ISPE Women in Pharma^®’s dedication to diversity, equity, and Inclusion isn't just about aspirations: it’s about action. Mentor ISPE, launched in 2023 by members for members, is a testament to this commitment. Over the past two years, more than 700 professionals from around the world have joined ISPE on this journey, and as Mentor ISPE approaches its third year, the team invites ISPE...

The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the latest trends, technologies, and best practices shaping the future of pharmaceutical engineering. This year, 13-16 October in Orlando, Florida, USA, ISPE has curated a diverse...

Miriam Kremer-van der Kamp is the Business Developer at VILS Switzerland GmbH and an active ISPE member with the ISPE Germany/Austria/Switzerland (DACH) Affiliate, ISPE Women in Pharma, and ISPE Emerging Leaders. In this interview, conducted by Edyna Miguez, Membership Growth Manager at ISPE, Kremer-van der Kamp weighs in on why she joined ISPE, the benefits she’s experienced thus far, and...

What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to do with each other?

At the 2024 ISPE Biotechnology Conference, held in Boston, Massachusetts, USA, in June, Sharmista Chatterjee, PhD, director of the US Food and Drug Administration’s (US FDA) Division of Pharmaceutical Manufacturing Assessment III, Office of Pharmaceutical Quality (OPQ), Center...

As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more crucial than ever. The 2024 ISPE Annual Meeting & Expo, set to take place from 13 - 16 October in Orlando, Florida, USA and virtually is the opportunity to connect, collaborate, and lead in this dynamic landscape. This year’s event promises to be the most impactful yet, offering an unparalleled...

As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry leaders is more crucial than ever. The 2024 ISPE Annual Meeting & Expo, 13-16 October in Orlando, Florida, USA and virtually offers a unique platform to gain insights, enhance your professional development, and network with the brightest minds in the field. This event is designed to empower...

Pharmaceutical Engineering® (PE) is delighted to announce the finalists for the 2023 Roger F. Sherwood Article of the Year Award. The articles were selected by judges from 39 feature and technical articles published in PE during calendar year 2023 (Volume 43).

In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry: Process Validation: General Principles and Practices.”1 The document incorporated...

We are excited about the 2024 ISPE Annual Meeting & Expo in Orlando, Florida! A special thank you to the sponsors and planning committee for the Hackathon. We appreciate your commitment to ensuring that recent graduates and college students will benefit from this challenging and...

In the dynamic realm of regulatory affairs, a significant transformation is unfolding—a movement that empowers women to assume pivotal roles in decision-making, policy formulation, and leadership.

I hope everyone had the opportunity to enjoy the summer. The ISPE International Board of Directors and ISPE staff have kept busy through the summer months, launching two new Communities of Practice: Sustainability and Artificial Intelligence.

Computer software assurance (CSA) has been discussed widely in industry over the past five years. While the principles are well understood and welcomed, until now some of the practical detail on how exactly to implement CSA into an organization has been missing.

Cell and gene therapy (C&GT) products address various diseases at the cellular or genetic level, offer innovative treatment approaches, and represent a significant advancement in the field of medicine. However, developers of C&GT products face unique challenges due to their complexity, such as establishing assays that show a clear link between potency, mechanism of action (MoA), and...

After completing her doctoral degree at Oklahoma State University, Sarah Pope Miksinski received a fellowship at the National Institutes of Health. While working there, she realized that research was not the best career path for her.

Anil Mathai first heard about ISPE 30 years ago. “I attended Drexel University, where you are required to complete three cooperative education jobs. One of mine was for Rhône-Poulenc Rorer, Inc. in Collegeville, Pennsylvania. While I was there, I learned about validation and decided that I wanted to be in pharmaceuticals as a chemical engineer.”

In 2023, ISPE launched an expansive and significant initiative, Enabling Global Pharmaceutical Innovation: Delivering for Patients, to address the barriers to technological innovation in the pharmaceutical industry. The first activity of the initiative was to conduct a three-part survey of ISPE members to understand the circumstances and confirm the sources that create barriers to...

In each issue of Pharmaceutical Engineering^®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Wendy McGhee, Health Authority Outreach Manager in the Regulatory Operations group.

Drug delivery devices have become an essential component for many modern medical therapies, and it’s vital that they function as intended. However, the reality of marketed products shows that this is not always achieved because drug-device combination products are becoming increasingly complex, with an increasing number of potential failure modes. Significant challenges for engineers include...

ISPE’s regulatory initiatives and programs bring visibility and solutions to significant regulatory and quality challenges faced by the industry, facilitate the flow of information between ISPE members and global health authorities to find solutions, and promote interaction between regulatory bodies in the interests of harmonization.

Pharma Manufacturing Co., Ltd. has been awarded the 2024 ISPE FOYA Category Winner for Social Impact. This recognition highlights their exceptional work on the UK4 project, a biological drug substance manufacturing facility designed and built under the...

The 2025 Facilities of the Future Conference will explore innovations in facility design and delivery, emerging trends in technologies, manufacturing, and support areas such as laboratories and warehousing. Also included are the ways technology and digital...

In celebration of International Women’s Month, ISPE Philippines Affiliate hosted an evening of networking dubbed Women in Pharma® Soiree – An Evening of Celebration and Conversation, held 22 March 2024 at the Westgate Filinvest City. The dinner and networking event was organized by the ISPE Philippines Affiliate Women in Pharma® core team led by its Chair, Jayvee Lalusis, MD. The event aligned...