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.
- Lean Qualification and validation
- Disposables – Testing, Validation and
Quality Release Standards
- Disposables – Supplier Reliability
- Disposables – Change Notification
- Disposables – Design harmonization
- Disposables – Single-Use User Requirements
- Disposables – Extractables and Leachables
- Microbial Control
- Human Performance
- Raw Material Variation
- Closed Systems
- Deviation Management Systems
- Simplify Quality Management Systems – Change Control
- Post Approval Strategies
- Storage and Transport Extractables Continued Process Verification
- 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