By R. Carbonell, A. Mukherjee, J. Dordick, and C. Roberts
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has published technology roadmaps addressing needs and gaps in three key product areas: gene therapy, antibody-drug conjugates, and vaccines. The roadmaps were developed with the collaborative input of industry, academic, and government experts.
By Mark Vessely, BGC Engineering, Inc., and Christina Vessely, Biologics Consulting, Inc.
Natural hazard events may seem like distant topics to some in the biopharmaceutical industry, but they hold relevance for all companies. Opportunities exist for risk management, including an important lesson in avoiding the gradual acceptance of such events as normal, until an even greater catastrophic event occurs.
The LAL (or Limulus) test is used for the determination of bacterial endotoxins in a wide variety of samples. In this article, the biological process and the way it was used to develop the test is described.
This Q&A outlines the use of Amsphere A3 resin to purify antibody fragments, explains the molecular binding mechanism for VHH single-domain antibodies, and compares dynamic binding capacity data with those of other affinity resins.