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 conjugates...

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...

The Trend Supply chains that span the globe can be challenging to monitor, leaving opportunities for error and diversions. As manufacturers around the world strive to maintain – and improve – safety in an increasing globalized supply chain,...

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...

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...

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 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 not...

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 fascinating...

  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...

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...

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...

Process characterization is an essential step in the commercialization of a new (biological-) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures, that the manufacturing process delivers...

The Product Development & Product Systems Track at the 2018 ISPE Annual Meeting & Expo The pharmaceutical industry is coming out with new product and therapeutic innovations at a rapid pace. For example, cell and gene therapy is one of the...

We are surrounded by branding every day, influencing how we buy for our food, cars, and drugs. When you buy your medication, do you buy a brand-name or a generic? According to the FDA, a generic drug is a medication created to be the same as an existing...

When the human genome was fully mapped in 2003, a futuristic concept of personalized medicine materialized. Medicine based on a person’s unique genetic make-up was not just a holy grail, now it was a REAL possibility. Over the past 15 years,...

Kinza Hussain MCPHS Student Tell us a little about yourself – what year you are in at MCPHS, what is your major, and what attracted you to that major? I am a recent Bachelor of Science graduate from Massachusetts College of Pharmacy and Health...

The End-to-End Supply Chain Track at the 2018 ISPE Annual Meeting & Expo Excellence in pharmaceutical supply chain performance is a key to creating “Reality from the Vision”. At the 2018 ISPE Annual Meeting & Expo, we will hear from two...