BioPharm International: Conjugation and Regulation Challenges for Advanced Molecules: Part 2 of 3

In the first installment of a three-part interview, Petra Dieterich, PhD, senior vice-president and scientific leader, and Jeffrey Mocny, PhD, scientific lead, both of Abzena, discussed the know-how that a contract development and manufacturing organization (CDMO) must have to handle novel, challenging molecules.

Now, in part two of three of this video exclusive to BioPharm International®, Dieterich and Mocny get into more specifics about the types of molecules that CDMOs such as Abzena are trying to advance in the current biologics space—namely oligonucleotides (AOCs).

“They’re not very bioavailable,” Dieterich says in the interview. “They will need different analytical techniques to consider them, and while we can put them onto our conjugation platform, we have to pivot quite significantly when we’re talking about purification.”

As in the first portion of the interview, Mocny says this brings regulatory considerations as well.

“In the regulatory arena, while oligonucleotide therapies have been on market for some time, and there’s been regulatory guidance around how those molecules are manufactured in the aggregate, in the conjugate space, it’s a little less defined,” Mocny says. “So what we’ve worked very diligently on is to provide a platform or a thinking approach, to be able to get these large conjugate molecules that are novel in their therapeutic construct to comply with regulatory requirements.”

Dieterich also stresses the importance of getting the basics right; that Abzena has a strong platform from which to build, and so when more complicated molecules need to be dealt with, scientists know how to handle their peculiarities quickly and efficiently.

Click here to watch the interview with our experts