Articles

The topic of continuous manufacturing has drawn considerable interest across all modalities of pharmaceutical manufacturing. Thus far much of the progress has been seen in small molecule drug product manufacturing platforms where multiple products have...

The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing Practice (GMP) regulations...

Example case studies show how the evolution of advanced analytics enables innovation in pharma.

Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfers the knowledge to a different...

When we first launched the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) in 2017, we benefited from an incredible enthusiasm and engagement from across the ecosystem. At the time, academic institutions were working to...

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

Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. Chris Smalley,...

Soon we’ll be gathering on a virtual scale with all our biotech colleagues in ISPE. Never daunted by the challenge of the pandemic, ISPE went right to work on this conference once the crisis hit. This is my fifth conference on the planning group, and I...

COVID-19 pandemic has caused unprecedented change and disruption to each of our daily lives. All of us around the world are touched by the current pandemic, whether it be personal hardship or professional life challenges. We have seen our communities and...

You’ve been with ISPE for 18 years and currently serve as Chair of the ISPE France Affiliate. Can you share some of the highlights of your involvement with the Society during your tenure? During this period, I’ve experienced many highlights! Among them,...

In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and...

COVID-19 pandemic has caused unprecedented change and disruption to each of our daily lives. All of us around the world are touched by the current pandemic, whether it be personal hardship or professional life challenges. We have seen our communities and...

COVID-19 pandemic has caused unprecedented change and disruption to each of our daily lives. All of us around the world are touched by the current pandemic, whether it be personal hardship or professional life challenges. We have seen our communities and...

COVID-19 pandemic has caused unprecedented change and disruption to each of our daily lives. All of us around the world are touched by the current pandemic, whether it be personal hardship or professional life challenges. We have seen our communities and...

COVID-19 pandemic has caused unprecedented change and disruption to each of our daily lives. All of us around the world are touched by the current pandemic, whether it be personal hardship or professional life challenges. We have seen our communities and...

ISPE is dedicated to keeping our members up to date on the latest news and resources about COVID-19 and the ways the pharmaceutical industry is adapting to ongoing developments. One valuable resource is the Food and Drug Administration’s (FDA)...

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

The spectrum of gene therapy with some specificity to viral vectors is very broad including both delivery vehicles developed for transient short-term and permanent long-term expression. Moreover, the types of vectors are represented by both RNA and DNA...

Commercially available Advanced Therapy Medicinal Products (ATMPs) are now a reality and significant, rapid growth is expected for new treatments and applications in the clinical development pipeline. By some estimates, from 2014 to 2018, the number of...

I’ve been involved in Women in Pharma at ISPE since its inception. I’ve been a proud supporter and contributor to the group. Today, more than ever, I have an unwavering belief that this group is invaluable. In light of the recent COVID-19 crisis that has...

We are in a current state that leaves us at home, or likely with a bit more time on our hands that may be of help to our Women in Pharma® initiative at ISPE.  We are getting creative on how to keep our membership engaged and would greatly appreciate your...