Welds used in biopharmaceutical manufacturing must meet critical criteria to maintain a defined level of purity and bioburden control. One highly debated area of concern is the level of discoloration allowable on the product contact surfaces in the welded condition and secondary finishing methods. This article addresses the studies commissioned by the American Society for Mechanical Engineers...
Each year, ISPE recognizes innovation in pharmaceutical facilities with the Facility of the Year Awards (FOYA). The 2024 FOYA submission finalists were announced at the 2024 ISPE Aseptic Conference in Vienna, Austria. Finalists for the 2024 awards highlight the continued progress and innovation at play in pharmaceutical manufacturing worldwide and across modalities. From projects tailored to...
The ISPE International Company of the Year award recognizes outstanding leadership and support provided by a company, as reflected by significant active participation in the Society’s committees, Communities of Practice (CoPs), programs, and activities, as well as its support of employee participation in ISPE. The winner for 2023, Roche, was announced at the 2023 ISPE Annual Meeting & Expo...
The 2024 ISPE Annual Meeting & Expo will be held 13–16 October in Orlando, Florida, and virtually. David Churchward is the conference’s Executive Chair. He offers advice and shares what attendees can expect at the upcoming conference.
Implementing advanced automation technologies is a strategic move that can amplify the positive outcomes of environmental, social, and governance (ESG) initiatives. By leveraging ESG initiatives, pharmaceutical companies can enhance their competitive edge and contribute positively to global sustainability efforts.
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies is accelerating, introducing tough decisions for manufacturing development. Gene editing therapy production is complex, often involving multi-modality manufacturing operations in one facility to produce a single therapeutic. This article considers whether retrofitting an aging monoclonal...
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular therapeutics, has driven steady investment in facilities capable of manufacturing these therapeutics at scale . Meanwhile, the industry is collectively moving to adapt to European Union Annex 1 standards, which places a more stringent emphasis on contamination control.
The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies provide new opportunities to boost productivity through continuous process improvements. The Pharma 4.0™ framework, an adaptation of the broader Industry 4.0 movement, aims to transform how drugs are produced and delivered.
As we get into the peak of the summer months and everyone is preparing for a well-deserved vacation, ISPE is in full swing. We just had a great Biotechnology Conference in Boston. Attendees heard about topics ranging from the use of digitization and artificial intelligence in manufacturing to quality systems maturity and the quality culture required to manufacture safe and efficacious...
Every year we celebrate the achievements of state-of-the-art pharmaceutical facility projects through the Facility of the Year Awards (FOYA). The buildings are beautiful, energy efficient, and sustainable; the...
