Catherine Shaffer is a contributing writer to BioPharm International, cathshaffer@gmail.com.

Catherine Shaffer

Contamination with microbes, mycoplasma, viruses, and adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can occur from many sources, raw materials are the most significant source of contamination. 

	Strategies for preventing contamination including upfront testing of materials, barrier disinfection methods, and adhering to best practices in processing and sanitation are explored.

	Avoidance of animal-based raw materials, as well as careful sourcing of any materials used, are discussed.

Articles

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

Ensuring the Biological Integrity of Raw Materials

The approval of biosimilars for the US market has created a need for more efficient manufacturing processes.

	Manufacturers are developing processes for cost efficiency and reliability using newer technology to compete with innovator products manufactured with legacy processes.

	Innovations include more productive cell lines, single-use systems, and powerful analytical methods.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.