ISPE Bio Event Examines Approaches for Optimizing Operational Agility and Time-to-Launch Readiness
The International Society for Pharmaceutical Engineering (ISPE) introduced its Biopharmaceutical Manufacturing Conference, happening December 4–6, 2017 in San Francisco, California.
The International Society for Pharmaceutical Engineering (ISPE) revealed its Biopharmaceutical Manufacturing Conference, happening December 4–6, 2017 in San Francisco, CA. The event will focus on optimizing operational and process development approaches to improve speed-of-launch readiness.
“As companies prepare for the increased demand for facility improvements, design, and manufacturing resources, operational agility and faster time-to-launch readiness are two key factors that will have an impact on their success,” stated ISPE CEO and President John Bournas.
The conference will include keynote speakers from organizations such as BioMarin, Kite Pharma, FDA, Avara, and Gilead Sciences. Additionally, three educational courses, complete with informative sessions, will provide attendees insight from industry, supervisory, and academic specialists.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
