Product/Service

Cell Therapy Manufacturing

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Fully integrated support throughout the entire product lifecycle.

World-class science focused on saving and improving patients’ lives

Cell therapies continue to advance at a rapid pace, with tremendous innovation and investment fueling novel treatments to cure diseases, improve patients’ lives, and tackle medical conditions previously regarded as difficult or impossible to treat. Center for Breakthrough Medicines (CBM) is a CDMO positioned to support the full cell therapy product lifecycle from early development to large-scale commercial production. 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-site facility, capable of fully integrated production, with flexible suites and client-centric program management.

Capabilities to develop autologous and allogeneic therapies

CBM offers completely integrated process and analytical development, cGMP manufacturing, and testing services for autologous and allogeneic cell therapies in order to support rapid advancement to clinical trials and commercial production. Speed is critical, and 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.

GMP workflows and equipment support a range of cell therapies

World-class processes and production platforms

For autologous products, we employ sophisticated scheduling, supply chain and inventory control systems aligned with in-process testing, quality control, and lot release programs to overcome manufacturing challenges. A structured process ensures integrity through Chain of Identity and Chain of Custody from receipt of donor/patient material to processing, storage, and shipment back to the Authorized Treatment Centers.

For allogeneic products, well-characterized cell banks may be scaled up with suspension systems using single-use bioreactors from 20L to 500L to meet clinical and commercial demand for the cell products.

The manufacture of the final material is based on the drug product process, determined by route of administration, target tissue, clinical protocol, and patient population.

Cell-Derived Therapies

  • CAR-T Cells
  • TCR
  • Dendritic Cell & NK Cell
  • TILs
  • Treg

Tissue-Derived Therapies

  • iPSC
  • Mesenchymal Stem Cells
  • Hematopoietic Stem Cells

CBM supports clients with agile, flexible cell capabilities

Rapid development and full program transparency

Our process development team begins by transferring in knowledge from our client, followed by work to ensure a robust and scalable process. CBM's platform enables clients to reduce the development timeline and deliver for patients sooner. We map the entire journey of your product from early development to commercialization, building in the requisite milestones to track progress and ensure quality all the way down the path. We are fully transparent in our partnerships, with an experienced program management team giving you clear oversight of your project through regular updates, on-site access, and the potential for dedicated office space with our Partner-in-Plant program.

Our quality control (QC) team operates in direct conjunction with manufacturing for method transfer, optimization, qualification, and validation. The labs are directly adjacent to production for rapid and seamless cGMP testing. Core cell therapy methods include:

  • qPCR, rapid micro methods, flow cytometry, ELISA, and automated cell counting.
  • Incoming raw material, in-process and final product testing.
  • Network of qualified contract testing laboratories to supplement in-house capabilities.
  • Environmental, personnel and utility monitoring.

Analytical methods development is performed in-house

Drug Substance

  • Potency
    • Viability
  • Safety
    • Mycoplasma PCR
  • Identity
    • Immunophenotype

Drug Product

  • Potency
    • Transgene Functional Assay
    • Viability
    • Immunophenotype
  • Safety
    • Endotoxin
    • RCL Molecular Assay
    • Microbiological Control of Cell Suspension

Release, In-Process, Characterization

  • Vector Copy Number
  • Transduction Efficiency (Flow Cytometry)
  • % T Cells (Flow Cytometry)
  • Transgene ID
  • Characterization
  • Appearance
  • Endotoxin
  • Gram Stain

Safety & Stability

  • Sterility, Rapid Sterility
  • Mycoplasma, Rapid Mycoplasma
  • RCL

The Center for Breakthrough Medicines