Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory



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Doctors and Scientists

Case Study Technical Transfer of Manufacturing Methods and Processes

Benefits of Case:

  • Access to manufacturing capacity at qualified vendors
  • On schedule program despite unusual ex-U.S. challenges
  • Flexibility in dose alterations during program execution

Background and Challenge:

The Client obtained rights to develop an investigational drug for a series of new indications. The Client required rapid turnaround on transfer of manufacturing and analytical methods, along with exploratory formulation research on different excipients and dose strengths. The Client had no ability to transfer or store their GMP API from Japan (which had challenging storage requirements). Additionally, GMP API was immediately needed for manufacturing Phase 1 & 2 clinical trial material.

PharmaDirections Strategy:

  • PharmaDirections utilized its integrated network of drug development laboratories and formulation development experts to provide the Sponsor with a turnkey solution for the receipt and storage of API, manufacture and reformulation as well as packaging and release of clinical trial materials
  • Rapidly responded to the Sponsor’s request within original aggressive timeframe by avoiding typical lag times due to vendor set-up arrangements, quotes and agreements

The Objectives:

  • Accelerated receipt of ex-U.S. GMP material
  • Accelerated transfer of manufacturing processes for Phase 1 & 2 clinical trial materials
  • Accelerated development of higher dose tablet prototypes

Value for the client:

  • Single contract for client with PharmaDirections open network of service providers with pre-established contracts in place
  • Team of experts on call to quickly provide guidance for Sponsor’s program
  • Clinical study was performed on schedule under challenging conditions where dose was not well-understood and required changes throughout the CTM program

Results from PharmaDirections Combined Experience and Expertise:

By using transferred methods concurrently with the development of new dose strength prototypes, the Client was able to receive the GMP materials it required ahead of schedule.