A structured approach to problem solving using quality risk management (QRM) techniques can aid in the development and implementation of action plans and knowledge transfer programs to ensure the production of safe and effective drug products in times of staff shortages related to the COVID-19 pandemic.
It may be time to consider eliminating the use of the traditional risk priority number (RPN) score and transitioning to the use of action priority (AP) ratings. AP ratings are much simpler to use, do not require a calculation (eliminating the validation of a spreadsheet), and provides a single simple table reference to determine the appropriate level of action.
Biotechs are surging in Chile, fertilized by a deep academic foundation, ample funding, plentiful low-cost laboratory space, and a collaborative global research environment. We caught up with Cristian Hernandez-Cuevas, the man behind the mission.
COVID-19 has caused an increase in demand for APIs and drugs; those used as antimalarials are seeing the highest demand, followed by bronchodilators, antibiotics, and antivirals. This article reviews the drugs and API in demand globally, with assessments of their supply status in India and China.
As of March 23, 2020, insulin now falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This regulatory shift presents both new opportunities and new obstacles for developers of follow-on insulin products.
Few of us have ever lived with so much uncertainty and lack of knowledge as we are facing now. This article explains why a structured approach for making risk-based decisions is so important, particularly when we find ourselves in stressful conditions with conflicting needs on many fronts.
We just launched the first full episode of the Business of Biotech podcast, a series purpose-built for the leaders of new and emerging biopharma companies. Here’s a recap of the first episode with industry icon Allan Shaw, highlighting the season to come and offering some strategic, straightforward advice for new biopharma leaders.
More than 100 non-COVID-19 trials have been put on hold, and only 14 percent of sites are open for enrollment. This dynamic forces an evaluation of the regulatory impacts our industry faces in the wake of COVID-19 and what to expect in the months ahead.
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.