Registration Open for 'Safeguarding Biopharmaceutical Quality and Safety' Industry Seminar in Chengdu
BRC BIOTECHNOLOGY
Biosafety Testing Service Provider
ALIOTH
Process Support Technology Product Developer
Safeguarding the Quality and Safety of Biopharmaceuticals
Biopharmaceutical Enterprise Tour · Chengdu Stop
Organizer：BRC BIOTECHNOLOGY, ALIOTH
SupportUnit：China Association of Enterprises with Foreign Investment, Biotechnology Innovation Working Committee
Organizer:VCBeat New Medicine
Event Duration:Friday, September 6, 2024, 13:00
Quality in biopharmaceuticals has always been a crucial safeguard for health and safety. While strictly adhering to regulatory requirements, we strive to maximize production efficiency and employ advanced technologies for quality testing, thereby benefiting both the biopharmaceutical industry and regulators. In the new era of pharmaceutical economics, localization trends have rapidly caught up. We remain firmly rooted in China while maintaining a global perspective. BRC BIOTECHNOLOGY, specializing in biosafety testing, joins forces with ALIOTH Filtration Solutions to deliver an entirely new experience in process development, regulatory compliance, and quality control.
Based on this, byCo-hosted by BRC BIOTECHNOLOGY and ALIOTH, with the support of the Biotechnology Innovation Working Committee of the China Association of Enterprises with Foreign Investment, and organized by VCBeat New Medicine, the [Safeguarding the Quality and Safety of Biological Products] Biopharmaceutical Enterprise Tour · Chengdu Stop will be held on September 6 (Friday)held.
Host's Message
We sincerely welcome colleagues from Chengdu’s pharmaceutical industry to participate in this “Corporate Visit” event. As a major pharmaceutical industrial base in China, Chengdu—known as the “Land of Abundance”—hosts BRC BIOTECHNOLOGY’s “Corporate Visit” series, aiming to draw upon the city’s profound experience in the pharmaceutical sector, foster mutual exchange, and co-create the 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, bringing a novel experience to the burgeoning biopharmaceutical industry in Chengdu and the broader Southwest region.
— Wang Xin
Chief Strategy Officer, BRC BIOTECHNOLOGY
Chengdu is a leading hub for the biopharmaceutical industry in western China, with its industrial landscape spanning multiple segments including biopharmaceuticals, chemical pharmaceuticals, and high-end medical devices. In particular, it has established a solid industrial foundation and a rich technological ecosystem in the research and development of innovative biologics, blood products, and vaccines.
As a provider of pharmaceutical filtration process solutions specializing in “membrane technology,” ALIOTH is honored to join colleagues from Chengdu’s biopharmaceutical enterprises at the “Biopharma Enterprise Tour” event. This gathering facilitates in-depth exchanges on the latest filtration technology products and solutions, as well as sharing interpretations of the most recent regulatory guidelines for filtration processes. We aim to support pharmaceutical companies in achieving domestic substitution and optimizing cost-effectiveness, thereby jointly promoting the development of new quality productive forces.
—— Jia Qijun
ALIOTH Founder & CEO
Highlights
Compliance:Assessments conducted in accordance with regulatory requirements, manufacturing processes, and product specifications constitute the core basis for drug quality.
Legal: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
■ 13:00-13:30 Event Registration
■ 13:30-13:35
Host's Opening Remarks
■ 13:35-14:05 Keynote Speech 1
AntibodyBLATesting Requirements and Regulatory Requirements by Stage
Batch Release of Commercial Antibody Products
Key Considerations for PSQ Testing of Commercialized Antibody Products
BRC BIOTECHNOLOGY
■ 14:05-14:35 Keynote SpeechLecture 2
Study on the Removal of HCP and HCD by Depth Filtration in Biopharmaceutical Purification
HCP and DNA Hazards in Pharmaceutical Manufacturing Processes and Regulatory Requirements
HCP and DNA Removal Strategies
Study on the Removal of HCP and DNA by Depth Filtration
ALIOTH
■ 14:35-15:05 Keynote Speech 3
High-Speed Detection Technology Empowers Production and Quality Control in Biopharmaceuticals
Revvity Biomedical
■ 15:05-15:25 Tea Break & Networking
■15:25-15:55 Keynote Speech 4
Key Points in Biosafety Testing of Antibody Drugs and Regulatory Differences Among China, the United States, and Europe
Compliant Application of Antibody Drugs
Integrated Solution for Biosafety Testing of Antibody Drugs
BRC BIOTECHNOLOGY
■15:55-16:25 Keynote Speech 5
Regulatory Development and Interpretation of Sterile Filtration Technology and Its Applications
Development and Overview of Sterile Filtration Regulations
Discussion on the Management Application and Practice Based on Regulations and Guidelines
Summary of Self-Inspection Points for Sterile Filtration Processes
ALIOTH
■ 16:25-16:55 Keynote Speech 6
High-throughput sequencingApplications in Quality Control of Biopharmaceuticals
Compliant Application and Regulatory Requirements of High-Throughput Sequencing Technology in Biosafety Testing
Discussion on Compliance Validation Strategies for High-Throughput Sequencing Technology and Technical Approaches for Exogenous Virus Detection
Bioinformatics Analysis Strategies and Quality System Compliance Issues in the Application of High-Throughput Sequencing Technology for the Detection and Identification of Exogenous Viral Contamination in Biological Products
BRC BIOTECHNOLOGY
■ 16:55-17:05 Summary, Lucky Draw & Group Photo
Oil Painting Bookmarks, Lucky Draw Blind Boxes, Waist Fans as Souvenirs—Waiting for You to Claim
Event Scale: 50 people/session
Event Registration:
Capillary 17782369627 (WeChat ID same)
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Send"Biopharma Enterprise Tour"Registration
About BRC BIOTECHNOLOGY
BRC BIOTECHNOLOGY specializes in compliance, quality, and safety testing services for biopharmaceuticals. The company has established a testing service platform, commercial office space, and training center spanning over 16,000 square meters across Shanghai and Suzhou, all compliant with cGMP, GLP, and BSL-2 standards. BRC BIOTECHNOLOGY strictly adheres to various national pharmacopoeias as well as domestic and international regulations, and has obtained EU GMP QP certification, an FDA FEI Number, ISO 9001:2015 certification, BSL-2 accreditation, and CMA qualification.CNAS...and other certifications, ensuring the authenticity, validity, and data integrity of test results. It aligns with international quality standards for biological drug evaluation systems, supporting quality assessments of biological products such as biologics, cell and gene therapies, nucleic acid drugs, and vaccines. Currently, BRC BIOTECHNOLOGY possesses comprehensive biosafety testing capabilities, including in vivo animal studies. Through integrated services and a strict no-subcontracting policy, our stable and controllable quality system covers all biosafety testing items and the entire product lifecycle. Adhering to the service philosophy of efficient delivery and scientific rigor, BRC BIOTECHNOLOGY has established proprietary biosafety testing capabilities, passed audits by nearly 100 leading domestic and international biopharmaceutical companies, and successfully submitted multiple IND and BLA applications in both China and the United States. As your partner in biosafety testing, we provide one-stop, high-quality biosafety testing services to accelerate the regulatory approval and market launch of innovative biopharmaceutical products.
Shanghai GMP Testing Center:
Provides GMP-grade biosafety testing. Its molecular, immunological, microbiological, viral, and cellular testing platforms, which comply with GMP and international quality standards, have successfully supported domestic and international IND/BLA filings for vaccines, mRNA, antibodies, and cell and gene therapy products.
Suzhou GLP Testing Center:
Provides GLP-compliant viral clearance validation services and CNAS-accredited animal testing services, supported by complementary laboratory platforms including electron microscopy. Has successfully supported nearly 100 domestic and international regulatory filing projects and has passed EU GMP/GLP Qualified Person (QP) audits.
BRC BIOTECHNOLOGY Provides You with
⸺ GMP ProductionCell Bank Establishmentand verification
⸺ Drug Substance and Product Testing Services
⸺ Development of Customized Product Testing Technologies
⸺ Viral Clearance Validation Services for Manufacturing Processes
⸺ Technical Consulting on Product Quality Compliance
About ALIOTH
Alioth Biotech (Shanghai) Co., Ltd. specializes in the development and application of filtration products and technologies for pharmaceutical manufacturing processes, and is committed to providing high-quality separation and purification solutions that comply with domestic and international regulatory requirements for pharmaceutical enterprises.
ALIOTH has established its own production bases in Shanghai Lingang and Hangzhou in accordance with GMP requirements. The company is equipped with process development laboratories, validation laboratories, and a filtration product R&D center, and has built an R&D team led by membrane technology scientists. These initiatives aim to better safeguard the supply chain security of Chinese pharmaceutical companies, assist users in optimizing drug R&D and production processes, and enhance the safety of pharmaceutical manufacturing.
Guided by its corporate values of creating value for customers, pursuing endless improvement, fostering collaborative evolution through teamwork, demonstrating proactive responsibility, and embracing change through continuous learning, ALIOTH empowers the innovative development of China’s pharmaceutical enterprises.
About VCBeat New Medicine
Artery New Medicine isVCBeatVCBeat’s media and research platform, focused on biomedicine, delivers “in-depth” and “incremental” communication value to innovators and entrepreneurs through both content and operations. In terms of content, it features exclusive financing announcements, corporate interviews, the “Drug Developers” column, in-depth industry analyses, and sector reports. On the operational front, its branded program “VB Think Tank” focuses on practical challenges, discusses industry trends, and fosters tangible collaborations through intellectual exchange.
Special Topic Achievements: [CGT】【IPO-Financial Report Analysis】【iPSC】【Nuclear Medicine Pharmaceuticals】【Protein Degraders】【Upstream Tools】【Synthetic Biology】【Organoids】【VB Insights Forum], etc.
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