Drug Substance

Overview

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.

Workstreams

  • 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
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Priority publications for BioPhorum Drug Substance

Benefits

  • 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
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workstreams

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face-to-face meetings

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active participants

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member companies

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external publications and presentations

Drug Substance case study

Biogen SwissMedic Regulatory Challenge – $25M and 12-month project delay saved

CIn 2013, Biogen began construction of a new facility in Luterbach, near Solothurn, Switzerland, expected to launch 2019…

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