ISPE’s Q12 Implementation Team continued its series of training events with a well-attended course for Singapore’s Health Sciences Authority (HSA) in November.

The Dr. Antonio Moreira Memorial Professional Development Fund was established in 2024 in honor of Dr. Moreira, a former Chair of the ISPE Foundation Board of Directors who passed away that same year. As a 20-year member of ISPE, he was a dedicated leader who consistently championed the ISPE Foundation and tirelessly promoted the importance of student development and engagement.

Niranjan S. Kulkarni, PhD, was honored with the ISPE Max Seales Yonker Member of the Year Award at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, US.

ISPE has launched a new feature on ISPE Engage, providing members with a portal to explore volunteer opportunities across the organization.

The ISPE Commissioning & Qualification (C&Q) Community of Practice (CoP) conducted a survey in 2023 on the adoption of integrated C&Q, specifically on the use of paperless digital systems for planning, executing, and reporting C&Q activities. The survey revealed that 74% of respondents planned to use Digital Validation Tools (DVTs) for C&Q by 2024.

Effective containment systems in a pharmaceutical manufacturing facility are essential to protect the health of workers, the environment, and patients receiving the medications. Particles released into the facility can cause adverse side effects to facility employees, and particles released outside the facility can harm the atmosphere and nearby waterways.

Empowerment is providing employees with the autonomy, tools, and trust to make decisions that impact their roles and the organization. It requires a shift from the more traditional directive or micromanagement style to fostering a sense of ownership and accountability.

Cell therapies, especially autologous chimeric antigen receptor T cell (CAR T cell) treatments, are transforming personalized medicine, bringing new hope to patients with conditions once thought untreatable. However, the manufacturing processes for these therapies remain predominantly manual, presenting significant challenges in scalability, consistency, and making these treatments more widely...

Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C&GT) products, frequently require handling steps between quality control release and patient administration. These steps take place directly at the point of care and are especially critical for C&GTs with limited shelf life after preparation.

Advanced therapy medicinal products (ATMPs) have the potential to treat life-threatening, incurable conditions. But access to these therapies remains challenging due to the nature of current ATMP manufacturing models. This article explores solutions, focusing on standardized processing and shared knowledge as gateways to automated, robotic manufacturing and decentralized production.

For patients who depend on personalized medicine, turnaround time matters. However, moving quickly is difficult for cell therapy companies because designing personalized therapies presents unique challenges unknown in traditional biotechnology. In this article, we’ll examine five strategies to help cell therapy companies develop resilience against these challenges, positioning themselves to...

Advanced therapy medicinal products (ATMPs) are transformative therapeutics that are realizing increasing gains in market approvals, yet are expensive products to produce. To enable a broader application of these medicinal products in the marketplace, the cost of goods (COGs) sold should be addressed early in development with a focus on reduction of cost to the patient.

Controlling contamination in environments where biological medicinal products are handled is of paramount importance to ensure the safety of personnel, sterility of drug products, and protection of the surrounding environment. The application of vaporized hydrogen peroxide (vH₂O₂) has emerged as a promising method for postproduction decontamination due to its ability to...

Biopharmaceuticals continue to proliferate in the pharmaceutical industry leading to advancements in advanced therapy medicinal products (ATMPs), cell and gene therapy (C&GT), and other biological products. ISPE supports its membership base of over 22,000 members across more than 120 countries by informing strategies, supporting solutions, and improving processes in this continually...

The 2025 ISPE Biotechnology Conference, scheduled for 2–3 June in Boston, MA, US, and virtually, will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic...

A growing segment of the advanced therapy medicinal product (ATMP) landscape, which includes gene therapies and cell-based treatments, relies heavily on viral vectors for efficient gene delivery. The increasing demand for these therapies requires a robust, scalable, and cost-effective manufacturing solution.

Each year, the ISPE Europe Annual Conference includes a dedicated Women in Pharma^® session, providing an open and collaborative space on professional and personal development. The session fosters meaningful discussions, mentorship, and knowledge-sharing to empower individuals and drive positive change within the industry.

ISPE is an officially recognized stakeholder of the European Medicines Agency (EMA), the agency responsible for the monitoring of medicines in the European Union. One of the ways ISPE helps its members stay at the forefront of industry challenges and changes is by interacting with regulatory authorities in the countries our members represent.

Massimiliano Cesarini, MEng, was named CEO of Biogenera SpA, Bologna, Italy in 2024. He began his career at Duferco Engineering in energy generation, then moved to Comecer Group, holding roles as project and product manager, and global sales manager for the pharma and advanced therapy medicinal product (ATMP) division. He eventually joined Omnia Technologies Group establishing the Omnia Life...

In each issue of Pharmaceutical Engineering^®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Xuandai Hoang, Senior Member Services Coordinator in the Membership Department.

Krisha Patel is Co-Founder of Assurea LLC, a digital compliance consulting firm that provides IT and validation services, software assurance, and custom artificial intelligence solutions for biotech companies. With a degree in bioprocessing science and more than 12 years of experience in computer system validation and quality assurance, Patel has worked with cell and gene therapy companies,...