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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.

This is achieved by collaborating with each other, supplier partners and health agencies to define manufacturer requirements and best practices which are then used to implement modern biopharmaceutical supply chains.

Benefits include:

  • 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
  • Implementing a harmonized risk-based approach to single-use change notifications, thus lowering risk to licence by defining appropriate notification periods with the supply base
  • Delivering industry alignment on internal release testing requirements for single use system (SUS) materials

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