SAFC Converts Facility to Animal Component Free Status
SAFC Biosciences (Lenexa, KS) has completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, KS to animal component free (ACF) status. This is the first of several similar conversions planned by SAFC Biosciences to support growing customer requirements for ACF manufacturing.
SAFC Biosciences (Lenexa, KS) has completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, KS to animal component free (ACF) status. This is the first of several similar conversions planned by SAFC Biosciences to support growing customer requirements for ACF manufacturing.
During this facility’s ACF conversion, an extensive cleaning conversion protocol was completed and systems and procedures were reviewed and modified. This process addressed several comprehensive factors, including:
• Cleaning protocol and documentation
• facility analysis of air, personnel, equipment, and process flows
• raw material procedures—from receipt, inspection, sampling, quarantine, and storage to release
• standard operating procedures review against ACF requirements, with changes implemented to cover product sampling, personnel and product flows, and cleaning
• personnel training records review and pertinent training updates before ACF conversion
• risk analysis performed on all equipment and components used in ACF areas
• ACF status and manufacturing information collected on all raw materials
• contamination remediation plan instituted for any system breech, including provisions for equipment decontamination, cleaning procedures, personnel and process flows, timelines and business continuity planning.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
