By J.D. Mowery, President, Bora CDMO Business
Technology transfer is often described as a “handoff,” but it is a far more dynamic and interdependent process than that simplified view suggests. In reality, commercial technology transfer is a high-stakes collaboration that requires deep technical and regulatory knowledge, proactive planning, and operational alignment long before a product is ready to reach the market.
As products move from late-stage development to commercial scale, the pressure intensifies. With timelines narrowing and investors closely watching, even small gaps in process understanding, supply readiness, or partnership alignment can create serious delays.
How can sponsors move beyond simply avoiding delays and instead build a tech transfer strategy designed for commercial success from day one?
Designing Processes for Commercial Readiness
Quality by Design (QbD) has reshaped how our industry thinks about process development. By defining critical process parameters (CPPs) and critical quality attributes (CQAs), teams can build quality into the process from the start rather than try to work it in at the end. This shared framework also creates a common technical language between development and manufacturing teams, which is invaluable during scale-up.
But scaling to commercial manufacturing introduces challenges that aren’t always fully anticipated during development. Even within the same organization, differences in equipment trains between sites can introduce unexpected complexities. As batch sizes increase dramatically throughout scale-up, efficiency and flexibility matter just as much as robustness. Additionally, when development programs over-register or over-specify parameters too early, they can inadvertently constrain commercial operations down the road. For example, it has become increasingly common to register bulk hold times early on, going above and beyond what is required at that phase. While often done in the spirit of risk mitigation, this rigidity can limit a manufacturing team’s ability to optimize line utilization, respond to demand variability, or manage production scheduling.
A commercially minded tech transfer strategy starts with asking:
- Which parameters are truly critical to product quality?
- Where does regulatory flexibility exist?
- What future improvements might we reasonably anticipate post-approval?
Bora’s scale-up and commercial teams work with sponsors to review what has been registered, identify areas of operational constraint, and define a roadmap for post-approval management. This ensures the process is not only compliant on day one, but adaptable for success in the years ahead.
Scale-Up Is a Supply Chain Exercise
Process readiness without material readiness is a recipe for disaster. Supply chains have evolved significantly over the last five years, with lead times doubling, vendors operating leaner, and communication becoming more fragmented. In this environment, assuming raw materials will be available when we need them is one of the most common and costly misconceptions.
For commercial transfer, supply chain planning must begin in parallel with tech transfer activities, not after them. That means:
- Aligning early on preferred suppliers for onboarding and validation
- Forecasting long-lead materials at least six months in advance
- Considering strategic stockpiling of critical raw materials during transition periods
At Bora, we emphasize early integration between our technical operations and procurement teams. When a six-month excipient delay can derail an otherwise flawless transfer, engaging early allows us to build supply continuity plans that protect launch timelines.
Lock In a Partnership Before Pressure Begins
One of the most overlooked drivers of delay is timing, specifically when the CDMO relationship begins. Sponsors often wait for a definitive Phase III outcome or financing event before initiating serious CDMO engagement. While understandable, this compressed timeline forces critical activities such as RFP processes, documentation alignment, equipment fit assessments, and supply chain onboarding into an already crowded window.
The most successful commercial transfers we see are when the relationship was established early. By the time a critical milestone hits, both teams should already be aligned on:
- Communication cadence
- Key team structure
- Decision-making processes
- Risk tolerance
- Timeline expectations
When technical questions arise as they inevitably do during scale-up, teams that already understand each other’s systems and working styles resolve them faster. This is especially critical in today’s environment of accelerated approvals and competitive therapeutic categories where there is little room for onboarding delays. Fostering partnership early on creates the operational bandwidth needed to execute confidently under pressure.
Collaboration is the Key to Commercial Success
Ultimately, commercial technology transfer is not about eliminating every challenge; it’s about anticipating them. Sponsors who succeed approach tech transfer as a strategic collaboration grounded in three pillars:
- Flexible processes designed for commercial readiness
- Proactive and realistic supply chain planning
- Early, trust-based CDMO partnerships
When these elements are aligned, transfer becomes less reactive and more deliberate. Timelines become more achievable and teams can shift their energy from troubleshooting preventable delays to optimizing performance and preparing for future growth.
In a competitive and rapidly evolving pharmaceutical landscape, the difference between delay and launch often comes down to preparation and partnership. By designing for commercial reality and not just regulatory approval, sponsors can treat technology transfer as an opportunity for competitive advantage rather than a checkpoint.