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In the first part of an extended video interview, Petra Dieterich and Jeffrey Mocny of Abzena emphasize to Biopharm International editors that every step in developing novel biologics is designed to bring them to humans not just quickly but also safely.
As a contract development and manufacturing organization (CDMO), Abzena works with its partners to get molecules into the clinic and into first-in-human studies, then through the requisite regulatory stages to get drugs to market for patients.
Where novel and challenging conjugates are concerned, parts of that process may take a certain amount of time—and time is everything in a competitive environment.
In this video interview, which is presented here in the first of three parts, Abzena’s Petra Dieterich, PhD, senior vice-president and scientific leader, and Jeffrey Mocny, PhD, scientific lead, talk about those challenges and the knowledge that is needed for a CDMO to overcome them and provide representative service to customers.
“It’s having the experience to know what is required, having the scientific knowledge and skill sets available to make that happen,” Dieterich says in the interview. “And then, of course, it’s multidisciplinary. We’re not just talking chemists. We have to have biologists on board. We have to have bioconjugation scientists on board. We mustn’t forget analytical; we have to have the right analytical support. That can be complicated.”
Mocny agrees, saying that all of these elements need to come together from day one of a partnership.
“We like to get that right up front,” he adds. “Measure twice, cut once. Naturally, programs evolve with time, as the markets shift and competitor molecules come on market and treatment paradigms change, but the overarching goals need to be continuously revisited.”