Monoclonal antibody-like molecules, including bi- and tri-specifics, Fc-fusion proteins and antibody-drug conjugates, have become prominent as the next generation therapies in development. These designs can generally take advantage of the manufacturing processes established for mAbs albeit each still has its own nuances around control strategies, as will be examined further in this forum. What else is out there besides these mAb-like constructs, and what does their manufacturability look like? And what about their CQAs and control strategies?

In this session, we will explore new innovations in molecular designs and scaffolds outside of the realm of traditional mAbs. In addition to recombinantly derived biologics, possibilities may also include a combination of chemical and biological approaches, such as protein conjugates and even synthetically derived molecules. A variety of new modalities ranging from novel (fusion) proteins to antisense oligonucleotides will be discussed.

While development is ongoing and success may be somewhat unknown at this time, each example will shed light on the benefits of their design, CMC issues, immunogenicity risks and regulatory landscape. The topics covered will give us a glimpse into the endless possibilities of future molecular constructs that may be entering clinical development.

Session Speakers:

09:05 - 09:30
Process Development in the Age of Multispecifics and Novel Modalities
Jennitte Stevens, Amgen Inc.
09:30 - 09:55
Novel Modalities May Warrant Novel Product Quality Controls
Deborah Schmiel, CDER, FDA
09:55 - 10:20
Analytical Challenges and Solutions For an Orally Delivered Single-Domain Antibody (VHH/Nanobody)
Bingchuan Wei, Genentech, a Member of the Roche Group
10:20 - 10:45
Analytical Control Strategy for Antisense Oligonucleotide
William Zhang, Biogen

Deborah Schmiel

Appearances