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ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.  

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iSpeak Blog

I have been active in ISPE for many, many years, but when I attended my first ISPE Pharma 4.0™ and Annex 1 Conference in Manchester back in 2019, I was surprised by how few people I knew. I realized that my network within ISPE was very much focussed on Aseptic, Manufacturing, and Quality, and not so much on Digitalization and Pharma 4.0™.

iSpeak Blog

The global pharmaceutical industry has faced unprecedented challenges in recent years, with the COVID-19 pandemic serving as a wake-up call for the vulnerabilities within the pharmaceutical supply chain. As the world strives to emerge from the grip of the pandemic and restore activities reminiscent of pre-pandemic times, uncertainties surrounding supply chain stability persist. The

iSpeak Blog

The 2023 Europe Hackathon was the largest and most successful one yet. 36 Emerging Leaders from 12 countries descended on Amsterdam, the Netherlands on the weekend preceding the 2023 ISPE Europe Annual Conference to formulate their creative solutions to a real-world pharmaceutical manufacturing challenge.

iSpeak Blog

The Smart Industry Readiness Index (SIRI) is a valuable framework that serves as a solid foundation for the Life Sciences 4.0 journey in Pharma, Biopharma, and Medical Devices manufacturing plants. However, it does have its own shortcomings. This blog presents our point of view, covering the strengths and weaknesses of the SIRI framework, and suggests a potential way forward to complement its...

iSpeak Blog

With over 30 years of successful leadership experience in human asset development, building and sustaining operations activity, new project builds, project management, merchandising and new start-up sales/operational fundamentals, Jim Hubbard brings a wealth of experience to ISPE.

iSpeak Blog

ISPE’s Women in Pharma®  group advocates for accelerated equality in the pharmaceutical industry and beyond. Through virtual and in-person programming, Women in Pharma provides ISPE members the resources necessary to challenge the status quo and make an impact on both a personal and professional level.

This summer has been, and will continue to be, quite busy with...

iSpeak Blog

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...

iSpeak Blog

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...

iSpeak Blog

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...

iSpeak Blog

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...

iSpeak Blog

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.

iSpeak Blog

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.