Sponsored Content by EvotecReviewed by Emily MageeJul 22 2026
The manufacture of cell-based therapies is inherently complex, but these therapies offer significant potential to cure a wide range of diseases.
Image Credit: Shutterstock.com/Anusorn Nakdee
Transferring the manufacturing process from the development stage to a GMP manufacturing facility (often through an external partner) for a first-in-human clinical trial is one of the most challenging steps in the progression from early development to commercial production.
This step is especially important for small biotech companies because it requires considerable resource commitments in terms of personnel and finances, along with successful cooperation between manufacturers and partner companies over several years.
A new whitepaper from Evotec explores the key role of technology transfer activities and aims to help early developers navigate these manufacturing transitions.
Challenges and considerations are assessed, alongside the steps needed to ensure the successful transfer of process and product knowledge between facilities and teams to support a first-in-human study.
Technology transfer and its role in the drug product lifecycle
Technology transfer, or “tech transfer” as it is often referred to, is a key component of drug development and manufacturing.
Tech transfer involves transferring the cell-based product’s manufacturing process and its related analytical methods from the biotech company, referred to as the sending unit (SU), to the external partner, the receiving unit (RU). In this context, the RU is generally a contract development and manufacturing organization (CDMO).
Successfully undertaking the tech transfer process maintains consistency with the SU’s procedures by ensuring that all manufacturing and analytical processes are accurately reproduced at the RU.
Tech transfer seeks to ensure alignment with regulatory filings such as marketing authorizations or clinical trial applications, safeguard product quality, and adhere to applicable GMP and other regulatory requirements.
The ICH guideline Q10 on pharmaceutical quality systems states that:
"The goal of tech transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement."
Figure 1. Technology transfer points throughout drug development and manufacturing, ensuring a smooth progression from preclinical development to commercial production. Image Credit: Evotec
Tech transfer is central to several stages of the drug product lifecycle, underpinning and facilitating the transition from development to GMP manufacturing for initial clinical supply.
It may be necessary to conduct additional tech transfers during later development phases and at market entry, for example, when offering the product in different regulatory regions or scaling product supply.
Challenges faced during the tech transfer of a cell therapy product
Developers regularly face major challenges when transferring manufacturing processes for cell-based products between organizations. For example, it can be difficult to ensure appropriate regulatory compliance and maintain product quality while adapting processes.
The use of research-grade raw materials remains a common issue because higher-quality alternatives remain scarce. This could necessitate additional testing to ensure consistent quality or the implementation of material substitutions during tech transfer.
In addition, equipment often varies among developers because standardized platform processes remain limited. Tech transfer may therefore require integrating a new device at the CDMO or switching to an alternative, both of which entail significant effort.
Cell-based products also tend to rely on distinct analytical assays, and these assays may be challenging to implement and validate at the RU.
Cell therapy manufacturing typically relies on manual processing steps, potentially necessitating longer periods in a cleanroom environment versus operations in a development laboratory.
The extended processing time in this scenario may also require reassessing the in-process stability of cell-based intermediates to ensure their viability and quality are maintained throughout the longer handling period.
Tech transfer in cell therapy faces a range of complexities, demanding substantial labor, materials, time, and cost. It is imperative that a successful transfer be ensured, however, because poor execution has the potential to compromise patient safety and product quality.
Evotec’s new whitepaper outlines the key steps for a successful tech transfer, from initial planning through to completion, helping developers better navigate these challenges.
About Evotec
Evotec’s mission is to discover and develop highly effective therapeutics and make them globally available to the patients who need them. To this end, Evotec has established itself as a global platform company, leveraging its data-driven multimodality platform for both proprietary as well as partnered research, and applying a unique combination of innovative technologies for the discovery and development of first-in-class and best-in-class pharmaceutical products. Its network of partners includes all Top 20 Pharma and hundreds of biotechnology companies, academic institutions, and other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including, e.g., neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and make them accessible to patients worldwide. To-date, the Company has established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development.
Evotec operates globally with more than 4,500 highly qualified people at 17 sites in six countries across Europe and the USA. The Company’s sites in Hamburg (HQ), Cologne, Goettingen, Halle/Westphalia and Munich (Germany), Lyon and Toulouse (France), Abingdon and Alderley Park (UK), Modena and Verona (Italy), Orth (Austria), as well as in Branford, Princeton, Redmond, Seattle and Framingham (USA) offer highly synergistic technologies and services and operate as complementary clusters of excellence.
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