Registration Open for Themed Salon: 'Safeguarding Biopharmaceutical Quality and Safety'
BRC BIOTECHNOLOGY
Biosafety Testing Service Provider
ALIOTH
Process Support Technology Product Developer
Safeguarding the Quality and Safety of Biological Products
Antibody Drug Enterprise Tour
Organizer：BRC BIOTECHNOLOGY, ALIOTH
Organizer：VCBeat Pharma
Supporting Organizations：Shandong International Biotechnology Park
Event Time:May 31, 2024 (Friday) 13:30
ActivityLocation:Shandong International Biotechnology Park, Yantai, Shandong Province
The quality of biopharmaceuticals has always been a crucial guarantee for maintaining health and safety. By strictly adhering to regulatory requirements while maximizing production efficiency, and by employing advanced technologies for quality testing, both the biopharmaceutical industry and regulatory bodies benefit. In the new era of pharmaceutical economics, the trend toward localization has gained significant momentum. We remain firmly rooted in China while keeping a global perspective. BRC BIOTECHNOLOGY’s biosafety testing services, together with ALIOTH’s filtration solutions, are dedicated to providing you with an entirely new experience in process development, regulatory compliance, and quality control.
Based on this, byCo-hosted by BRC BIOTECHNOLOGY and ALIOTH, and organized by VCBeat New Medicine, the [Safeguarding the Quality and Safety of Biological Products] Antibody Drug Enterprise Tour will be held in Yantai on May 31 (Friday).Shandong International Biotech Parkheld.
Shandong International Biotech Park – Actual View
Message from the Organizer
We sincerely welcome colleagues from Shandong’s pharmaceutical community to participate in this “Corporate Visit” event. As one of China’s key pharmaceutical industry hubs, Shandong has been chosen as the debut location for BRC BIOTECHNOLOGY’s “Corporate Visit” initiative, reflecting our desire to draw upon the province’s profound expertise and accumulated experience in the pharmaceutical sector. Let us engage in meaningful exchanges and co-create a promising future. As an emerging enterprise specializing in quality and safety testing for biopharmaceuticals in China, BRC BIOTECHNOLOGY adheres to the principles of rigor and objectivity, aiming to bring a fresh perspective to Shandong’s burgeoning biopharmaceutical industry.
——Wang Xin
BRC BIOTECHNOLOGYChief Strategy Officer
Shandong Province boasts a long history in the pharmaceutical industry, with China’s first GMP-compliant tablet production workshop established there in 1992. Currently, Shandong’s pharmaceutical sector spans multiple segments, from traditional chemical drugs to innovative biologics, accounting for over 10% of the national pharmaceutical industrial output value. As a provider of pharmaceutical filtration process solutions specializing in “membrane technology,” ALIOTH is honored to leverage this “Corporate Visit” initiative to engage with Shandong’s pharmaceutical companies. We aim to discuss the latest locally developed filtration technology products, share interpretations of the most recent regulatory guidelines on filtration processes, and support domestic substitution, cost reduction, and efficiency enhancement for pharmaceutical manufacturers, thereby contributing to the development of new quality productive forces in Shandong’s pharmaceutical industry.
——Jia Qijun
ALIOTHFounder & CEO
Highlights
Compliance:Assessments conducted in accordance with regulatory requirements, manufacturing processes, and product specifications serve as the core basis for drug quality.
Legality:Achieving Control of Exogenous Contamination in Biopharmaceuticals Through Effective Process Design and Facilities
Suitable:Establish sensitive and accurate detection methods to ensure the safety and stability of production processes and pharmaceutical products.
Event Agenda
■ 13:30-13:35 Opening Remarks by the Moderator
Moderator | Event Expectations and Collaborative Support
■ 13:35-14:05 Keynote Speech 1 -- ALIOTH
Study on the Removal of HCP and HCD by Depth Filtration in Antibody Purification
HCP and DNA Hazards in Antibody Manufacturing Processes and Regulatory Requirements
Strategies for the Removal of HCPs and DNA
Study on the Removal of HCP and DNA by Depth Filtration
■ 14:05-14:35 Keynote Speech 2 -- BRC BIOTECHNOLOGY
Testing Requirements and Regulatory Standards for Antibodies in the BLA Stage
Batch Release of Commercialized Antibody Products
Key Considerations for PSQ Testing of Commercialized Antibody Products
■ 14:35-15:05 Antibody Drug Companies Topic
■ 15:05-15:25 Tea Break and Riddle Interaction
■15:25-15:55 Keynote Speech 3 -- ALIOTH
Regulatory Developments and Interpretation of Sterile Filtration Technology and Its Applications
Regulatory Development and Overview of Sterile Filtration
Discussion on the Management Application and Practice Based on Regulations and Guidelines
Summary of Self-Inspection Points for Sterilizing Filtration Processes
■15:55-16:25 Keynote Speech 4--BRC BIOTECHNOLOGY
Key Points in Biosafety Testing of Antibody Drugs and Regulatory Differences Among China, the US, and Europe
Compliant Use of Antibody Drugs
Integrated Solution for Biosafety Testing of Antibody Drugs
■ 16:25-16:55 Expert Topic
■ 16:55-17:05 Host's Summary + Lucky Draw + Group Photo
Event Scale: 50 people/session
Event Registration:
Capillary 17782369627 (WeChat ID same)
