Register for this webinar to hear a discussion about how the use of stage-appropriate tools can be employed to unearth potential issues in biological products.
June 28, 2021
The FDA recently approved the 100th monoclonal antibody (mAb) product for commercial use. In the 35 years since the first approval, monoclonal antibody therapies have become mainstream and their production is considered a routine, platform process. However, a high proportion of candidate therapeutic antibody drugs fail to come through early development and Chemistry, Manufacturing and Control (CMC) without challenges.
Despite the many years of experience in development, therapeutic antibodies may show less-than-ideal properties, leading to challenges at different stages of the development pathway, from early development through to downstream manufacturing and even pre-clinical and clinical studies. These can manifest in several ways from low production yields and inconsistent product quality attributes through to immunogenicity, safety and efficacy concerns. This webinar will focus on how to address these challenges, highlighting examples of where they have been overcome to de-risk early-stage CMC and delivery of clinical trials material.
Register for this webinar to hear a discussion about how the use of stage-appropriate tools can be employed to unearth potential issues in biological products. Focus will be given to early awareness of such issues to give scope for removal through re-engineering or, if they are critical to function and cannot be avoided, help inform process design and control strategies using quality-by-design (QbD) principles. Both approaches lead to the same end goal of a de-risked molecule that will ultimately reduce development timelines.
For more information, or to register for this event, visit Early Therapeutic Antibody Development: Addressing the Challenges to Expedite a CMC Program.
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