Drug Substance

Our aim is to enable bio-manufacturers to collaborate on their most challenging operational strategies; those that can’t 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.

 

Biopharma manufacturers achieve their goals by collaborating with each other, their supplier partners and health agencies to define manufacturer requirements and best practices which are then used to implement modern biopharma supply chains.

The program is developed and owned by the governing body of biopharma manufacturers. This ensures that the topics worked on are of the highest importance to operational leaders and aligned to their own corporate goals.

 

BENEFITS:

Drug Substance Members’ benefits include:

  • Releasing up to 12,000 hours per annum for a typical site by implementing a risk-based Deviation Management System and so enabling improved investigation and CAPA effectiveness.
  • Delivering 30% increase in asset utilization by introducing type tested valve diaphragms which reduce changeout frequency from 6 to 24 months; also saving ~ 40% engineering labor and use of ~ 50% fewer seals.
  • Reducing significant effort and lead time by drawing upon standard supplier Extractables data defined by the BPOG protocol and instituting a risk-based approach to Leachables testing.
  • Securing $0.5-1.0m annual savings and reducing validation timelines by 6-12 months by introducing a standard and optimized shipping validation best practice process.
  • Reduced risk to License to Operate by addressing subjects of microbial control concern to regulators in the form of best practice protocols for Low Endotoxin Recovery, Mold Control, Anaerobic Bioburden detection and Affinity Capture Chromatography Processing.
  • Improving decision-making regarding company and industry raw material priorities by establishing common processes and database for evaluating, sharing and communicating industry-level risks associated with raw material supply.
  • Lowering risk to licence by defining appropriate notification periods with the supply base by implementing a harmonized risk-based approach to Single Use Change Notifications.
  • Reduced risk of regulatory scrutiny by having industry alignment on internal release testing requirements for SUS materials.
  • Improving quality and robustness of SUS materials by ensuring SUS vendor audits are value added by focusing on key requirements of Quality Systems specific to SUS.

 

MEMBERS INCLUDE:

BioPharma manufacturers and CMOs.

Suppliers invited as guests to address commodity-related problems

 

PHORUM INFLUENCE (PI):

 

 

 

 

FREE RESOURCES:

Packs of guidance and tools for implementation

Extractables and Leachables

Change Notification

PUBLICATIONS:

 

Training for Biotech Manufacturing Operator Competence White Paper

Patient-centric requirements for the supply of raw materials into biopharmaceutical manufacturing White Paper

Maintenance Frequency Optimization Tools And Processes White Paper

Human Performance – PDA Journal

Continued Process Verification Case Study White Paper

BPOG response to Annex 2

A roadmap for the implementation of Continued Process Verification

Study shows new cleaning methods obtain functional closure in CNC areas

Human Performance case study

Microbial Monitoring for Drug Substance Manufacturing: An Industry Perspective

Misconceptions of Maintenance and Reliability

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