iSpeak Blog

September 24, 2018
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...
September 20, 2018
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...
September 12, 2018
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...
September 10, 2018
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...
September 06, 2018
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...
August 29, 2018
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...
August 27, 2018
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...
August 24, 2018
Shire is the 2018 FOYA Facility Integration Category Winner for their Los Angeles Master Plan Building 8 Project in Los Angeles, California. Winners in this category exemplify the application of good design practices and superior conceptual planning...
August 22, 2018
Overall Equipment Effectiveness (OEE) is a key metric for Packaging Operations. When used well, it can help determine the effect of continuous improvement and when it is the right time to add new capacity or replace existing equipment. It is not surp...
August 21, 2018
ISPE’s Facility of the Year Awards (FOYA) program recognizes the shared commitment and dedication of companies worldwide, to enhance patient health and safety through innovation and advancement. “The FOYA Award is important [to the] industry as a who...