USP에서 진행하는 Biologics 관련 무료 웨비나 강연 정보 입니다.

항체의약품 개발에 요구되는 분석법, QC 관련 현안 및 표준품 개발에 대한 제안 및 논의가 주내용이며, 아래의 사항으로 진행 예정입니다.

자세한 강연 내용은 아래 원문을 참고 부탁드립니다.

1. 강연제목: Analytical challenges for the development of monoclonal antibodies and USP Standards
2. 시간 : 2020. 07. 10 (금요일) 오후 3시
3. 강연 등록 하기 (링크 클릭) / 비밀번호 : abcde

   
   

   
   

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Greetings from USP!

The Biologics team of USP is excited to bring to you a virtual discussion forum on Analytical challenges for the development of monoclonal antibodies and USP Standards

Join the insightful discussion with the following experts:

1. Dr. Dhananjay, Vice President - Biologics & Pharmaceutical Development at Syngene International Limited.

2. Dr. Ranjan Chakrabarti, Vice President – Scientific Outreach, Biologics, USP

3. Dr. Annu Uppal, Sr. Scientific Affairs Manager, USP

4. Karthik Iyer, Director South Asia, Strategic Customer Development

Date and Time: 10^th July 2020, 11:30 AM to 12:45 PM (India),  (Singapore: 2pm | Korea: 3pm | China: 2pm)

USP is constantly engaged with stakeholders to better understand how the industry is evolving and what are their requirements. The Biopharma industry stressed their desire for standards that work with multiple analytical techniques so that they can be adopted easily. USP has dedicated significant expertise and resources towards developing new standards to give manufacturers more flexibility in choosing standards that fit their purpose and support the manufacturers to ensure quality and safety of their product.

USP has released 3 New monoclonal antibody reference standards which can be used as an independent control material for method development, training, method transfer, an internal assay control support, standardization of physio-chemical testing, such as intact mass, charge, heterogeneity, size variants, purity and glycan analyses

The session will have presentations covering the following topics:

1. Analytical and Quality challenges for the development of monoclonal antibodies.

2. Analytical methods and technologies for monitoring critical quality attributes (CQAs) throughout the product life cycle.

3. USP standards to support method performance and analytical testing of monoclonal antibodies.

4. Overview of new USP monoclonal antibody standards, to support analytical method development.

At USP, everything we do is in service of our mission to help protect and improve the health of people globally. We look forward to your participation and having an enlightening session that would benefit all.