Transferring a biopharmaceutical process to a CDMO is a critical milestone in the life cycle of any biologic. Whether you are moving from R&D to GMP manufacturing or scaling up for clinical supply, a well-executed tech transfer can make the difference between smooth project advancement and costly delays.
At 53Biologics, we specialize in decoding biologics production, from amino acid sequence to GMP batches. Here are some essential tips to ensure a seamless process transfer and how we can help you every step of the way.
Start with a detailed data package
A comprehensive and well-organized technology transfer package is the foundation for success. It should include process descriptions, analytical methods, critical process parameters, and historical performance data. Sharing clear and complete documentation helps the CDMO replicate and understand your process effectively.
Involve your CDMO early
Engaging your CDMO during the development phase, not just at the moment of transfer, allows for smoother knowledge exchange. At 53Biologics, we offer process development services that ensure the process is robust, scalable, and ready for GMP production. All under one roof.
Align expectations on timelines and deliverables
Successful collaborations require clear communication. Setting mutual goals, realistic timelines, and understanding responsibilities from the beginning avoids misalignments later. Our project managers at 53Biologics act as dedicated partners, ensuring your milestones are met with transparency and efficiency.
Plan for risk and mitigate it
No tech transfer is without risk, but early identification of potential issues is key. At 53Biologics, we conduct risk assessments and use our extensive experience with enzymes, cytokines, vaccines, VLPs, mAbs,… to anticipate common pitfalls and proactively address them.
Trust your CDMO’s experience
Your CDMO should be more than a service provider, it should be a strategic partner. At 53Biologics, our team brings deep expertise in microbial expression systems like E. coli and Pichia pastoris, and we support projects from preclinical to GMP manufacturing.
We know that selecting the right CDMO is not an easy task. If you are at that stage, check out our article on How to Choose the Right CDMO Partner and learn more about The Value of a CDMO in the Pharma World.
About 53Biologics:
53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins. The company provide services from preclinical development to GMP manufacturing, supporting their clients in getting their biological products to market as quickly as possible.
For more information or to speak with one of our experts, fill out our contact form or email us at in**@53*********.com.
