ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues, or cells. This class of products cannot be terminally sterilized and, in many cases, cannot be filtered and are manufactured by Aseptic processing. The increase in demand for these life-changing products has been fraught with technical and regulatory challenges as laboratory processes are scaled to commercial...
ISPE’s Pharma 4.0™ Baseline Guide authoring team received the prestigious Committee of the Year Award, as part of the 2024 ISPE International Honor Awards which were presented at this year’s 2024 ISPE Annual Meeting & Expo., The Committee of the Year Award recognized the Pharma 4.0™ Baseline Guide Authoring Team for their...
The pharmaceutical industry is undergoing a remarkable transformation, with advanced modalities like antibody-drug conjugates (ADCs) and radiopharmaceuticals driving the evolution of precision medicine. These innovations are not only redefining drug development but are also improving patient outcomes through targeted therapies, reduced side effects, and expanded treatment options. The...
On 16 October at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, USA, Emer Cooke, European Medicines Agency (EMA) Executive Director and chair of the International Coalition of Medicines...
In this blog post, Charlie Wakeham, Director of WakeUp to Quality and Chair of the ISPE GAMP® Global Steering Committee, shares a recap of the ISPE Australasia Digital Innovation Conference, which took place 24 – 25 September 2024.
All economic sectors, including life sciences, are undergoing a significant transformation driven by the increasing focus on integrating environmental, social, and governance (ESG) criteria into their strategies and activities. This shift is crucial as companies face growing pressures from stakeholders such as customers, regulators, suppliers, and employees to act responsibly and...
Designing a monoclonal antibody (mAbs) production facility presents a series of unique challenges, balancing regulatory compliance, efficiency, sustainability and flexibility. Through careful planning and design, companies can create production environments that meet growing demands while optimizing operational efficiency.
From Student to Leader: Paul Quizon’s Journey in Pharmaceutical Engineering
For students and recent graduates venturing into the pharmaceutical world, Paul Marvin Quizon’s story serves as an inspiring guide. From starting out as a graduate student at the University of the Philippines Manila, Quizon’s journey through academia, industry, and eventually to a leadership role within ISPE...
The pharmaceutical manufacturing landscape is becoming increasingly complex, especially with new regulations and technological advancements. One of the most significant challenges facing the industry today is the implementation of Annex 1, which focuses on the manufacture of sterile medicinal products. The 2024 ISPE Pharma 4.0™ and Annex 1 Conference...
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee is thrilled to announce a valuable series of blog posts, where its committee members dive into the validation and use of essential equipment and processes that drive sterile processing in the pharmaceutical industry. Planned blog posts include:
As the pharmaceutical industry navigates the complexities of digital transformation, the concept of Pharma 4.0™ emerges as a pivotal framework for integrating advanced technologies into business processes. The upcoming 2024 ISPE Pharma 4.0™ and Annex 1 Conference,...
At the 2024 ISPE Annual Meeting & Expo held in Orlando, Florida, USA, in October, a panel of global regulators and industry professionals addressed harmonization and regulatory convergence, digitalization, particularly the use of artificial intelligence (AI), and supply chain resilience.
At the 2024 ISPE Annual Meeting & Expo, held 13-16 October in Orlando, Florida, USA Nina Cauchon, PhD, Director, Regulatory Affairs -- CMC, Amgen, led a session on the global adoption status and implementation strategies for recent International Council on Harmonization (ICH) guidelines
Theresa Mullin, PhD, Associate Director for Strategic Initiatives at the US Food and Drug Administration’s (US FDA) Center for Drug Evaluation and Research (CDER), opened the 2024 ISPE Meeting & Expo in...
The 2025 ISPE Aseptic Conference, taking place 17 – 18 March 2025 in Washington, D.C., USA, has always been one of the more future-focused technical conferences within ISPE. Originally called the ISPE Barrier...
In an era where technological advancements are reshaping every industry, the pharmaceutical sector is no exception. The 2024 ISPE Pharma 4.0™ and Annex 1 Conference is the gateway to understanding...
In an increasingly complex world, where the reliable delivery of power from point A to point B often depends on substantial construction and upgrade activities, the need for efficient project delivery has never been more critical. For manufacturers, completing pharma facility and process optimization projects quickly and cost-effectively can be challenging. As a result, many are exploring new...
