The Art and Science of Getting Tech Transfer Right First Time

By Dipak Gordhan & Nathan Collingwood, Upperton

The reality of technology transfer is usually more complex than it sounds.

Tech transfer is often defined as the movement of a process from one stage of development to another, or from one manufacturing site to another.

Sounds simple enough?

However, successful technology transfer requires the integration of scientific understanding, manufacturing expertise, quality considerations and regulatory requirements to ensure that a product can be produced consistently at the required scale. That’s where the challenge comes in.

At Upperton, technology transfer sits at the intersection of development and manufacturing. It bridges the gap between formulation development, scale-up and GMP production, ensuring that the knowledge generated during development can be translated into robust, reproducible manufacturing processes capable of supporting clinical and commercial objectives.

Technology Transfer Is More Than Data Transfer

One of the most common misconceptions about technology transfer is that it is primarily an exercise in documentation. While reports, batch records and manufacturing instructions form an important part of the process, technology transfer is fundamentally a knowledge-driven activity.

The objective is not simply to move data from one team to another. It is to understand how a product behaves, identify the critical process parameters that influence performance, and ensure that this knowledge can be applied consistently at larger manufacturing scales.

This can take several forms. In some cases, a product is developed internally and transferred from formulation development into GMP manufacturing. In others, a client may have already established a process at another facility and require transfer to a new manufacturing site.

Both scenarios involve the same challenge: preserving scientific understanding while adapting the process to a new environment.

Scaling from Development to GMP Manufacturing

A key aspect of technology transfer is scale-up.

Processes developed at laboratory scale are rarely suitable for direct implementation in a GMP manufacturing environment. Equipment configurations, operating parameters and material handling approaches can differ significantly between development laboratories and manufacturing facilities.

For example, a formulation that has been produced using small-scale research development equipment must ultimately be manufactured using large scale equipment. Similarly, a spray drying process developed on laboratory equipment may require transfer to larger-scale industrial spray dryers while maintaining critical product attributes.

The challenge lies in ensuring that product quality and process performance remain consistent throughout this transition.

Technology transfer teams therefore evaluate development data, understand the rationale behind process parameters and determine how these parameters can be adapted to larger-scale equipment. This process often involves experimental studies designed to establish operating ranges, assess risk and confirm scalability.

The end goal is a process that is technically robust, manufacturable under GMP conditions and suitable for regulatory submission.

The Critical Importance of Knowledge Transfer

While scale-up is often considered the technical challenge of technology transfer, knowledge transfer is frequently the determining factor in overall success.

The quality of information available during transfer directly influences the quality of the decisions that can be made.

When transferring externally developed processes, access to comprehensive development reports, manufacturing records, analytical data and process histories significantly improves the chances of a successful outcome. Equally valuable is information relating to unsuccessful development studies or failed batches. Understanding what did not work can be just as important as understanding what did.

Without adequate transparency, teams are often forced to make assumptions, increasing technical risk and potentially extending development timelines.

The same principles apply internally. When transferring a product from formulation development into GMP manufacturing, regular interaction between development scientists, technical transfer specialists and manufacturing teams is essential. These discussions provide context that cannot always be captured within formal documentation and help ensure that critical process understanding is retained throughout the programme.

Building Scale-Up into Development from the Beginning

Effective technology transfer does not begin at the point of manufacturing. It begins during development.

Early engagement between development teams and technical transfer specialists helps ensure that scalability is considered from the outset. Decisions made during formulation development can have significant downstream implications for manufacturing feasibility.

This includes evaluating whether raw materials are commercially available, whether excipients are suitable for GMP use, and whether the process can realistically be reproduced within a cleanroom environment.

A formulation may perform exceptionally well at laboratory scale, but if key materials cannot be sourced consistently or if process steps cannot be replicated at larger scale, significant redevelopment may be required later.

By involving technical transfer teams early, potential barriers can be identified and mitigated before they become critical programme risks.

A Structured Approach to Internal and External Transfers

Although every programme is unique, technology transfer activities typically follow a structured framework.

For internally developed products, knowledge transfer begins with formal handover activities between development and manufacturing teams. Development reports, process data and experimental findings are reviewed in detail and used to build a scale-up strategy.

Cross-functional planning meetings allow teams to challenge assumptions, assess risks and define manufacturing approaches before GMP activities commence. Importantly, development scientists remain involved throughout the transfer process to provide continuity and ensure that product behaviour remains consistent as scale increases.

For externally transferred products, the process begins with a detailed assessment of the client’s existing process and manufacturing history. Information relating to materials, equipment, process parameters and analytical performance is reviewed to identify potential knowledge gaps and areas of risk.

This information is then used to develop transfer protocols, manufacturing instructions and scale-up strategies. Experimental studies are conducted where necessary to confirm process understanding and demonstrate compatibility with the new manufacturing environment.

Throughout both approaches, the objective remains the same: develop sufficient process understanding to enable predictable GMP manufacture.

Using Data to Reduce Risk

Technology transfer generates significant amounts of process data. The ability to effectively analyse and interpret that data has become increasingly important.

Modern statistical tools and Design of Experiments (DoE) methodologies allow teams to evaluate process performance more systematically than ever before. Rather than simply confirming that a process works, these approaches help identify relationships between process parameters and product quality attributes.

This deeper understanding improves process robustness and helps identify potential risks before they become manufacturing issues.

The output from these studies informs recommendations for GMP manufacture, supports regulatory submissions and contributes to the establishment of long-term process control strategies.

Ultimately, data-driven decision making allows organisations to move beyond simple scale-up and develop a more comprehensive understanding of process behaviour.

The Role of Cross-Functional Collaboration

Technology transfer cannot operate in isolation.

Successful programmes require close collaboration between development scientists, manufacturing specialists, quality teams, analytical scientists and programme managers. Each group contributes expertise that influences the overall success of the transfer.

Programme management plays a particularly important role in coordinating activities across functions, ensuring that technical decisions align with project timelines, resource requirements and development objectives.

At the same time, technical transfer teams provide the scientific and operational insight needed to establish realistic plans and identify potential challenges.

The result is a collaborative model where project execution is driven by technical knowledge rather than driven solely by deadlines.

Are Processes or People More Important?

A common question within technology transfer is whether success depends more on processes or people.

The reality is that both are essential.

Robust processes provide structure, consistency and compliance. They ensure that activities are conducted in accordance with GMP requirements and establish clear pathways between development and manufacturing.

However, processes alone cannot replace experience.

Successful technology transfer relies heavily on individuals who understand formulation development, scale-up science, manufacturing operations and regulatory expectations. These individuals apply scientific judgement, interpret complex datasets and solve the unforeseen challenges that inevitably arise during product development.

The strongest technology transfer programmes combine both elements: experienced people operating within well-defined processes.

Technology Transfer as an Enabler of Clinical Success

At its core, technology transfer is about ensuring that promising therapies can progress successfully from development into clinical manufacture.

Achieving this requires more than equipment matching or documentation reviews. It requires detailed process understanding, rigorous planning, effective knowledge sharing and continuous collaboration between technical teams.

When executed effectively, technology transfer reduces development risk, accelerates manufacturing readiness and creates a strong foundation for future clinical and commercial success. Most importantly, it ensures that critical knowledge remains intact as a product moves through each stage of its development journey, allowing innovative therapies to reach patients efficiently and reliably.

Dipak Gordhan is Associate Director of Manufacturing Operations at Upperton. He has worked in the pharmaceutical industry since 2013, with experience spanning formulation development, clinical manufacturing, technology transfer and commercial readiness. He has supported products from early development through clinical trials and commercial manufacture for markets in Europe and the U.S., with previous roles at Aesica and Juniper, later Catalent.

Nathan Collingwood serves as Principal Scientist at Upperton, where he specializes in technical transfer and scale-up of pharmaceutical dosage forms from development into clinical manufacture. He holds a degree in Chemistry from University of Glasgow and brings more than a decade of both hands-on lab experience and manufacturing insight to his work. In his role he guides analytical method transfer, and process implementation for early-to-late-stage clinical programs.