Progress In Developing Industry Guidelines for Determination of Suitability of Single Use Products f

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Progress In Developing Industry Guidelines for
Determination of Suitability of Single Use
Products for Bioprocess Manufacturing Operations

• Thomas J. Murphy, Ph.D.
• TC Tech Corporation

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Overview

• The Bio-Process Systems Alliance (BPSA)
• BPSA Guidelines and Standards Committee
• Current Progress with Industry Guidelines
• Future Activities

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Bio-Process Systems Alliance (BPSA)

• What is the BPSA?
• Special purpose group of the Society of the
  Plastics Industry, Inc. (SPI)
• Manufacturers of single-use process components
  and systems within the biopharmaceutical industry

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Single-Use System Examples
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BPSA Primary Objectives

• Grow the market nationally and internationally by
  facilitating adoption of single-use components
  and systems
• Establish guidelines and standards for the use
  and disposal of single-use process components and
  systems
• Educate customers, regulatory bodies and
  non-government organizations on the benefits of
  using single-use systems

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BPSA Guidelines and Standards Committee

• Objective
• To provide guidelines/recommendations for how to
  determine the suitability of single-use products
  for bioprocess manufacturing operations

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BPSA Guidelines and Standards Committee

• Current Activity
• Currently developing a matrix to evaluate
  existing standards, guidelines and specifications

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BPSA Guidelines and Standards Committee

• Goal
• Establish a current baseline for documenting the
  suitability of the product as used in
  biomanufacturing

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BPSA Guidelines and Standards Committee

• Subgroups
• Address unique materials of construction and
  field of use for
• Film and containers
• Filters
• Tubing
• Connectors and components

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BPSA Guidelines and Standards Committee

• Standards and Methods in Use Include
• 21 CFR 177 Code of Federal Regulations
• AAMI Association for the Advancement of Medical
  Instrumentation
• ANSI American National Standards Institute
• ASME BPE American Society of Mechanical
  Engineers, Bioprocessing Equipment
• ASTM International
• BP British Pharmacopoeia

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BPSA Guidelines and Standards Committee

• Standards and Methods in Use Include
• EP European Pharmacopoeia
• ISO International Standardization Organization
• ISTA International Safe Transit Association
• FTMS Federal Test Method Standard
• JP Japanese Pharmacopoeia
• NIH National Institutes of Health
• USP United States Pharmacopoeia

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BPSA Guidelines and Standards Committee

• Initial Findings
• Variety of guidelines and standards already in
  use
• Test methods in the physical, chemical/biological
  and functional categories may overlap
• More than one guideline or standard may be
  appropriate for a test method
• Product dependent
• Resin dependent

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BPSA Guidelines and Standards Committee

• Challenges
• Develop appropriate definitions that apply to
  process or product specific tests (e.g.
  sterilization, functionality)
• Define a model system that can be used and
  validated, while taking into account
  process-specific testing
• Address extractables/leachables

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BPSA Guidelines and Standards Committee

• Film Qualification Test Methods Evaluated
  Include

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BPSA Guidelines and Standards Committee

• Filter Qualification Test Methods Evaluated
  Include

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BPSA Guidelines and Standards Committee

• Tubing Qualification Test Methods Evaluated
  Include

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BPSA Guidelines and Standards Committee

• Connector Qualification Test Methods Evaluated
  Include

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BPSA Guidelines and Standards Committee

• Leachables/Extractables
• Proposed Definitions for BPSA Guidelines
• Extractables
• Substances that can be extracted from a
  bioprocess container using solvents and/or
  conditions that are expected to be more
  aggressive than the conditions of contact between
  the container system and a relevant
  pharmaceutical solution
• Leachables
• Substances that are present in the finished
  drug product because of the interaction with a
  bioprocess container system

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BPSA Guidelines and Standards Committee

• Leachables/Extractables
• Proposed Roles and Responsibilities of Vendors
  and Suppliers
• Suppliers of bioprocess container systems
  provide vendors of finished drug products a full
  and complete extractables assessment of their
  system
• Vendors of the drug product supply regulators
  with a full and complete leachables assessment
  for their finished drug product
• Vendor and suppliers attempt to correlate the
  extractables and leachables information

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BPSA Guidelines and Standards Committee

• Leachables/Extractables
• Proposed Characteristics of a Full and Complete
  Extractables Assessment
• Extraction of the system with a minimum of three
  chemically diverse extraction solvents.
• Multiple extraction conditions (duration,
  temperature material weight to extraction
  solution volume) determined to be more aggressive
  than the typical conditions of use of the system
• Analysis of extracts
• Detection of the extracted substances
• Identification of the extracted substances
• Quantification of the extracted substances

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BPSA Guidelines and Standards Committee

• Leachables/Extractables
• Proposed Characteristics of a Full and Complete
  Extractables Assessment
• Supplier will document the identity and
  concentration of extracted substances detected in
  the extracts
• Supplier may perform and report such studies as
  may be appropriate or necessary to establish the
  source of extracted substances
• Drug vendor would directly use such information
  to establish the safety, efficacy, and/or
  compliance of its finished product through an
  appropriate safety assessment based upon the
  actual leachables profile

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BPSA Guidelines and Standards Committee

• Future Activity
• Continue identification of commonalities,
  differences in guidelines, standards
• Each test type
• Each of the four component categories
• Include definitions
• Review differences
• Can single guideline or standard be used?
• Do different conditions necessitate options?
• Define model system that can be used, validated

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BPSA Guidelines and Standards Committee

• We want to hear from you!
• Talk with BPSA members here at the conference
• Provide us with your input on guidelines and
  standards for single-use components and systems
• Contact Donna Dempsey, Executive Director, BPSA
  for more information
• Visit the BSPA Web site at www.bpsalliance.org

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For more information, contact

• Donna S. Dempsey
• Executive Director, Bio-Process Systems Alliance
  (BPSA)
• The Society of the Plastics Industry, Inc.
• Washington, DC
• [phone]
• ddempsey_at_socplas.org
• www.bpsalliance.org