The approved variation enables Upperton to commence GMP manufacture of sterile investigational medicinal products from its purpose-built facility, expanding integrated development and manufacturing services to include sterile clinical supply.
Key Capabilities
The new sterile manufacturing suite supports lyophilised vials, liquid-filled vials and pre-filled syringes. Isolator technology provides the highest level of environmental protection for aseptic processing of clinical supplies.
Annex 1 Alignment
The revised EU GMP Annex 1 introduced stricter expectations for sterile medicinal product manufacture, with a strong emphasis on contamination control. The 7,000 sq. ft facility was designed and commissioned in line with these requirements, with a comprehensive Contamination Control Strategy embedded from concept through qualification and routine operation.
Integrated Development and Manufacturing
By co-locating sterile manufacturing with existing pharmaceutical development services, sponsors gain a seamless route from formulation development to clinical supply. This integrated model reduces technology transfer risk, improves communication and accelerates sterile drug product programs.
About This White Paper
This white paper is published by Upperton and curated by Biotechnology Media Insights, a trusted source for pharmaceutical and biotechnology research, technical guides and industry analysis.