Technology Transfer Protocols

The True Cost of Failed Gene Therapy Tech Transfers Ever wondered why some gene therapy tech transfers fail while others soar? After an illuminating panel discussion with industry titans Praveen Prasanna, Vibhav Patel, and Louis Garguilo, here's what keeps me up at night - and why it should matter to you: The Hidden Risk Factor: The success of your tech transfer isn't just about documentation - it's about what's NOT being said. One missing detail can derail your entire timeline, directly impacting patient access to life-saving treatments. Here's what 15+ years in the field has taught me about bulletproof tech transfers: 1. Risk Assessment Framework   - Map sender capabilities against receiver facilities   - Score risks systematically through FMEA   - Standardize evaluation unit-by-unit, equipment-by-equipment 2. Critical Success Factors:   - Assay transfer compatibility   - Equipment matching strategy   - Risk mitigation vs. acceptance decisions 3. The Game-Changer: True collaboration with your CDMO isn't optional - it's the difference between success and setback. Without complete transparency, you're building on shifting sands. Key Takeaway: Your tech transfer strategy is only as strong as your weakest link. In gene therapy, where patient lives hang in the balance, "good enough" isn't good enough. Question for my network: What's your most valuable lesson learned from a tech transfer gone wrong? Share your insights below. #GeneTherapy #Biotech #TechTransfer #CDMO #BioProcessing #BioPharma #Innovation #PatientCare --- Inspired by insights from an engaging panel discussion with Praveen Prasanna, Vibhav Patel (University of Minnesota), and Louis Garguilo on CDMO selection and tech transfer excellence. https://lnkd.in/ehVc7-tQ

Tech transfer is one of the riskiest, most misunderstood phases in biomanufacturing. It’s not just about moving a process - it’s about translating tribal knowledge into precision execution. Here’s what’s broken with how most CDMOs do it: Process data lives in a graveyard of PDFs, Words, process diagrams and email threads. Critical steps are ambiguous. And by the time you realize something was lost in translation, you’re troubleshooting a failed batch. Here’s how AI agents changes the game: 1/ Semantic understanding of scientific documents - LLMs can parse tech transfer packages and SOPs to identify inconsistencies, undefined parameters, or gaps in logic. - It’s like giving every engineer a digital co-pilot that knows how to spot missing buffer pH values or ambiguous step durations. 2/ From tribal knowledge to standardized templates - Instead of starting from scratch, AI can auto-generate draft protocols and batch instructions based on past successful transfers. - This reduces reliance on memory and speeds up documentation. 3/ Continuous validation across sites and scales - LLMs can compare past transfers of similar molecules, flag deviations in execution, and help prevent scale-up surprises. - This isn’t just automation, it’s institutional memory. 4/ Faster tech transfer = faster to clinic or market - Every week saved in tech transfer accelerates launch timelines. - AI helps teams move faster, with even enhanced quality. In a world where regulatory precision meets operational chaos, AI that understands process documentation isn’t a nice-to-have.   It’s essential infrastructure.

Technology Transfer in Biopharma – Why It Fails More Than It Should Tech transfer is the bridge between discovery and delivery. Yet almost half of transfers in biopharma face delays or quality issues. Why? It’s rarely due to science. it’s often due to systems, silos, and assumptions. In Part 1 of my new article, I explore the operational foundations of successful transfers, and what too many teams miss. 🔍 3 Takeaways: 1️⃣ Regulatory mismatch is real -EMA and FDA expect the same principles, but enforce them very differently. 2️⃣ Digital systems are often the hidden bottleneck -MES, LIMS, and audit trail gaps cause post-transfer headaches. 3️⃣ “3 batches passed” isn’t enough  -You need statistical evidence, not just completion. “You don’t rise to the occasion. You fall to the level of your systems.” – James Clear 📖 Read Part 1 below. ♻️ Repost and share with your TT teams. 🧬 Coming next week → Part 2: ATMPs, Cell Therapy & Complexity at Scale Why cell and gene therapy tech transfers demand a different playbook. #TechTransfer #Biopharma #GMP #CellTherapy #ATMP #ICHQ10 #QualityMatters #Manufacturing #RegulatoryCompliance