Articles

United Therapeutics is the 2020 Facility of the Year Award Winner for Social Impact for their Dinutuximab-Dedicated Oncology Medical and Analytical Laboratory in Silver Spring, Maryland.

Bristol-Myers Squibb is the 2020 Facility of the Year Award Winner for Project Execution for their Multi-Purpose Cell Culture (MPCC) in Cruiserath, County Dublin, Ireland.

Janssen Pharmaceuticals is the 2020 Facility of the Year Award Winner for Process Innovation for their Mirror 1: A Continuous Manufacturing Platform in Beerse, Belgium.

Eli Lilly and Company is the 2020 FOYA Category Winner for Operational Excellence for their Lilly Innovation Development Center in Indianapolis, Indiana.

There is a real advantage in opening up and confiding in someone. Being vulnerable can be a superpower, but it does not mean that you should trust everyone with everything. It also does not mean that you should always emotionally charged break downs....

Sanofi is the 2020 Facility of the Year Award Winner for Facility of the Future for their Sanofi Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham, Massachusetts.

Pfizer, Inc. is the 2020 Facility of the Year Award Winner for Facility Integration for their Andover Clinical Manufacturing Facility (ACMF) in Andover, Massachusetts.

F. Hoffmann-La Roche Ltd. is the 2020 Facility of the Year Award Category Winner for Equipment Innovation for their B098: Setting the new standards for an in vivo building in Basel, Switzerland.

When Women in Pharma® (WIP) at ISPE was first launched at the 2016 Annual Meeting in Atlanta, it was after a few previous attempts mainly as a female-centric gathering. In Atlanta, we officially started talking about the professional issues that are...

What are the Short & Long-term Challenges that Pharma Supply Chain, Operations, and Packaging Need to Address? In a year where speed has become a critical component of the pharmaceutical industry’s mission, the SCOPE track at the 2020 ISPE Annual...

The environmental impact of “single-use plastics” has become a hot topic of societal and political debate. Despite the many technological advantages and innovations that plastic has enabled, it is now under closer scrutiny, especially those massively...

Process validation (PV) aims at reassuring a manufacturer of constant product quality. Moreover, it is a regulatory requirement to achieve licensure of a pharmaceutical product Failing to efficiently plan and execute activities here leads to increased...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from September 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...

The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry representatives, for industry use, to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of...

The needs of patients must always be at the forefront of what we do.

Aren't you amazed about how fast the world has come together to find a collective solution for COVID-19? We have learned in the past months that we can compress the traditional vaccine paradigm, which is between 5 to 10 years to just 4 to 18...

Agile Software Development in GxP Regulated Environments GAMP® Special Interest Group User Requirements (Specification) Successful delivery requires ensuring we build the right system that is fit for the intended use, not just ensuring we build the...

Victor CF DiChiara Retired Wow! You have been with the Society for 40 years! Can you give me a brief summary of your involvement with ISPE and share...

ISPE was selected as one of a limited number of focused stakeholders to provide comments on nine questions posed by PIC/S on the draft GMP Guide Annexes 2A for Advanced Therapy Medicinal Products (ATMPs) and 2B for Biological Medicinal Substances. ISPE...

A committee under the auspices of the National Academies of Sciences, Engineering, and Medicine (NASEM) is conducting a study with the aim of producing a consensus report that identifies emerging and upcoming technologies that have the potential to...

In response to the COVID-19 pandemic, several governments are considering legislation or regulatory actions that would require some or all parts of a drug product’s supply chain, e.g., Active Pharmaceutical Ingredients (APIs) and biotherapeutic drug...