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PQRI Work Project Concept. Fundamental Understanding of Sulfonate Ester-Forming Reactions April 2006. Objective of Work Project. Description of overall objective of work project What are the challenges (issues with product quality) the project (deliverable) is intended to address?

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pqri work project concept

PQRI Work Project Concept

Fundamental Understanding of Sulfonate Ester-Forming Reactions

April 2006

objective of work project
Objective of Work Project
  • Description of overall objective of work project
  • What are the challenges (issues with product quality) the project (deliverable) is intended to address?
  • Is this problem worth solving and if so, Why?
  • Definition of key stakeholders (i.e., what is the target audience; who will be interested in the results?)
background of work project
Background of Work Project
  • Concern exists that sulfonate esters may be genotoxic impurities and are potentially formed during drug substance manufacturing when sulfonic acids are used in the presence alcoholic solvents
  • The elimination of sulfonic acids from drug substance manufacturing would be highly undesirable due to its useful synthetic properties
    • This is a potential regulatory outcome if the issue is not addressed
  • The amount of sulfonate esters formed under synthetically relevant conditions is currently unclear
objective of work project4
Objective of Work Project
  • To scientifically demonstrate that sulfonic acids can safely be used in drug substance manufacturing by
    • Understanding the kinetics of formation and decomposition of sulfonate esters during drug substance manufacture under synthetically relevant conditions
    • Demonstrating that conditions can be manipulated to control the levels of sulfonate esters formed
key stakeholders
Key Stakeholders
  • Global regulatory agencies
    • The question of potentially genotoxic impurities is of significant concern to them, this adds to the body of available knowledge and allows them to use science to make better decisions
  • Pharmaceutical manufacturers
    • Data on impurity formation would allow the possibility of a scientific discussion with regulators on required controls and support continued use of sulfonic acids
    • Would also provide useful synthetic knowledge to allow minimization of the formation of sulfonate esters
key deliverables and outcomes
Key Deliverables and Outcomes
  • Definition of key deliverables and approximate timeline required to achieve each deliverable
    • Method development (timing depends on difficulties encountered)
    • Experimental protocol design
    • Execution of experiments to demonstrate impact of synthetic parameters on formation of sulfonate esters
    • Final output available in March of 2009
  • What are the potential risks involved with the project?
    • Data collected is not valuable in answering the question
    • Considered to be highly unlikely, i.e. project should have a meaningful outcome
impact of work project
Impact of Work Project
  • If this project is successful, what would be the impact on product quality?
    • Data would be available that would demonstrate how the formation of sulfonate esters can be controlled and thus allow the continued use of sulfonic acids in synthesis
    • Discussion with regulators on controls necessary to mitigate the risk of sulfonate esters, including specifications, can be based on science
communication of work project
Communication of Work Project
  • Description of intent of external communication (e.g., to provide best practice, to influence regulatory policy, etc.)
    • To influence regulatory expectations, as described earlier
  • Description of internal and external communication plan (e.g., white paper, published article, workshop, etc.)
    • It is expected that several technical papers in peer-reviewed journals will be published
funding requirements
Funding Requirements
  • It is estimated that somewhere between 100K and 300K will be required to fund this project through to completion (spread over about 2 years)
    • It is anticipated that a contract lab will be hired to perform the method development and subsequent experiments
    • It may be necessary to hire a project manager
    • Funds will be needed from PQRI but there is a possibility that member organizations will partially fund due to high interest level
skill knowledge set
Skill/Knowledge Set
  • Define the skills/knowledge sets necessary to complete the work project
    • Synthetic and analytical chemists
  • Outline the plan for obtaining necessary skills (e.g., contract with external expert, utilize member organization expertise, etc.)
    • May be a combination of internal and external expertise; plan to investigate possibility of contract lab and project manager