The rise of Advanced Therapy Medicinal Products (ATMPs) is reshaping modern medicine—bringing new hope to patients with hard-to-treat cancers, genetic diseases, and autoimmune conditions. But as these therapies move from discovery to delivery, one critical hurdle often determines success: technology transfer.

For companies scaling up or globalizing their cell or gene therapy programs, tech transfer isn’t just about documents and protocols. As Bramble Bio outlines in their recent case study, it’s about collaboration, trust, and navigating a web of biological, logistical, and regulatory complexity.

 

Why ATMP Tech Transfer Is Unlike Anything Else

ATMPs are living products. That means they’re sensitive, variable, and often hand-processed—making them fundamentally different from traditional drugs. As Bramble Bio explains, the process of transferring production from one site to another, particularly to or from a CDMO, is a deep, hands-on reconstruction of the manufacturing system—not a plug-and-play handover.

Even subtle changes in cleanroom setup, equipment models, raw material sourcing, or operator technique can significantly impact product quality. That’s why Bramble Bio advocates for a highly tailored, cross-functional approach, where quality, production, and regulatory experts work together from the outset.

 

Bramble Bio’s Perspective on the Key Challenges

1. Infrastructure Doesn’t Always Translate
Bramble Bio notes that even with well-characterized protocols, local differences in utilities, cleanrooms, and equipment mean manufacturing processes must often be revalidated. Early assessment of site capabilities is crucial.

2. Biological Materials Add Pressure
With ATMPs, the raw materials—often living donor cells—are fragile and variable. Bramble Bio emphasizes the importance of robust logistics planning, tight cold chain control, and early engagement with CDMO partners to preserve material integrity.

3. Analytical Transfer is a Minefield
ATMPs rely on non-compendial assays that rarely transfer easily. Bramble Bio recommends incorporating analytical strategy from the start and selecting CDMOs with the in-house expertise or established third-party networks to support assay validation and harmonization.

4. Regulations Vary Across Borders
Whether it’s EU Qualified Person (QP) requirements or U.S. donor eligibility criteria, navigating international regulations can stall even the most promising program. Bramble Bio’s case study highlights the value of working with CDMOs who understand these nuances and can pre-emptively manage gaps in documentation, traceability, or compliance.

5. Tacit Knowledge is Often the Missing Link
One of Bramble Bio’s key insights is that many ATMP processes rely on manual steps, and the "unwritten" know-how of experienced operators is critical. Without structured training and collaborative manufacturing runs, knowledge transfer breaks down—and so does consistency.

 

Bramble Bio’s Best Practices for Seamless Transfers

To overcome these hurdles, Bramble Bio recommends the following strategic steps:

• Engage Early: Involve your CDMO in scaling conversations from day one to avoid late-stage surprises.

• Plan Realistically: Set timelines that account for method transfer, operator training, and comparative manufacturing runs.

• Align Analytically: Transfer assays alongside manufacturing processes, with inter-lab validation built in.

• Collaborate on Docs: Reduce ambiguity and ensure regulatory alignment by jointly developing key documentation.

• Shadow and Train: Hands-on operator training and shadowing are non-negotiable for ATMP reproducibility.

• Run Bridging Studies: Pilot batches can uncover variability before formal validation—saving time and cost.

• Choose the Right CDMO: According to Bramble Bio, your manufacturing partner isn’t just a vendor—they’re your guide through regulatory terrain, technical hurdles, and logistical unknowns.

 

Final Thoughts: Partnering with Bramble Bio

In ATMP manufacturing, the process is the product. That’s why technology transfer must be managed with scientific precision, strategic foresight, and operational excellence. Bramble Bio doesn’t just help clients hand over their processes—they help them safeguard their therapy’s potential by asking the right questions early, building bridges between teams, and ensuring every variable is accounted for.

Whether you’re preparing for your first clinical batch or expanding across borders, Bramble Bio brings the experience, structure, and collaborative mindset needed to make your tech transfer a success—not a setback.

Read more: PDF Article Case Study

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