Cell Line Characterization

Growth, Identity, Purity, Stability, Safety – Confirmed Swiftly & Accurately

With the type of experience gained only through hundreds of cell line characterization studies, our multiple, dedicated labs hold expertise across a wide range of biological disciplines. Which tests to conduct, at which stage – and the quality oversight required – is where this comprehensive know-how makes the critical difference.

Cell Line Growth

As part of our integrated cell bank manufacturing program, all CLC programs require cell line growth characteristics well-documented with the necessary written assessment as a GMP report.  Our team also performs a wide variety of cell line identity assays, including isoenzyme analysis or, if necessary, cell-marker identification assays using flow cytometry or ELISA.

Sterility & Mycoplasma Testing

With exacting standards, our labs conduct tests applicable for your particular cell line characterization program

  • Bacteriostasis, fungistasis, sterility
  • Mycoplasmastasis and mycoplasma detection assays
  • All microbial assays follow harmonized USP/EP/JP protocols
  • CFR and Points-to-Consider protocols are available
  • Access to BacT® Alert and other alternate methods
Adventitious & Infectious Virus Detection

To illustrate our commitment to accurate, complete detection, we use high-resolution Transmission Electron Microscopy (TEM) to recognize viral contamination that is otherwise unsuspected, or unable to be discerned by ELISA, PCR or other methods.

Stability

As an eventual and critical regulatory filing component, the genetic stability of your production cell line must be well understood, from Master Cell Bank to the End of Productions Cells. Our exhaustive program encompasses a wide variety of molecular biology techniques including:

  • Southern & Northern Blotting
  • qPCR for Copy Number Determination
  • DNA & RT-PCR cDNA Sequencing

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