Biologics Manufacturing Articles and Resources

Latest Articles

A Guide to Common Sterile Processing Contaminants

Cleanroom Technology Feb. 22 article: we will explore a handful of common bioreactors and cleanroom organisms in terms of why they are able to proliferate and persist despite thorough Quality by Design (QbD) developed methods of production.

What the Heck is a Mycoplasma and Why Doesn’t Anyone Like Them?

The global bioburden testing market for bio-pharma contamination is approximately $10B, with over 350M tests run annually. LexaGene provides early detection for mycoplasma, aiding in validating product quality for biopharmaceutical manufacturers.

Building Screening and Surveillance Confidence in Bioprocessing

Single-use manufacturing has provided for a large degree of flexibility in terms of production volumes but have also brought about efficiencies in sterility control by reducing hands on cleaning and sterilization necessary for stainless steel.

Latest Resources

January 18, 2022
In this study, slow-growing bacterium and typical contaminant, C. acnes, was challenged for microbial detection utilizing both LexaGene’s MiQLab System and anaerobic culture.

December 1, 2021
Rapid At-Line Screening Solution for Microbial Contamination Control

November 18, 2021
With the advancement of technologies such as CRISPR and CAR-T therapies, there has been a significant increase in the development and production of biologic drugs, Advanced Therapeutic Medicinal Products (ATMP) and Cell and Gene Therapies (CGT).

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