Tech transfer in oral solid dose (OSD) manufacturing is one of the most critical, and often underestimated, phases in the drug development lifecycle. For CDMOs, it’s a moment where scientific precision meets operational discipline. For late stage biotech companies approaching their first commercial launch, it can be a steep learning curve. With an experienced tech transfer team operating at Upperton, we’ve seen firsthand what works, what doesn’t, and what biotechs can do to set themselves up for success.
Late-stage tech transfer typically occurs after Phase III trials, when the formulation is locked, regulatory filings are underway, and the product is on the cusp of commercialisation. At this point, the process must be replicated exactly, scaled appropriately, and validated under GMP conditions. Unlike early-stage transfers, where flexibility and iteration are expected, late-stage transfers demand consistency, documentation, and alignment across multiple functions. At this stage, risk is also increased, therefore leading to the importance of the CDMO risk assessing the entire process from both the biotech and the CDMO standpoint.
One of the most common challenges biotechs encounter is documentation quality. Often, the development work has been conducted across multiple sites or partners, and the resulting documentation can be fragmented or inconsistent. For biotechs, this is especially common. Many operate with lean teams and rely on external partners for formulation and clinical manufacturing. When it comes time to transfer the process to a commercial CDMO, gaps in documentation can slow progress and introduce risk.
Our advice: start early.
Conduct a documentation audit before initiating the transfer. Ensure that raw material grades, equipment lists, analytical methods, development reports, batch records and stability data are available, complete, standardised, and ready for scrutiny.
Another frequent issue is equipment mismatch. Even when the process is well understood, differences in equipment between the development site and the commercial facility can impact product performance. For example, changes in blender geometry, compression tooling, or drying parameters can affect critical quality attributes like content uniformity or dissolution. Biotechs may not always have the in-house expertise to assess these differences, which is where a CDMO’s experience becomes invaluable. In particular, CDMOs like Upperton that operate on one site, and are experienced with transferring projects from R&D through to commercial facilities are more likely to understand potential pitfalls, and to take the steps to avoid them.
The pressure to meet urgent medical needs and accelerate patient access often leads to condensed timelines in late-stage projects. Sponsors are eager to meet regulatory milestones and prepare for launch, and tech transfer becomes one of many parallel activities. This creates pressure on both sides to execute flawlessly. In our experience, the key to managing this is clear communication. Establish a single point of contact, agree on timelines and deliverables, and hold regular project meetings.
One of the most overlooked aspects of tech transfer is the transfer of tacit knowledge. Documents can only tell part of the story. The real insights, such as why certain parameters were chosen, how deviations were handled and what lessons were learned during development often reside with individuals. For biotechs, this knowledge may be held solely by a small number of scientists or consultants. We encourage joint technical workshops, site visits, and informal Q&A sessions to ensure that this knowledge is captured and shared. This way, tech transfer extends beyond transferring process, and instead transfers understanding.
Risk management is another cornerstone of successful tech transfer. Late-stage projects leave little room for error, and any deviation can have regulatory implications. We use structured tools to identify potential risks and develop mitigation strategies and build quality into the entire process. For biotechs, this can be particularly helpful in navigating unfamiliar territory. It provides a framework for decision-making and ensures that risks are addressed proactively rather than reactively.
Validation is often closely tied to tech transfer. The transferred process must be robust, reproducible, and compliant with GMP standards. Planning for this early by identifying suitable batches for validation, aligning protocols with regulatory requirements, and ensuring readiness across quality systems helps avoid last-minute surprises which could lead to delays in product commercialisation. Biotechs should also be aware that any changes made during transfer must be justified and documented. Regulatory agencies expect a clear rationale supported by data, and a CDMO can help prepare the necessary documentation packages and responses.
For biotech companies, late-stage tech transfer is often their first experience with large-scale manufacturing. The transition from clinical development to commercial-scale manufacturing involves a complex interplay of regulatory compliance, process optimisation, technology transfer, and supply chain coordination which makes it a substantial and often daunting phase for emerging biotech companies. That’s why choosing the right CDMO partner is so important. Beyond technical capabilities, look for a partner who understands the pressures of a first launch, who can offer regulatory guidance, and who is committed to collaboration.
At Upperton, we’ve built our tech transfer team to manage these transitions. Their role is to coordinate across departments, anticipate challenges, and ensure that nothing gets lost in translation. They also serve as a central point of contact for the sponsor, streamlining communication and decision-making. For biotechs, this structure provides reassurance and clarity, two things that are invaluable during a complex transfer.
Digital tools have also transformed how we manage tech transfers. Platforms for document sharing, data analysis, and project tracking have streamlined collaboration and reduced administrative burden. They allow for real-time visibility, faster decision-making, and better alignment across geographically dispersed teams. For biotechs working with global partners, these tools can be a game-changer.
Late-stage tech transfer in OSD Manufacturing is a complex, high-stakes process. For biotechs, it’s a huge moment that has often been years in the making. By applying lessons learned and embracing best practices, we help sponsors move confidently toward commercialisation, ensuring that their products reach patients safely, efficiently, and compliantly.