Preparing for your Clinical Batch | CDMO Insights скачать в хорошем качестве

Preparing for your Clinical Batch | CDMO Insights

Preparing to fill clinical material for your trial As you take the next step to in-human trials, your focus is on getting your molecule to the clinic as quickly and efficiently as possible – with a secure supply of product for your trial. For an injectable medication, filling a batch of clinical material is a critical step in that process. As clinical manufacturing expert Garath Duffy explains, that process can be an anxious one for teams releasing their molecule from the R&D environment for the first time. As he says, “for a lot of customers, their molecule is really like their baby. They’ve been nurturing it in their lab environment for so long, in miniscule volumes. There it was all about understanding the molecule. Now it’s about not only producing significantly more of that drug product, but also developing a high quality, scalable filling process that meets all safety and quality requirements for in-human use.” Budgets, timelines, and future funding goals often further increase the pressure to get everything exactly right on the first clinical filling run. With clinical and financial milstones on the line, parenteral drug developers need to take a smart, strategic approach to filling their clinical trial material – one that not only streamlines their transition to the clinic but also sets the stage for additional downstream successes.