KBI Biopharma

KBI Biopharma
Dr Abhinav Shukla
Sr. VP, Process Development and Manufacturing
" Abhinav has over 15 years of experience in process development in biopharmaceuticals covering early development through commercial launch. He has led process development activities at both small biopharmaceutical and large pharmaceutical organizations and was most recently the Director, Manufacturing Sciences and Technology at Bristol-Myers Squibb. At BMS, Abhinav led an organization that successfully commercialized Yervoy® and Nulojix® and provided post-commercial process support for Orencia® in addition to other late-stage programs. "

1. What do you think has been the biggest achievement within the antibody sector in the last 12 months?

No radically new development in the last 12 months, but there is a clear differentiation emerging in this space as companies start to focus on variants of the mAb theme such as bispecific antibodies (bsAbs) and antibody fragments.

2. What important points do you hope to convey at the congress, and what information can you give me now that delegates can look forward to?

That platform processes have really transformed the industry's approach to mAb development. Each company has its own version of a platform process based upon the type of mAb construct they take forward, their expression system and cell culture process. CDMOs like KBI have to develop a more generic platform since it has to be able to handle many different mAb types and be compatible with many different expression systems. My talk will describe some of the leading mAb platforms and delve deeper into KBI's mAb platform.

3. What do you think will be the biggest topic of discussion at this November's European Antibody Congress?

How to transition assets from early clinical development to commercial launch.

4. What do you think will be the take home messages from the congress?

Platforms work and are great, can be established for mAbs and extended into other mAb variants and form a continuum between early clinical development and commercialization.

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