Manufacturers, suppliers, and regulators have recognized that introducing new technologies also introduces a degree of unfamiliarity and uncertainty.
Testing for evidence of microbial contamination in bioprocessing has a long history — and can be expensive, slow, and burdensome. So suppliers, testing facilities, and regulators have been seeking improvements.
As the gene and cell therapy sector develops and its products start to move from development to commercial manufacture — from smaller or academic establishments and development laboratories to larger facilities with greater capacity — the requirement for the technology transfer of these products will only increase.
FY2017 saw another year of increase in the number of drug GMP warning letters issued by the FDA, though not as dramatic a difference as between FY2015 and FY2016. This article presents a detailed summary of those warning letters, as well as a comparison of trends since fiscal year 2013.
The watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, has filed a lawsuit against the FDA for denial of CRS’ citizen petition, which was originally submitted in June 2014 and has since had several amendments.
In recent years, we’ve seen a rise in regulatory concern over adequately determining the risk factors that challenge aseptic and sterile products processing. There needs to be a renewed emphasis on assurance and controls, including leveraging the best available technologies and conducting thorough, science-based risk assessments of processes.
This article explores some of the policy changes happening now in the regulatory rare disease space as the FDA’s leadership team implements these changes at the agency.
Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?
The Orphan Drug Act of 1983 (ODA) has been wildly successful in its primary goal of spurring innovation that has led to lifesaving therapies. Unfortunately, the design of the ODA and several of the incentives the act provides have led to a host of unintended consequences.
Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.