Most pharmaceutical companies treat technology transfer as a documentation exercise. Transfer the batch records, ship some reference standards, schedule a few calls with the receiving site. The reality is that success requires transferring not just the paperwork but the knowledge that makes the process work.
Trade policy discussions for 2026 are creating uncertainty around manufacturing locations. Potential tariff changes, domestic content requirements, and supply chain mandates could force pharmaceutical companies to relocate production with limited notice.
Pharma companies that are building transfer capabilities can respond efficiently when these changes hit. Companies that wait will spend years troubleshooting failures that could have been prevented with preparation.
The Knowledge Gap Problem
What Documentation Misses
Batch records tell companies what happens during manufacturing. They don’t explain why certain process parameters matter, how operators will know when things are running correctly, or which variables affect product quality that can be determined only during stability testing.
This information is held by development scientists and experienced operators who recognize which machine adjustments matter during scale-up, which visual cues indicate proper blending, and which equipment quirks affect product performance. Standard batch documentation wasn’t designed to capture this, so most technology transfers start off insufficiently.
The receiving site follows the documentation exactly, but gets different results. Teams spend weeks troubleshooting which undocumented variables cause the difference.
Companies with experience in drug delivery development know that a successful transfer needs more than documents. It needs direct exchange between technical teams who can explain not just procedures, but the reasoning behind them.
Equipment Differences Create Problems
Equipment differences compound this gap. Even equivalent equipment behaves differently based on manufacturer, model, or configuration. Coating equipment that appears identical may produce different film thicknesses due to differences in pump design. Mixing vessels of the same capacity produce different shear patterns depending on impeller geometry or vessel dimensions.
These differences matter most for complex drug delivery systems, such as transdermal patches and oral thin films, where product performance depends on controlling multiple interacting variables. Coating thickness that was consistent on one line varies on another. Drying parameters that worked at the original site produce different results at the new equipment site.
Without capturing which process fundamentals must remain fixed and which can flex, these equipment differences can lead to months of expensive troubleshooting.
What the FDA Requires
Demonstrating Process Equivalence
The FDA’s technology transfer guidelines require receiving sites to demonstrate they can manufacture products that meet all quality attributes established during development. A few validation batches that pass specifications aren’t enough.
Regulatory submission requires proof that the transferred process produces equivalent results across the normal range of manufacturing variation. That means comprehensive characterization of critical quality attributes, validated analytical methods at the receiving site, and process controls that maintain consistent quality through the product’s expiration date.
Managing Regulatory Changes
For established products, any changes during transfer trigger regulatory assessment. Even minor modifications to equipment, materials, or process parameters may require stability studies or comparative dissolution testing.
The receiving site’s quality management systems must match the control level of the original facility. Gaps create compliance risks that surface during inspections. Missing information creates deviations that extend timelines and delay market access.
Why 2026 Matters
Policy Changes on the Horizon
Trade negotiations and policy discussions scheduled for 2026 could reshape where pharmaceutical companies manufacture products. Proposed tariff structures, domestic manufacturing incentives, and supply chain security requirements are all under consideration. Products that are cost-effective to manufacture overseas today might face financial penalties or regulatory barriers in the next year.
The Urgency Factor
The timing creates urgency. Companies that identify contract manufacturing partners and build transfer capabilities before policy changes take effect can respond strategically. Companies that wait until regulations force action will face compressed timelines, limited partner options, and higher costs.
Speed matters when policy changes hit, but speed without preparation creates bigger problems. The most efficient transfers involve receiving sites with deep expertise in specific drug delivery platforms.
What Experience Brings
A partner that has manufactured millions of transdermal patches or buccal films brings process insights that shorten troubleshooting and reduce iterations. They’ve seen coating formulations that look identical on paper perform differently on dissimilar equipment. They know which process variables need tight control and which have wider tolerances. They have in-process testing protocols to identify successful product quality attributes in real time. This experience lets them spot potential issues during planning rather than during validation, when fixing problems becomes far more expensive.
For companies preparing for potential 2026 policy changes, partners with drug-delivery expertise and commercial-scale production capabilities provide a path to market that reduces technical risk and timeline uncertainty.
How to Build Transfer Capabilities
Start With Early Collaboration
Successful technology transfer starts with early collaboration between technical teams. Before documentation is finalized, technical staff from both sites work together to identify which process parameters matter most, which quality attributes need tight control, and where equipment differences might create problems.
Transfer the Tacit Knowledge
Site visits let original site personnel demonstrate techniques and explain their decision-making in real time. They can point out visual cues and equipment quirks that never make it into batch records. Joint batches give both teams a chance to discuss what they’re seeing and why it matters.
Transfer protocols that work, document the development history, including failed experiments that identified constraints. They explain why specific parameters were chosen and how they interact.
Validate Properly
Process validation proves the receiving site can execute the manufacturing process and handle routine variability. The validation protocol should test the process within its standard operating ranges to confirm controls work as intended and the site can manage normal fluctuations without escalation.
Conclusion
Batch records capture what to do. They don’t capture why it matters, how operators recognize problems, or which variables interact in ways that only become visible during manufacturing. That information exists with the people who developed the process or with the experienced operators who have a history of manufacturing the product.
With policy changes potentially taking effect in 2026, companies building transfer capabilities now can respond quickly if regulations force manufacturing relocations. Beyond policy uncertainty, transfer readiness protects against supply chain disruption from regulatory action against current manufacturers or unforeseen catastrophic events. They maintain market access while competitors struggle with urgent transfers under compressed timelines. The difference comes down to preparing now instead of scrambling later.
ARx is a patient-friendly, novel drug delivery partner. We specialize in oral thin film, buccal film, topical and transdermal patch strategies—all backed by tailored, full-scale development services. Contact us today to discuss your technology transfer timeline.
