Biologics Services

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When well-characterized cell stocks are needed for assay development and/or conducting screening or lot release tests, generating the cell stocks in-house can be time-consuming and a drain on critical resources such as facilities, equipment and personnel. Outsourcing your cell stock manufacturing – either GMP or non-GMP – to WuXi AppTec is an economical and time-saving alternative.

With our comprehensive expertise, state-of-the-art facilities and robust quality systems, WuXi AppTec can provide assurance that your cell stocks will be manufactured to the highest standards of quality. And we utilize over 25 years of biosafety and characterization experience in performing screens of your cell line for adventitious agents.

Capabilities

  • Familiarity with a wide variety of different tissue types from the following species:
    HamsterSimianBovineAvian
    MurineInsectPorcineEquine
    HumanCanineFeline
  • Cell banks/stocks quantity from 10 to 1200 vials
  • Expertise with both adherent and suspension cells
  • In-depth knowledge of various media types used in multiple cell culture methods including:
    T-FlasksShaker Flasks
    Cell FactoriesSpinner Flasks
    Roller BottlesBioreactors (small scale)

Facilities

The cell stock manufacture facility at WuXi AppTec offers clients an opportunity to manufacture cell stocks grown to their specifications, under exacting standards and (if applicable) QA oversight, and within a secure, controlled and monitored environment. All work is batch record- and/or SOP-driven and documented, and performed in ultra-clean tissue culture suites by gowned, highly skilled personnel. Each GMP suite features single-pass, positive-pressure, HEPA-filtered air. Flow within each suite is unidirectional, with entry and exit air locks. All cell culture work is conducted within certified ISO Class 5 (Class 100) laminar flow biosafety cabinets, and cells are expanded within temperature mapped and validated incubators. The GMP suite complex operates under a stringent security program that includes redundant temperature monitoring; 21 CFR, Part 11-compliant computer systems; fire protection; and an auxiliary back-up power generator. In addition, the entire facility is monitored by a security system tied into a central station where a 24-hour watch is maintained on system signals.

Services

Services in support of cell stock manufacture include:

  • Cell Line Cloning & Development
  • Documentation / Batch Records
  • Cell Expansion & Harvest
  • Testing (including recovery viability and complete biosafety & characterization)
  • Reports (CofA for GMP; R&D/custom)
  • Cryopreservation, Storage & Shipment
For more details on these services, view/download the PDF above.

Experience

  • 25-year history in the manufacture of cell stocks.
  • 40-45 GMP cell banks manufactured each year.
  • Cell stocks created/maintained for over 50 cell lines used in WuXi AppTec assays.
  • Thorough understanding of testing to address worker safety and cell stock performance for cell lines used in drug screening or quality control assays.
  • Over 60 viruses available as positive controls, and over 100 PCR and infectivity assays developed and implemented to assess potential virus contamination of cell stocks.

Program Features

  • Seven dedicated GMP cell banking suites and seven additional cell culture rooms for GMP or non-GMP projects.
  • Capacity to perform large-scale cell expansion projects including experience in producing 50 billion (5.0 x 1010) cells/lot using 40 stack cell factories.
  • Full in-house testing capabilities for biosafety and cell line characterization testing.
  • Adaptable documentation systems (for either GMP or non-GMP cell stock creation).
  • Experienced, highly trained staff.
  • Custom assay development.