An Insider's Guide to Reaching a Right-the-First-Time Tech Transfer
Driven by complex modalities, global supply chains, and strategic partnerships, increased outsourcing makes tech transfer a critical process for both CDMOs and sponsors.
Tech transfer is an intricate undertaking–often a “you don’t know what you don’t know” situation for newcomers, and even a demanding data-gathering trial for those with experience. Working with an experienced CDMO can clarify the path forward.
In this series, Lifecore experts will consider what is at stake during tech transfer, why up-front work can save more than just time, and how the accumulated expertise of an experienced CDMO can guide sponsors toward success.
What’s at Risk If Tech Transfer Goes Wrong
Every tech transfer is unique in some way, and the consequences of getting details wrong can be significant. The greatest risk would be the inability to produce a safe, high-quality product–something no sponsor or CDMO could accept as an outcome. On the path to ensuring safety, quality, and compliance, ineffective or inefficient tech transfers involve additional risks, such as:
- Repeated development work if important information is missing or unclear.
- Regulatory scrutiny if the handover doesn’t clearly show how and why key decisions were made.
- Added time and expense, increased stress on resources, and elevated risk if there’s any misalignment from either side.
All of the above can delay a program’s next steps or even postpone a product launch.
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Knowledge Transfer:
Not the time to be coy
The Scale-Up Surprise:
When optimism meets reality
Equipment Assumptions:
The atmosphere is different here
Methods Matter:
Keeping in-transit methods intact
The Human Factor:
Creating good vibes from both sides
With a range of successful transfers from early-stage to commercial supply, the Lifecore team understands what it takes to transfer a project smoothly. We ensure that everyone is aligned on the process, the product, and the long-term goals. Our multi-disciplined team structure means project leads manage day-to-day work, identifying risks and escalating when needed; managers provide oversight and help to move decisions forward; and executives remain on hand to quickly provide higher-level guidance if required.
Plus, with deep experience in handling complex products, our technical experts are effective at addressing process development and manufacturing challenges throughout the transfer.
This article is part of Lifecore’s Technology Transfer Series. For the full picture on getting tech transfer right the first time, visit our Insider’s Guide to Right-First-Time Tech Transfer.
If you need help with tech transfer, contact us to explore how we could work together.