Facilities and Equipment


Moving platforms from development to the delivery of more biopharmaceuticals to more patients is reality, not just a concept, for Moderna, Inc. Juan Andres, the company’s Chief Technical Operations and Quality Officer, presented on “mRNA Medicines—Industrializing a New Platform” at the


Although other industry publications have explored the effect of surface finish on biofilm formation, background data indicating that imperfections exceeding the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) standard are detrimental to chemical cleaning performance are lacking.1

  • 1Arnold, J. W., and O. Suzuki. “E ects of Corrosive Treatment on...

Although it includes some background material, this article is based predominantly on a series of interviews with SMEs at Eli Lilly, Janssen, Hovione, C-SOPS, and Patheon from October to December 2017. The comments and observations that follow are theirs.


Janssen is in the midst of a multimillion-dollar expansion project at the company’s Ringaskiddy, County Cork, manufacturing facility in Ireland. The 19,100-square-meter project is expected to significantly increase Janssen’s global manufacturing capacity for producing biologic medicines for multiple myeloma, rheumatoid arthritis, and Crohn’s disease.


A wide range of pharmaceutical products is produced using two complex fermentation processes. Anaerobic fermentation takes place in the absence of oxygen, and aerobic fermentation requires oxygen, supplied via blower and compressor systems, to yield microorganisms and produce the desired product. This article examines the role of aeration equipment in aerobic fermentation, considerations when...

This highly interactive pre-recorded online course reviews the Facilities and Equipment Systems and their importance within the USFDA Systems Inspection . The Facilities System elements examine the general regulations...