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CASSS Northern California Regional Forum Fall 2017: Scientific Program
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To view the final program, click here

Program Abstract

The CASSS Northern California Regional Forum is committed to bringing job-relevant education and regulatory trends for biopharmaceuticals to CASSS members through meeting programs. The October forum will focus on understanding Antibody Drug Conjugates (ADCs) and Bispecific Monoclonal Antibodies (mAbs) and the unique challenges these molecules present during product development. The discussion will include content from other regional, national or international forums organized by CASSS and speakers from industry and FDA. The program will also provide a platform for networking with both peers and regulatory authorities.


Learning Objectives: 

1. Discuss current CMC development FDA challenges, trends and expectations for ADCs and Bispecifics with industry and FDA colleagues.

2. Learn industry best practices in overcoming development and regulatory challenges for ADCs and Bispecific mAbs.   Key areas of focus will include:

a.    Process development experiences and challenges in the conjugation chemistry for ADCs.

b.    Formulation, stability, and analytical method / characterization challenges with ADCs.

c.    Analytical method / characterization challenges in the development of Bispecifics Antibodies

d.    Control strategy considerations for Bispecific antibodies and ADCs.





Advancements in ADC Manufacture and Control

Nathan Ihle, Seattle Genetics, Inc.
Click here to view the slides from this presentation.


Antibody-drug conjugates (ADCs) have established themselves as an important new class of biotherapeutics. The pipeline of ADCs in clinical development or on the market has grown steadily, and with this experience, developers have built a better understanding of the criticality of quality attributes and manufacturing steps, and the most effective ways to establish controls. Examples of controls that have been effectively used will be presented, along with thoughts about how these strategies could be adapted as products mature, and how current experience could influence future control strategies. 



Antibody Discovery and Bispecific Design: Development

Aaron Sato, LakePharma, Inc.
Click here to view the slides from this presentation.


Using an array of antibody discovery technologies, anti-target binding pairs can be discovered for incorporation into a bispecific. In this process, different constructs as well as developability criteria need to be employed. This presentation will review this process towards developing a molecule that can move towards the clinic.



A Regulator’s Perspective on Challenges in the Development of Antibody-Drug Conjugates and Bispecific Antibodies

Marjorie Shapiro, CDER, FDA
Click here to view the slides from this presentation.


Monoclonal antibodies are the most successful class of biological products, with an increasing number of approvals in recent years, including three antibody-drug conjugates (ADCs) and 1 bispecific antibody (BsAb). ADCs and BsAbs are also an increasing proportion of the antibody-related products entering clinical development. The complexity of these constructs adds additional development, manufacturing analytical and regulatory challenges for sponsors and regulators. This presentation will describe FDA’s experience with ADCs and BsAbs.




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