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).

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...

The unstoppable progress in technology and scientific knowledge is reshaping our industry. It is delivering novel treatments for patients and digitized monitoring tools for healthcare professionals; improved operational efficiency, less waste, and resource conservation for industry; and greater connectivity for risk-based regulation.

The landscape of clinical trials has evolved significantly with the pandemic and interest in utilization of decentralized clinical trial (DCT) designs as a mitigation and the need for remote data collection. In response to this shift, the US Food and Drug Administration (US FDA) has released draft guidelines to try to provide clarity on the use of DCT models in clinical trials. While the...

The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of medicines requires the close collaboration with regulators, emphasizing innovation, partnership, and a continued dedication to addressing patient needs. This transformation holds the potential to guide significant advancements in the development and delivery of medicines, leading to improved...

Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with thousands of therapies currently in various stages of pre-clinical and clinical development.

The pharmaceutical industry stands at the cusp of a transformative era, where the integration of sustainability within the supply chain is not just a trend, but a necessity. The 2024 ISPE Annual Meeting &...

Although parenteral products make up only 1% of global pharmaceutical prescriptions by volume, at list price they now make up nearly half of global sales value, a percentage that has been increasing. Many of these are complex products produced in smaller batches for immunology or oncology, and a large majority are biologic therapies, which are generally poorly suited to oral formulations.

In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of asset management programs at each company. The initial sessions were a success, covering topics such as asset condition evaluations and asset management governance. CSL was keen to continue the conversations and gather more insights on certain...

Pfizer Asia Pacific Manufacturing Ltd has been honored with the 2024 ISPE Facility of the Year Award (FOYA) Category Award Operations in Project Execution. This prestigious award recognizes the outstanding efforts behind the Pfizer API Facility Extension, commonly referred to as Tuas 2, located in Tuas, Singapore.

As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...