Managing a Tech Transfer Redesign Post-Acquisition

Managing a Technology Transfer (TT) is often complex, and redesigning an existing TT process even more so. Companies will generally redesign their TT processes to accommodate changes in technology, regulatory requirements, clinical strategies, or other similar reasons. However, even repurposing a manufacturing facility can drive a TT redesign. We recently supported such a redesign when a CMO client acquired a previously internal manufacturing site.

Tech transfer redesign management can be complex.

Not surprisingly, differences in TT approaches became evident early on. Internal manufacturing sites often seek to optimize the production of internal products and platforms, and then serve as a TT “sending unit” for higher volumes. A CMO operates differently, however, manufacturing products for different clients with a variety of platforms and needs. They typically act as a “receiving unit” of TT.

Ashutosh Pandit is trained in finance and strategic advisory services with experience in financial modeling, research, consulting, and data analytics. He provides project management and FP&A support for major CMC, Quality, and Supply Chain initiatives such as Tech Transfer projects, CMC dose delivery programs, PAI Readiness initiatives, QA investigations and Quality Systems assessments.
Ulpiano Flores is a consultant with a chemical engineering background. He supports CMC, Quality, and Supply Chain initiatives such as FMEA risk assessments, Clinical Supply Chain systems, Quality documentation and vendor management, Tech Transfer projects, and Serialization.

For our client, this meant a complete change in the acquired site’s operating model and warranted consideration of unique factors, such as:

  • Establishing a customer-centric focus to the redesign while developing new processes
  • Aligning best practices between the site and the global organization
  • Avoiding duplication and enabling efficiency while revising documents and generating new ones
  • Creating a more detailed equipment and infrastructure evaluation process

Critical Tech Transfer Redesign Considerations for an Acquiring CMO

Establishing a Customer-Centric Approach

The TT process for a CMO has more customer touch points to ensure it meets requirements (e.g., approving the process description, providing a manufacturing go/no-go). Given that the acquired facility was now part of the CMO, special effort was undertaken to instill a customer-centric approach while developing the TT tools.

Aligning Best Practices

Developing strategies for aligning and blending the acquiring company’s practices and standards with best practices from the acquired facility is key for a CMO undertaking a TT redesign post-acquisition. In the example above, the manufacturing facility had developed its own best practices as a captive internal site, and the team felt those practices were working well. As a result, our redesign process began with a comprehensive assessment of their existing processes and pain points. This involved not just analyzing manufacturing protocols, equipment, and documentation, but also speaking with key personnel to identify gaps or inefficiencies. Deciding which methods should stay, which ones should change to adopt global best practices, and which situations may require new processes, is even more important in a situation like this (versus a regular TT redesign).

Additionally, to ensure cross-functional and global alignment, we conducted a two-day whiteboarding session with stakeholders to jointly map the TT process across key functions of the organization. This resolved differences in understanding of the process, as well as functional roles and responsibilities. The approach also builds alignment on common assumptions, and can prevent higher costs, unforeseen execution delays, and loss of credibility with customers.

Thoughtful Recrafting of Documentation

Revising long, confusing, and outdated documentation is one of the most common pain points facing our clients. It can be an even bigger issue for a CMO acquiring an internal manufacturing site. This is primarily due to variations of similar documents at both the acquiring CMO and the acquired site. Thus, our team started with the acquired facility’s documentation, recrafting it to be clear, concise, compliant, and aligned with the CMO’s global organization. Besides integrating industry best practices, this approach captured the expertise and tacit knowledge of the existing facility’s personnel through their SOPs, TT plans, checklists, and project plans.

Evaluating Equipment & Infrastructure with the Possibility of Changeovers

Redesigning the TT process for an acquired site also requires a thorough evaluation of the existing equipment and infrastructure. With multiple customers potentially utilizing the same space and equipment, CMOs need to account for changeovers. This includes feasibility assessments to ensure there is enough infrastructure and capacity available to facilitate manufacturing. Thus, we assessed the compatibility of the acquired facility’s equipment with its own manufacturing processes and standards. Any necessary upgrades, replacements, or modifications were identified and addressed. Calibration and validation procedures were reviewed based on whether they met regulatory requirements and maintained consistent product quality. Only then could appropriate feasibility assessment tools be developed effectively.

Key Takeaways

With continued industry consolidation and growing reliance on CMOs, we expect to see more strategic acquisitions.  While redesigning a TT process is always complex, understanding the unique TT considerations and requirements when repurposing an internal manufacturing facility is more important than ever.

  • CMOs must ensure organizational alignment, but are best served when also allowing for adoption of current site best practices.
  • It is crucial to establish a customer-centric focus while developing tools for the site’s new TT process.
  • Working from the site’s existing documentation helps new documentation to be clear, concise, compliant, and aligned.
  • CMOs should undertake a detailed evaluation of the acquired site’s equipment and infrastructure, then use the results to develop suitable feasibility assessment tools.