U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

cell banking

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cell & viral bank characterization

Regulatory agencies worldwide require a continuing and well-controlled supply of the specific cell lineage that is integral to the manufacturing process of a biopharmaceutical.

Let WuXi AppTec’s team of experienced cell culture specialists – with the oversight of our highly trained quality assurance unit – manufacture your banks to the highest standards to meet global expectations.

 

Cell Banking Services

Batch Record Development
•    Consultation to determine needs
•    Clarify raw materials and process requirements
•    Creation of a batch record to document a comprehensive cell line history, growth profile and safety & characterization data

Cell Expansion & Harvest
•    Capacity to manufacture 10-1,200 vials
•    Campaign production approach
•    Stringent raw materials release program
•    Thorough seed stock contamination acceptance screening
•    Validated change-over and cleaning procedures

Testing & Characterization
•    Recovery viability
•    Growth
•    Complete biosafety
•    Genetic characterization

Documentation
•    100% QA raw data review
•    QA-approved Certificate of Analysis

 

Cell Line Experience

Human:  Embryonic Retina (PER-C6)  •  Spleen  •  Kidney (MRC-5)
•  Neuroblastoma cells  •  Embryonic Kidney (HEK 293)  •  Umbilical cord

Murine:  Hybridoma  •  Hybridoma Sp2/0  •  Myeloma (NSO)

Monkey:  Africa Green Monkey (VERO)  •  Rhesus Monkey (LLC MK2)

Insect:  Drosophila S2  •  Fall armyworm Sf9

Hamster:  Ovary (CHO)

Canine:  Kidney (MDCK)

Chicken:  Embryo

 

Cell Culture Platforms

•  T-Flasks  •  Shaker Flasks  •  Spinner Flasks
•  Roller Bottles  •  Cell Factories  •  Hyperstacks

 

 

cell & viral bank
characterization

 

Cell Line Characterization Experience

A successful characterization program has many essential elements, including identity and detection of micro-organisms and mycoplasma. The most highly customized element is the detection of adventitious virus. WuXi AppTec is the clear leader in this field, with exceptional expertise and over 20 years of experience.

  • Complete assay panels performed for hundreds of cell/viral banks and allogeneic/autologous cell therapy products.
  • Strong track record for supporting IND, BLA and market approvals by regulatory agencies worldwide.
  • Senior staff that serves on industry task forces to remain current on regulatory policies.

Program Features

  • Over 50 cell lines of human and animal origin and over 60 human and animal viruses available as positive controls.
  • Over 40 viral PCR probes and over 100 PCR assays developed and implemented to assess potential virus contamination.
  • Next-generation technologies including AgentID™/AgentSCREEN™ for adventitious agent detection of raw materials & cell/viral banks.
  • Expert advice/consulting on worldwide regulatory requirements
  • Advising on strategy and performance of cell line characterization studies, and consulting on full program of biosafety testing.
  • Custom assays developed for unique cell lines and viruses as needed.
  • Dedicated virology, molecular biology, cell biology, and analytical labs of over 21,000 square feet.
  • 16,000 square feet of cGMP manufacturing space for manufacture of master (MCB) and working (WCB) cell banks