iSpeak Blog

With less than a month to go, we are now working with our industry and regulatory colleagues to finalize the sessions for the Quality Systems and Regulatory Track for the 2018 ISPE Annual Meeting & Expo . The program is looking fantastic. We kick off...

By the year 2025, every second new biopharmaceutical product will be considered highly potent and/or toxic with the oncology sector driving the growth. Highly potent/toxic products are a new generation of combined products like antibody drug conjugat...

David W. McAlonan, BSChE, MBA Retired Retired Dave McAlonan joined ISPE in 1988 and recently retired from AbbVie, formerly Abbott Labs. Dave has been a Great Lakes Chapter leader and has served on the North America South America Affiliate Council and...

Have you tried designing an ATMP manufacturing facility and found the lack of regulatory guidance challenging and even frustrating. I recently had such an experience. Advanced Therapy Medicinal Products (ATMPs) are new state of the art therapies that...

BioMarin Pharmaceuticals is the 2018 Facility of the Year ® Project Execution Category Winner for their Project FAITH site in Novato, CA. Projects selected in this category exemplify the application of novel tools and approaches to delivering project...

New terms in the biopharma realm rarely surprise us but keeping up with the technology and the means of manufacturing can often be challenging. What I really enjoy about ISPE is the way they bring these new technologies to life allowing us to learn f...

Facilities and Equipment is a very broad track intended to challenge those involved in the delivery of pharmaceutical facilities used to support the development, manufacturing, testing, and storage of pharmaceutical industry products meeting quality...

2018 ISPE Continuous Manufacturing Workshop A group of global consortia have given new meaning to the term “collaboration” in the pharma industry. Populated by academia and industry, and increasingly governments and regulators, consortia work togethe...

2018 ISPE Continuous Manufacturing Workshop Disclaimer: This article contains brief, abridged, and informal synopses of remarks from a US FDA regulator during the 2018 ISPE Continuous Manufacturing Workshop proceedings in June 2018. This content has...

If you want to prepare yourself for the next 10 years of your career, then I invite you to join me at this year's 2018 ISPE Biopharmaceutical Manufacturing Conference , 10 -12 December, Huntington Beach, California, a conference focused on a fascinat...