The Center for Breakthrough Medicines (CBM) is a single-source CDMO providing end-to-end solutions for the development, manufacturing, and commercialization of advanced therapies.
Our fully-integrated facility is positioned to support innovative cell and gene therapy programs at every stage of the development cycle to rapidly deliver lifesaving therapies to patients that need them.
Our process development team can seamlessly integrate your cell therapy or gene therapy’s existing processes or develop custom processes tailored to your project’s needs from the ground up. Our PD scientists have deep technical expertise and have completed a tech transfer on a 200L run in under four months. These experts can provide continuous support throughout your program’s progress, ensuring quality, scalability, and regulatory compliance from discovery through commercialization. CBM’s pilot plant manufactures GMP scale batches to ensure a smooth transition to commercial scale, while conducting parallel stability studies to expedite project timelines.
Robust process development – optimized and tailored to your project’s needs – lays the foundation for your program’s success by increasing yields, minimizing costs, and consistently delivering high quality products.
20+ Vector Manufacturing Suites
20+ Cell Therapy Manufacturing Suites
Our analytical development and testing team’s strategic approach to process development accelerates development timelines by executing testing in conjunction with advanced therapy programs. CBM’s expansive testing capacity allows customers to consolidate outsourcing testing partners to a single comprehensive source with no wait times, saving sample volume needed and delivering results in a fraction of the time. Our experts can develop novel analytical methods for your cell or gene therapy or transfer existing methods and perform qualification and validation services spanning the entire spectrum of FDA domains, including safety, potency, purity, stability, and identity.
We offer next-generation sequencing, mass spectrometry, droplet digital PCR and digital PCR, measurement and characterization of empty, full, and partial capsids, and bioassays and potency packages.
100+ Analytical Assays
200,000 SqFt of Lab Space
With dedicated capacity for the manufacture of R&D-grade, GMP-like, and GMP plasmid, we can optimize costs, streamline processes based on your phase of development, and eliminate the need to seek out an alternative supplier for your project’s starting materials. All grades of plasmid are supported by on-site design, process development (including scale-up and tech transfer), and phase-appropriate testing for precise quality.
In addition to plasmid manufacturing, we can also support your project with long-term stability programs and cell banking, both of which are integrated into our single site, keeping your program streamlined and efficient from end to end.
20,000 SqFt. of Plasmid DNA Production Space
200L GMP Fermentation, Harvest & Purification
Our purpose-built facilities are actively building capacity to house 20 BLA-ready, cGMP-compliant suites dedicated to the end-to-end production from starting material to drug substance and drug product capabilities for viral vector– including Adeno-associated virus (AAV), Lentivirus (LVV), HSV, Adenovirus, and others –to efficiently bring your cell or gene therapy to clinical and commercialization. Our viral vector manufacturing is complemented by a fully integrated supply chain, first time right process development, integrated on-site testing and plasmid production, ensuring a robust supply of starting materials with consistently high quality, as well as an 88% increase in throughput and a 25% reduction in cell line COGS.
Our vector manufacturing suites are purpose-built to deliver the flexibility and scalability required to develop novel viral-based therapeutics. Through our academic partnerships, our customers have access to the lab that pioneered the first gene therapy.
2,000L+ Suspension Process
15-30 Batches Annually Per Suite
CBM offers scalable manufacturing solutions for both autologous and allogeneic cell therapies, including planned additional capacity for more than 10,000 autologous doses per year. Our single-source model encompasses plasmid and vector supply, starting materials manufacturing, and on-site sterility testing. This fully integrated CDMO offering is designed to support your cell- or tissue-derived therapy through the entire product lifecycle, streamlining process development, manufacturing, and quality control to minimize COGS, reduce vein-to-vein time, and facilitate the rapid commercialization of lifesaving treatments.
Our scalable allogeneic suspension systems and facility’s wide band of autologous dosage capacity allow your program to move into and through development quickly, regardless of its phase or scope.
20L-500L Allogeneic Suspension Systems
30,000+ Autologous Annual Dose Capacity
Our process development team can seamlessly integrate your cell therapy or gene therapy’s existing processes or develop custom processes tailored to your project’s needs from the ground up. Our PD scientists have deep technical expertise and have completed a tech transfer on a 200L run in under four months. These experts can provide continuous support throughout your program’s progress, ensuring quality, scalability, and regulatory compliance from discovery through commercialization. CBM’s pilot plant manufactures GMP scale batches to ensure a smooth transition to commercial scale, while conducting parallel stability studies to expedite project timelines.
Robust process development – optimized and tailored to your project’s needs – lays the foundation for your program’s success by increasing yields, minimizing costs, and consistently delivering high quality products.
20+ Vector Manufacturing Suites
20+ Cell Therapy Manufacturing Suites
Our analytical development and testing team’s strategic approach to process development accelerates development timelines by executing testing in conjunction with advanced therapy programs. CBM’s expansive testing capacity allows customers to consolidate outsourcing testing partners to a single comprehensive source with no wait times, saving sample volume needed and delivering results in a fraction of the time. Our experts can develop novel analytical methods for your cell or gene therapy or transfer existing methods and perform qualification and validation services spanning the entire spectrum of FDA domains, including safety, potency, purity, stability, and identity.
We offer next-generation sequencing, mass spectrometry, droplet digital PCR and digital PCR, measurement and characterization of empty, full, and partial capsids, and bioassays and potency packages.
100+ Analytical Assays
200,000 SqFt of Lab Space
With dedicated capacity for the manufacture of R&D-grade, GMP-like, and GMP plasmid, we can optimize costs, streamline processes based on your phase of development, and eliminate the need to seek out an alternative supplier for your project’s starting materials. All grades of plasmid are supported by on-site design, process development (including scale-up and tech transfer), and phase-appropriate testing for precise quality.
In addition to plasmid manufacturing, we can also support your project with long-term stability programs and cell banking, both of which are integrated into our single site, keeping your program streamlined and efficient from end to end.
20,000 SqFt. of Plasmid DNA Production Space
200L GMP Fermentation, Harvest & Purification
Our purpose-built facilities are actively building capacity to house 20 BLA-ready, cGMP-compliant suites dedicated to the end-to-end production from starting material to drug substance and drug product capabilities for viral vector– including Adeno-associated virus (AAV), Lentivirus (LVV), HSV, Adenovirus, and others –to efficiently bring your cell or gene therapy to clinical and commercialization. Our viral vector manufacturing is complemented by a fully integrated supply chain, first time right process development, integrated on-site testing and plasmid production, ensuring a robust supply of starting materials with consistently high quality, as well as an 88% increase in throughput and a 25% reduction in cell line COGS.
Our vector manufacturing suites are purpose-built to deliver the flexibility and scalability required to develop novel viral-based therapeutics. Through our academic partnerships, our customers have access to the lab that pioneered the first gene therapy.
2,000L+ Suspension Process
15-30 Batches Annually Per Suite
CBM offers scalable manufacturing solutions for both autologous and allogeneic cell therapies, including planned additional capacity for more than 10,000 autologous doses per year. Our single-source model encompasses plasmid and vector supply, starting materials manufacturing, and on-site sterility testing. This fully integrated CDMO offering is designed to support your cell- or tissue-derived therapy through the entire product lifecycle, streamlining process development, manufacturing, and quality control to minimize COGS, reduce vein-to-vein time, and facilitate the rapid commercialization of lifesaving treatments.
Our scalable allogeneic suspension systems and facility’s wide band of autologous dosage capacity allow your program to move into and through development quickly, regardless of its phase or scope.
20L-500L Allogeneic Suspension Systems
30,000+ Autologous Annual Dose Capacity
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The results? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
Center for Breakthrough Medicines Launches Genesis Vector Manufacturing Solutions™ with New State-of-the-Art Vector Suites to Accelerate the Commercialization of Advanced Therapies
Accelerating AAV Analytical Development And Testing With Advanced Methods And Comprehensive Solutions
A Contract Development and Manufacturing Organization (CDMO) is a company within the biotechnology and pharmaceutical industry that provides outsourced drug development, manufacturing, and testing services to innovator companies. Biotechnology and pharmaceutical companies partner with CDMOs to have their advanced therapies drug development, manufacturing, and testing carried out by a third-party expert. CDMO’s offering testing services can also be referred to as CTDMO (Contract Testing, Development and Manufacturing Organization)
In the broadest sense, gene therapy is the use of genetic material in the treatment or prevention of disease. Transferred genetic material changes how a single protein or group of proteins is produced by the cell. Gene therapy can be used to reduce levels of a disease-causing version of a protein, increase production of disease-fighting proteins, or to produce new or modified proteins. CBM has the expertise and production agility to keep your project moving, as well as crucial knowledge of the regulatory environment. CBM can either develop and optimize client-specific processes or tech transfer in established processes.
Cell therapy is the transfer of new, healthy live cells into a patient to help reduce the impact of or cure a disease. The cells may originate from the patient (autologous cells) or a donor (allogeneic cells). The transferred cells help to replace damaged cells as well as modulate the function of the patient’s cells through expression of factors or direct interaction. Advances in the understanding of disease biology and major innovations in gene editing, protein engineering and cell culture technology have created a highly fertile scientific environment in which cell therapy research is flourishing. CBM is dedicated to bringing capabilities to the full cell therapy manufacturing process from early development to large-scale commercial production to eliminate existing bottlenecks, so patients get the treatment they need. Our team has unparalleled prior experience in advancing cell therapies to IND and all the way to commercialization, and our clients can leverage our large single source facility, capable of fully integrated production, with flexible, forward-engineered suites and client-centric program management.
CBM’s viral vector capabilities efficiently and consistently delivers high yields in AAV, Lentivirus, HSV and Adenovirus vectors, accelerating the development of new therapies.
CBM has one of cell therapy’s most experienced teams and the largest single site facility in the industry. There is no greater centralization of expertise.
Our team brings a wealth of experience from biopharma and advanced therapy CDMOs, ensuring that there is no safer place for your product.
