White paper: 'Virus Testing for Biological Products: Partnering With a Contract Lab'

In manufacturing biological products, there is risk of virus contamination at many levels, from raw materials to processing. This contamination risk means virus testing is required. A proper testing program is essential to ensure the biological product achieves the fastest time to market.

By working with a qualified contract laboratory, the best testing strategy can be executed to assure product safety.

In a new white paper offered by Agawam, Mass.-based MicroTest Labs, Merribeth Morin, Ph.D, Director of Virology at Microtest, reviews the potential sources of contamination, cell bank characterization (virus safety), virus concerns during manufacturing, and ways to effectively partner with a contract testing laboratory.

"When mammalian cell cultures are used for biological products, bovine serum is a raw material that poses a risk for virus contamination," Morin says. "Fetal bovine serum (FBS) has often been used in the culture of cells. As FBS and other bovine serum types are derived directly from cows, there is concern that serum lots could be contaminated when sourced from cows unknowingly infected with virus.

"It is critical that FBS is tested for the presence of a number of different bovine viruses. The Code of Federal Regulations, Animals and Animal Products, Title 9 (9CFR), provides regulations for the testing of serum for bovine viruses. There are seven specific viruses in the regulations, but testing for others can be incorporated into the test when desired. A qualified contract testing supplier can incorporate the additional viruses into the test, as required."

Given the potential difficulty of the process, partnering with a contract lab can provide a great reservoir of resources to draw from, and added expertise.

"The regulatory framework for biological testing can be complex, especially when there is uncertainty on how to proceed," Morin says. "While some manufacturers may have in-house testing capability, often much of the work must be outsourced. Contract testing companies have the expertise to provide the required testing. In selecting a contract testing supplier, it is important to review their capabilities and how they can help with your specific product. Not all products are alike. There may be a general testing strategy for therapeutic products made in a particular cell line; however, this strategy might not be the appropriate testing strategy for your therapeutic product made in a similar cell line."

In addition, if the product is to be marketed in Europe, the requirement for additional testing for contamination by pestiviruses (specifically, Bovine viral diarrhea virus [BVDV]) exists.

To download the entire free white paper, "Virus Testing for Biological Products: Partnering With a Contract Lab," visit www.microtestlabs.com/biopaper

MicroTest Labs Inc.