Tech Transfer Considerations

Pharmaceutical Technology® spoke with Ahmed Youssef, senior manager, USP Process Development at Ascend, to get his input on how tech transfer may be complicated when dealing with emerging therapies, such as antibody-drug conjugates, cell and gene therapies, and patient-centric treatments. Youssef pointed to timing as being key for technology transfer.

“It takes an innovator around 12 to 24 months to make a product ready, tech transfer it, [and] complete the safety studies for it,” says Youssef. “But there could be other solutions that could be offered in the background that could make this more efficient, faster, and more attractive to product developers.”

When it comes to sponsors and contract organizations working together to ensure a secure tech transfer, Youssef says the contract development and manufacturing organization (CDMO) should shoulder the responsibility. “A good CDMO [should] have structured communication, because communication is key … when you're talking to your business partner. We always build that in a more collaborative environment,” says Youssef. “[A CDMO needs] to protect the IP rights of their clients, their partners, as well as good documentation practices, in addition to a solid IT department. All of that gives the assurance to the security of the data and the security of the transfer information between the CDMO and their partner.”

Youssef also gave his insights on how sponsors can benefit when contractors offer end-to-end services. “If you mean by end-to-end, the whole process, you know, without the whole offering, from the start of plasmid manufacturing till commercial manufacturing of the batches, and then the fill and finish and release, understand that the advantage would be that you're running all of that under one MSA [master supply agreement], one big MSA,” said Youssef.

Click the video above to watch the interview.