executive Team

KING OF PRUSSIA, Pa., June 1, 2022 — The Center for Breakthrough Medicines (CBM) announced today the appointment of Joseph (Joe) Lingle as Chief People Officer. In his role, Lingle will oversee all Human Resources (HR) activities, including talent management, workplace experience, and Diversity, Equity, and Inclusion (DE&I).

“We are thrilled to have Joe join our executive team, “said Joerg Ahlgrimm, Chief Executive Officer of CBM. “Not only is his unique background in engineering and biotechnology a perfect fit for CBM, but he is a roll-up his sleeves team player who will make an immediate and profound impact on our company, its employees and our many clients.”

Prior to joining CBM, Lingle spent the past two years focused on the integration and expansion of the cell therapy operations at Bristol Myers Squibb to support the commercialization and supply of two CAR-T assets (ABECMA® and Breyanzi®). This work included partnerships with operations and HR stakeholders to stand up new CAR-T manufacturing sites in the U.S. and Europe, drive talent planning and culture initiatives for the organization, and provide trusted counsel to key executives as their HR Business Partner.

A seasoned executive, Lingle has more than 30 years of experience in diverse roles in engineering, biotech manufacturing, supply chain/logistics, change management, and global operations with large pharma organizations (including Merck, GlaxoSmithKline, and Novartis) before transitioning into executive level roles in HR within the pharma/biotech space as well as other industries.

“I am passionate about the cell/gene therapy space, in large part due to the impact cancer and other diseases have had on my family and friends,” said Lingle. “Our employees are our most valuable asset in achieving CBM’s noble mission of saving lives by accelerating the development and manufacturing of advanced therapies, and I am beyond thrilled to do my part by leading the HR function and ensuring we hire and retain the best talent to help us get there.”

Lingle earned his Bachelor and Master of Civil Engineering degrees from Villanova University and has completed executive coursework in finance and strategy at both Harvard University and the Massachusetts Institute of Technology. He has also published several papers, is a Lean Sigma Green Belt and earned multiple certifications and accreditations in HR and change management.

A resident of Yardley, PA, with his wife, Maureen, Lingle enjoys hiking, travel, golf, coaching, and staying connected to his alma mater (Villanova) through volunteer activities with the college of engineering and lacrosse programs

About The Center for Breakthrough Medicines
CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector manufacturing, cell banking, cell processing, and a full suite of complimentary testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

June 1, 2022

iECURE Enters Agreement with Center for Breakthrough Medicines (CBM) to Supply Materials for Future Clinical Programs

Partnership to focus on manufacturing clinical materials for future clinical studies

PHILADELPHIA–(BUSINESS WIRE)–iECURE, a gene editing company focused on mutation-agnostic in vivo gene insertion, or knock-in, editing for the treatment of liver disorders with significant unmet need, and Center for Breakthrough Medicines (CBM) today announced the companies have entered into a strategic collaboration wherein CBM will produce and supply Good Manufacturing Practices (GMP)-grade adeno-associated virus (AAV) for use in iECURE’s future clinical studies to enable development of iECURE’s programs with the shared mission of accelerating the availability of these potential treatments to the patients.

“Our approach to gene editing relies on highly complex manufacturing processes, and we are eager to establish partnerships to ensure a reliable supply of GMP materials for future clinical development,” said Paul Firuta, Chief Operating Officer of iECURE. “CBM was able to offer us significant amount of guaranteed capacity with scheduling flexibility and we are confident that they will be a strong partner with their state-of-the-art facilities and end-to end capabilities.”

“iECURE’s approach to gene editing is quite innovative and has the potential to bring significant hope to patients and families facing devastating diagnoses,” said Audrey Greenberg, Chief Business Officer and Co-Founder of CBM. “Our ability to provide customizable clinical and commercial GMP manufacturing solutions integrated with industry-leading comprehensive in-process testing, quality control, and lot release programs allows us to support our partners like iECURE through the entirety of their product lifecycle and is aligned with our mission to bring life changing medicines to patients in need.”

About iECURE

iECURE is a gene editing company focused on developing therapies that utilize mutation-agnostic in vivo gene insertion, or knock-in, editing for the treatment of monogenic liver disorders with significant unmet need. We believe our approach has the potential to replace and restore the function of a dysfunctional gene by knocking-in a healthy copy, regardless of mutation, to offer durable gene expression and long-term, potentially curative, therapeutic benefit. Our management team has extensive experience in executing global orphan drug and gene therapy clinical trials and successfully commercializing multiple products. We intend to leverage our team’s core strength in research and development strategy to identify what we believe to be the most suitable target and modality for our product candidates to address particular liver diseases. We are collaborating with the University of Pennsylvania’s Gene Therapy Program, or GTP, led by James M. Wilson, M.D., Ph.D., to utilize GTP’s world-class translational expertise and infrastructure, which has helped generate our initial pipeline of potential product candidates. For more information, visit www.iecure.com and follow on LinkedIn.

About Center for Breakthrough Medicines (CBM)

CBM is a cell and gene therapy contract development and manufacturing organization (CDMO) based in the heart of Philadelphia’s Cellicon Valley. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector, cell therapy and a full suite of testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality.

Contacts
Investors:
David Garrett
dgarrett@iecure.com

Media:
Danielle Cantey
Canale Communications
danielle.cantey@canalecomm.com

May 25, 2022

Center for Breakthrough Medicines Beats Back on the 2022 Biotech Bear Market with Rapid Hiring and Expansion

“Since its launch, The Center for Breakthrough Medicines (CBM) has seen exponential growth as a concierge life sciences services organization. That growth was highlighted during the first quarter of this year with the hiring of approximately 200 additional people.

Audrey Greenberg, co-founder of CBM and also the executive director of The Discovery Labs, said the successful growth seen at CBM is a testament to the great company culture the organization has built since its founding in 2019. Among the hires in the first quarter of this year is John Lee, PhD, the new Vice President and Head of Cell Therapy. Lee, an accomplished CAR-T immunobiologist, was hired in March to lead cell therapy programs at CBM. Prior to joining CBM, Lee established the Cell Therapy Platform team at Janssen Pharmaceuticals. He also served as head of Oncology Cell Therapy at GlaxoSmithKline.

Lee reports to CBM’s Chief Executive Officer Joerg Ahlgrimm, who was brought on to build out the organization’s capacity to support the manufacturing of cell and gene therapies. Ahlgrimm, who previously served as chief operations officer for the organization, joined CBM after serving as Head of Global Operations Pharma Biotech and Nutrition at Lonza.”

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May 17, 2022

Considerations To Get Your CAR T Testing Strategy Right

“Less than five years after the first approval of a CAR T therapy in 2017, momentum for CAR T and other cell therapies has never been greater.

Given their experience reviewing and approving six CAR Ts across 10+ indications, the FDA released a draft guidance “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products” in March of 2022. As a trusted partner to cell therapy product developers such as Achilles Therapeutics, we at the Center for Breakthrough Medicines (CBM) identified three considerations – testing CAR-T starting material, establishing manufacturing process controls, and implementing robust testing analytics – that our clients prepare for as part of their analytical development prior to finalization of the guidance. This will help to monitor and report on the right critical quality attributes (CQAs) of their CAR T products which is needed for characterization of the product’s safety and efficacy that is reported to health authorities.”

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May 10, 2022