Technology Transfer Support

With decades of collective expertise in transferring processes for product development companies worldwide, we ensure successful transfer of technology and processes for scale up as well as to multiple sites.

We do this through our “Right at First” approach that mitigates a push back by time which can erode the bottom line of your company. We bring in expertise in strategizing knowledge transfer as per your need and regulatory expectations. We provide:

  • Customized framework developed from ready to use frameworks (compliant to ICH Q10 and WHO guidelines)
  • Program and Project Management support and encourage Active Senior Leadership involvement
  • Gap assessment support both at high level and at product level with documentation

5 step Technology transfer support process

SUCCESSFUL PROCESS OPTIMIZATION AND SCALE UP FOR A BIOSIMILAR

Small scale process at 10L scale, optimized with IBPS’s subject matter expertise in Bioprocess Development ultimately led to a process that was superior to the first generation process in terms of better process control, good consistency, and significantly improved yield which was successfully scaled up to 12000L scale and transferred to Manufacturing for clinical trial material generation. This successful scale-up enabled the Client to file timely for its biosimilar product in regulated markets.