www.criver.com

EVERY STEP OF THE WAY

Mammalian, Insect, Avian, and Other Cell Bank CharacterizationOur experts work closely with clients to develop cost-effective, scientifically sound, validated testing programs for the

characterization of cell banks used to produce biopharmaceutical products. With experience in manufacturing and testing

over 1,500 cell banks, we offer characterization programs that include testing panels designed to detect microbial and viral

contaminants, verify cell line identity, and confirm the genetic stability of cell banks.

Manufacturing and Characterization of a Typical Mammalian Cell BankWeek 3 6 9 12 15 18

BIOLOGIC S TESTING SOLUTIONS

Assay Offerings

• Identity testing

• Sterility testing

• Genetic stability testing

- Copy number determination

- DNA and RNA sequencing

- Restriction endonuclease analysis

• Virological safety testing

Pre-bank testing

Cell Bank production and release - including post-bank viability, B&F, sterility, and mycoplasma

Cell expansion for testing

PBRT

S+L-

Bovine and porcine aventitious agent testing - optional

In vivo adventitious agent testing

MAP and HAP Testing

TEM testing

DNA Barcoding

askcharlesriver@criver.com • www.criver.com © 2017, Charles River Laboratories International, Inc.

Cell Banking Experience

• Mammalian

• Insect

• Avian

• Stem cell

Cell Bank Release and Characterization TestingOur cell bank characterization programs include testing of master cell banks, working cell banks, and end-of-production

cells/cells at limit. We concentrate on developing client-focused project designs tailored to the product, its stage of

development, and the required regulations. A list of assays associated with the characterization of mammalian, insect,

avian, and other cell banks is outlined below. While many of the key aspects of testing are similar across the industry, our

customized programs aim to ensure an appropriate testing plan is developed for our clients’ specific cell lines.

Release and Characterization Testing Available

Detection of Microbial Contamination

Bacteriostasis and fungistasis

Sterility

Mycoplasma (28 day cultivable/non-cultivable assay or PCR assay)

Spiroplasma

Mycobacterium

Detection of Virological Contamination

Transmission electron microscopy

Reverse transcriptase PCR assay (PBRT)

Retroviral infectivity assays

In vitro and in vivo adventitious virus testing

PCR and in vitro assays for specific viruses

Mouse, rat, and hamster antibody production assays

Cell Line Identification and Genetic Stability

Isoenzyme analysis and karyology (optional)

DNA barcoding or other DNA fingerprinting method

Copy number determination

Restriction endonuclease analysis

DNA/RNA sequencing