LONG READHarmonizing the industry and improving confidence through risk-based microbial testingThe integrity of...
Drug Substance (DS) aims to accelerate the way our operations deliver near- term results.
The program is informed increasingly by the Technology Roadmap as well as members’ immediate needs to improve manufacturers’ licenses to operate. Teams here have led the drive to make single-use technologies as easy to specify and implement as stainless steel, and continue to help members to realize step changes in microbial control, quality management systems, and the use of closed systems; as well as pushing back the barriers on post-approvals submissions with a growing number of authorities.
The DS Phorum enables biomanufacturers to collaborate on their most challenging operational strategies.
DS addresses strategies that cannot be achieved in isolation, but require a critical mass of users to define common requirements for suppliers or to align on interpretations of regulatory requirements.
external publications and presentations
- implementing a risk-based Deviation Management System, releasing up to 12,000 hours per annum for a typical site and so enabling improved investigation and CAPA effectiveness
- reduced risk to license to operate by addressing subjects of microbial control concern to regulators in the form of best practice protocols
- introducing type tested valve diaphragms which reduce changeout frequency from 6 to 24 months, delivering 30% increase in asset utilization, saving ~ 40% engineering labor and use of ~ 50% fewer seals
- drawing upon standard supplier extractables data defined by the BioPhorum protocol and instituting a risk-based approach to leachables testing, thus reducing significant effort and lead time
- introducing a standard and optimized shipping validation best practice process and so securing $500,000-$1.0 million annual savings and reducing validation timelines by 6-12 months
- Technology Roadmap Adoption – In Line Monitoring/Real Time Release
- Making and Moving Cell Banks
- Microbial Control
- Closed Systems
- Storage and Transport
- Post Approval Strategies
- Simplify QMS – Change Control
- CPV & APR Integration
DS members are joined by members of the Supply Partner (SPP) Phorum in relevant workstreams:
Single-Use Joint Leadership Team
- Disposables – Supplier Reliability
- Disposables – Design Harmonization
Raw Material Joint Leadership Team
- Raw Material – Media and Analytics
- Raw Material – Standards and Procedures