In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Matt Lehmann, Custom Training Manager, Professional Development.
The 2024 ISPE Facilities of the Future Conference opened on 29 January in San Francisco, California, with a series of six keynote presentations on innovations that are leading to advanced...
The 2024 ISPE Biotechnology Conference will be held 17–18 June in Boston, Massachusetts, and virtually. Phillip R. Smith is the conference’s Planning Chair. He shares what attendees can expect at the upcoming...
One of the primary technical objectives of the ISPE Pharma 4.0™ Plug and Produce Working Group is to assist the Pharma 4.0™ digital transformation by enabling seamless integration and interoperability between all systems components and operational technology to advance the overall digital maturity toward predictive and adaptable operations.
The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide: Advanced Therapy Medicinal Products – Recombinant AAV Comparability and Lifecyle Management were published earlier this year. These guides add to ISPE’s library of knowledge in the growing and ever-evolving advanced therapy medicinal products (ATMPs) field.
The ISPE Baseline® Guide Volume 5: Commissioning and Qualification (Second Edition) framework has gained significant attention, use, and adoption since the...
Glenn Lawrence’s first position at Merck & Co. was as a shift engineer for a large factory in Rahway, New Jersey. It was a great learning ground for chemical processing and automation. Glenn was in operations when he was asked to join the engineering department, where he did plant design for active pharmaceutical ingredients and vaccines. He was then asked to take over the engineering...
Laura-Ann Chin has more than 12 years of international and domestic contract and hands-on process engineering experience in the design and construction of current GMP facilities in the US, Europe, and Asia. She specializes in single-use solutions and modular technologies for scale-up, scale-out, and technology transfer in maximizing the performance of advanced therapy medicinal products,...
Frances (Fran) M. Zipp was awarded the ISPE Joseph X. Phillips Professional Achievement Award at the 2023 ISPE Annual Meeting and Expo. The award is named in honor of Joe Phillips, longtime supporter of ISPE and a leader in establishing the Society as an “integrator” of industry and regulators, both during his years of service with the FDA and later when he became International Regulatory...
In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and ensuring quality is a critical success factor. An effective quality risk management (QRM) system is a key component in the overall quality management infrastructure of biopharmaceutical organizations. It offers a structured, scientific, and risk-based approach to decision-making, addressing potential...
