During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. This article focuses on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help you dodge the COVID-19 bullet.
BioProcess Online is proud to launch The Business Of Biotech, a podcast series dedicated to the leaders of new and emerging biopharma firms as a resource on their journey from drug discovery to success in the clinic. Here's a preview of our first season, stacked with insight from founders who have done just that.
Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.
As cell therapies move toward commercial production through scale up and multiple capacity increases, we as an industry have not come to grips with how to reliably and economically provide the needed capacity within the open manual processes that we have been working with for many years.
With the FDA guidance documents and requirements of the Drug Supply Chain Security Act still unfolding, there is a growing need for sectors in the supply chain to align on how to meet various aspects of the law.
There is a regulatory grey area between healthcare and consumer health products, often causing confusion for brands entering this space. The microbiome is one area that is bringing new challenges, because much of the science supporting microbiome product claims are very new and remain unproven in many cases.
This article is the second in a two-part series explaining how to successfully harmonize disparate quality systems when two companies combine. Part 1 shared horror stories — drawn from the author’s experiences — illustrating what NOT to do during each phase of QMS harmonization. Here in Part 2, we look at case studies in which companies got it right, bringing together parallel quality systems in a way that increased the probability of success.
This article examines the nature of comparative efficacy testing and suggests that these studies may be providing misleading evidence of safety and efficacy of biosimilars and should be replaced with more objective pharmacokinetic studies.
Jennifer Jones Paton and her teams at the Colorado BioScience Association and Colorado Bioscience Institute are leading a unique education-based approach to the long-term sustenance of a fast-growing bioscience hub in the Mountain states.