05.13.21 Biopharma Cold Chain Logistics 101
Life sciences companies face major challenges to continued operations and profitability including patent expirations, low R&D productivity, increased competition, decreased margins, nonoptimized processes, and mounting compliance pressure. Join us on May 25, 2021 at 11:00 a.m. EDT, to understand the technologies needed to meet today’s requirements, how to spend more time on science and less time correcting data, and how to improve efficiencies in process development, collaboration, and product quality.
By Curtis Gippe, Adept Packaging
Cold chain logistics can be complex and intricate. Maintaining the integrity of controlled-temperature products requires holistic consistency between design and development, manufacturing and packaging, qualification and validation, cold storage, transportation, and monitoring as the product moves from its point of origin to the end user.
01.26.21 Top 10 Most-Cited MHRA GMP Inspection Deficiencies
Continuing our Cell & Gene series,
Business of Biotech features Dr. Bobby Gaspar, Orchard Therapeutics CEO, speaking on the challenges his company faces in the production of hematopoietic stem cells to treat neurometabolic disorders, primary immune deficiencies, and blood disorders. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Barbara Unger, Unger Consulting Inc.
In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019 and addressed the critical and major deficiencies and the annexes and chapters with which they are associated. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.