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Mammalian and Other Eukaryotic Cell Bank Characterization

The characterization and testing of cell banks is a critical component of the control of biopharmaceutical or biological products. The objective of this testing is to confirm the identity, purity, and genetic stability of the cell line. The potential risk of introducing adventitious agents such as bacteria, mycoplasma, fungi, or viruses to the biopharmaceutical must be eliminated or minimized. Therefore, cell banks are thoroughly tested to ensure the starting material for your product is free from contamination. The Biopharmaceutical Services (BPS) group at Charles River works closely with clients to develop cost-effective, scientifically sound, validated testing programs for the characterization of cell banks used to produce biopharmaceutical products. BPS offers characterization programs that include testing panels designed to detect microbial and viral contaminants, verify cell line indentity and confirm genetic stability of the Master Cell Banks (MCBs) and Working Cell Banks (WCBs).

Service Areas

· Identity testing · Purity testing · Stability testing - Copy number determination - DNA and RNA sequencing - Restriction map analysis · Virological safety testing

Cell Banking Experience

· Mammalian · Insect · Avian · Stem Cell

Characterization for a Typical Mammalian Cell Bank

Day 0 Day 28 Day 42 Day 49 Day 70 Day 84 Day 98 Day 118

Pre-bank testing - 28 days MCB production and release - including Post-bank viability, B&F, sterility, mycoplasma - 90 days Cell growth for characterization - 14 days MCB characterization PBRT - 21 days S+L - 42 days Isoenzyme & karyology - 70 days Bovine adventitious agents (optional) - 42 days Porcine adventitious agents (optional) - 42 days In vivo virology - 56 days TEM - 56 days MAP with LCMV challenge - 56 days HAP - 56 days

Actual schedules may vary due to the differences in individual cell banks, and the time to completion may be shortened depending upon the testing regimen selected.

The BPS group provides clients with a wealth of experience in cell bank characterization. Our cell bank characterization programs include testing of MCBs, WCBs, and End-of-Production Cells (EOPCs), which are cells at the limit of in vitro age as designated by the International Conference on Harmonisation (ICH). BPS concentrates on developing client-focused project designs tailored to the product, its stage of development, and the required regulations. A list of potential assays associated with the characterization of mammalian and other eukaryotic cell banks is outlined below. While many of the key aspects of testing are similar across the industry, our team of experts and dedicated programs aim to ensure an appropriate testing plan is developed for your specific cell line.

Assays for Testing Cell Banks

- Bacteriostasis and fungistasis - Sterility - Mycoplasma (cultivable and non-cultivable strains or by PCR) - Mycobacterium

Determines the presence of contaminating organisms

- Isoenzyme analysis/DNA fingerprinting and karyology - Copy number determination - Restriction map analysis - DNA/RNA sequencing

Cell line identification and genetic stability

- Transmission electron microscopy - Reverse transcriptase PCR assay (PBRT) - Retroviral infectivity assays - In vitro and in vivo adventitious virus testing - PCRs for species-specific viruses

Determines the presence of contaminating organisms

- Mouse, rat and hamster antibody production assays

Antibody production assays

North America: 1.877.274.8371 · Europe: +44 (0) 1875 614545 AGENTS: Australia: +61 (0) 3 9208 4222 · India: +91 (0) 22 2685 8741/42 Japan: +81 (0) 33 513 6533 · Korea: +82-31-782-7011 Singapore: +65 6742 6007 · Taiwan: +886-3-5730620 [email protected] ·

© 2011, Charles River Laboratories International, Inc., v.4


Cell Bank Characterization of Mammalian & Other Eukaryotic Cell Lines | Charles River

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