Paperless validation – Oxymoron, perhaps? Is there really a truly paperless validation solution out there, one that fits the needs of the validation lifecycle? The ISPE Sub-Committee for Paperless Validation has defined ‘Paperless Validation Systems’ as Paperless solutions enable validation lifecycle deliverables to be generated, approved, and more importantly, testing to be completed without...

ISPE’s Women in Pharma^® Hosts a Self Defense and Kickboxing Class at the 2023 ISPE Annual Meeting & Expo.

When discussing manufacturing execution concepts and practices, it is useful to first take a top-down look at life sciences needs and the regulatory/guidance environment.

Pharmaceutical and biopharmaceutical professionals at all levels of the industry gathered in Amsterdam, The Netherlands for the 2023 ISPE Europe Annual Conference to share progress, success stories, best practices, and lessons learned. This year was a major success with a wide range of topics addressing advancements in technology and policy initiatives that are transforming the pharmaceutical...

Novel cell and gene therapies are already revolutionizing medicine. These new therapies can modify a patient's DNA and transform their cells into powerful tools for treating a wide range of diseases, from cystic fibrosis and heart disease to diabetes, hemophilia, and cancer. The introduction of groundbreaking technologies such as CRISPR gene editing has already produced significant...

Since 2013, Thomas Carganico has worked extensively within the pharmaceutical services industries across the US, UK, and Europe. He provides a strong level of experience related to Digital Branding, Marketing & Strategic Communication. He joined the PQE group in 2017 and currently serves as the Vice President of Strategy, Marketing, Communications & Equity Partner. Throughout his...

Welcome fellow ISPE Bio Manufacturing members, sponsors, industry professionals, or those interested in the manufacturing of Cell and Gene Therapies! It is our pleasure to invite you to the 2023 ISPE Biotechnology Conference in Dublin, Ireland. In Track 3 of the conference, we will introduce you to the concept and commercialisation of ATMPs and cell and gene therapy.

Quality Control (QC) is a vital part of CMC (chemistry, manufacturing, and controls), which ensures the quality and consistency of manufactured drug products. It involves a wide variety of analytical technologies, requires well trained analysts, and is a major component of the critical path to regulatory submissions and product release.

This webinar may be for you if you are busy! It is definitely for you if you are everyone’s “go to” person for everything.

Digital Transformation (DT) is impacting every aspect of our personal and professional lives, so it was no surprise that nearly one-third of all presentation proposals for this year’s ISPE Annual Meeting involved DT topics. It is a testament to the breadth of DT that there are three ISPE Communities of Practice (CoPs) operating in this space, each of whom had submitted high-quality...

The ISPE Drug Shortages Initiative Team conducted a webinar on 9 February 2023 to discuss regulatory and industry insights on drug shortage prevention with a focus on the Asia-Pacific region. The webinar was moderated by Vivien Santillan, Regional Director, Asia, Novatek International. Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the...

Following the recent surge in popularity of mRNA technology due to Covid-19 vaccines, we are beginning to realise its impact and potential in this field and for oligonucleotides. However, we face a steep learning curve in understanding the diversity and specifics of the manufacturing chain that make this new generation of RNA drug products completely different from traditional biologics (e.g....

Digital initiatives are becoming increasingly abundant and important, but many large organizations, particularly in the life science sector, struggle to implement and roll out these initiatives successfully. A common reason for this is that digital transformation efforts often fail to successfully move from the boardroom to the plant room, resulting in a disjointed user experience with limited...

The ISPE GAMP^® Blockchain Special Interest Group is excited to be in its 4th year! For those of you following this space I’m sure you can appreciate the roller coaster of events across crypto, blockchain, and pharma over that time. Yet despite many of the external challenges the core technology behind blockchains has remained secure, available, and immutable – just as they were...

Are you interested in developing a new bioproduct and attracted by the incredible potentials of new modalities like ATMPs, Cell and Gene Therapies, AAVs, oligonucleotides, multi-specificity antibodies, mRNA vaccines, and more? Despite the appeal of these new modalities, there is a significant risk of failure due to the many unknowns associated with these new technologies.

The needs of patients provide the impetus to challenge the notion of “this is the way we’ve always done it.”

Speed to market is a major priority for life sciences companies and this is going to be a featured topic during the 2023 ISPE Biotechnology Conference. More than ever before, biotechnology companies are pushing for exponential growth by expediting the scalability of manufacturing processes and the use of different modalities. This can significantly accelerate patient access to life-saving...

Industries around the world are working to reach carbon neutrality. By reducing greenhouse gas emissions or removing carbon dioxide from the atmosphere, companies can effectively make up for the emissions they produce elsewhere. Think of it like planting a tree in one place for every tree you cut down elsewhere. In theory, if you plant as many trees as you cut down, you will reach “net-zero...