Guest Lineup Announced for 'Safeguarding Biopharmaceutical Quality and Safety' Event in Yantai
BRC BIOTECHNOLOGY
Biosafety Testing Service Provider
ALIOTH
Process Support Technology Product Developer
Safeguarding the Quality and Safety of Biological Products
Antibody Drug Companies Tour
Organizer：BRC BIOTECHNOLOGY, ALIOTH
Organizer：VCBeat Pharma
Supporting Organizations：Shandong International Biotech Park
Event Time:May 31, 2024 (Friday) 13:30
ActivitiesLocation:Shandong International Biotech Park, Yantai, Shandong Province
The quality of biopharmaceuticals has always been a crucial guarantee for maintaining health and safety. While strictly adhering to regulatory requirements,MaximumPotential improvements in production efficiency and the adoption of advanced technological means for quality testing benefit both the biopharmaceutical industry and regulatory bodies. In the new era of pharmaceutical economics, the trend toward localization has caught up significantly. We remain rooted in China while keeping a global perspective. BRC BIOTECHNOLOGY’s biosafety testing services, together with ALIOTH’s filtration solutions, bring you a renewed 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 Drugs"] Antibody Drug Enterprise Tour will be held on May 31 (Friday) in Yantai.Shandong International Biotechnology Parkheld.
Shandong International Biotechnology Park — Actual View
# Highlights
Compliance:Assessments conducted in accordance with regulatory requirements, manufacturing processes, and product specifications constitute 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
■ 13:00-13:30 Registration
■ 13:30-13:35 Opening Remarks by the Host
Moderator | Event Expectations and Collaborative Support
■ 13:35-14:05 Keynote Speech 1
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
Yu Lingju | Technical Application Manager, ALIOTH
■ 14:05-14:35 Keynote Speech 2
Testing Requirements and Regulatory Requirements for Antibodies in the BLA Stage
Batch Release of Commercial Antibody Products
Key Considerations for PSQ Testing of Commercialized Antibody Products
Hu Xiao | Director of Operations, BRC BIOTECHNOLOGY
■ 14:35-15:05 Antibody Pharmaceutical Companies Topic
Analysis of Key Points in Cleaning, Disinfection, and Contamination Control Strategies for Clean Areas
Zhang Zhanghong | Technical Director, Hageya Biotechnology
■ 15:05-15:25 Tea Break & Riddle Interaction
■15:25-15:55 ChiefTopic AnalysisLecture 3
Regulatory Developments and Interpretation of Sterile Filtration Technology and Its Applications
Regulatory Development and Overview of Sterilizing Filtration
Discussion on the Management Application and Practice Based on Regulations and Guidelines
Summary of Self-Inspection Points for Sterile Filtration Processes
Liu Qiulin | ALIOTH
Regulatory Consultants and Filter ProductsHead of Development
■15:55-16:25 Keynote Speech 4
Key Points in Biosafety Testing of Antibody Drugs and Regulatory Differences Between China and Foreign Countries
Compliant Application of Antibody Drugs
Integrated Solution for Biosafety Testing of Antibody Drugs
Wang Xin | BRC BIOTECHNOLOGY Chief Strategy Officer (CSO)
■ 16:25-16:55 Keynote Speech 5
Testing Protocol for Rodent Cell Lines
Zhao Shikun | Senior Technical Manager, BRC BIOTECHNOLOGY
■ 16:55-17:05 Host’s Summary + Lucky Draw + Group Photo
Guest Introduction
Yu Lingju
ALIOTH Application Technology Manager
Yu Lingju graduated from Shanghai Polytechnic University with a major in Environmental Engineering. She currently serves as the Technology Application Manager at Alioth. Her primary responsibilities include process development, product selection, and related application support for the full portfolio of filtration, purification, and separation products across China’s pharmaceutical industry. With over 10 years of experience in the biopharmaceutical sector, she has previously held positions at renowned CDMO companies and within the technical department at Pall Corporation. She possesses extensive expertise in the development, optimization, and scale-up of downstream purification processes for antibody-based therapeutics.
Hu Xiao
BRC BIOTECHNOLOGY Operations Director
Xiao Hu, Ph.D. in Biology from the University of Bath, UK. Possesses over five years of experience in process development and cGMP manufacturing for antibody and cell therapy products. During his tenure at BRC BIOTECHNOLOGY, he led the management and operational compliance of the company’s cellular virology platform with US and EU regulatory requirements, supporting biosafety testing of antibodies, cell and gene therapies, and nucleic acid-based drugs for regulatory submissions in China and abroad.
Zhang Zhanghong
Hajueya Biotechnology, Technical Director
Zhang Zhanghong has 20 years of relevant experience in the pharmaceutical industry. He graduated with a major in microbiology and has engaged in microbiological testing, laboratory management, validation and qualification, quality assurance, and quality system establishment. He specializes in the construction of microbiological laboratory management systems and possesses extensive theoretical knowledge and practical experience in microbiological testing, method development and validation, clean area environmental control, disinfection and sterilization, microbial identification, and contamination investigation. He is well-versed in domestic and international GMP and related regulatory requirements, and is familiar with the production quality management of sterile preparations, oral solid dosage forms, and active pharmaceutical ingredients (APIs). He has successfully undergone multiple certifications under the 2010 edition of China GMP, FDA, EU GMP, TGA, and WHO standards. Consulting projects include BeiGene, Innovent Biologics, Junshi Biosciences, Henlius, RemeGen, Changchun GeneScience Pharmaceuticals, Akeso, Kanghong Pharmaceutical, Yontai Biotechnology, Zhejiang Medicine, Jingxin Pharmaceutical, Xianju Pharmaceutical, Qingfeng Pharmaceutical, Kunming Pharmaceutical, Kunming Jida, Ascletis Pharma, and Kintor Pharmaceutical, among other pharmaceutical enterprises.
Liu Qiulin
ALIOTH
Regulatory Advisor and Head of Filter Product Development
Liu Qiulin has worked at Merck for over 10 years, serving as Head of the BioReliance China Validation Services Laboratory, Senior Regulatory Consultant, Senior Marketing Technical Manager for Single-Use Products, and in technical consulting roles. She was primarily responsible for validation and regulatory affairs related to biosafety, including sterile filtration, single-use systems, viral clearance, and raw material safety, and has participated in numerous training sessions organized by the China National Medical Products Administration (NMPA). She contributed to the drafting of regulatory and technical documents such as the "Technical Guide for Sterile Filtration and Its Applications," "Key Points for Risk Control of Viral Contamination in Therapeutic Biological Products," and "International Technical Guide for the Application of Single-Use Systems in Pharmaceutical Manufacturing." She holds a Master’s degree in Microbiology from Shanghai Jiao Tong University.
Wang Xin
BRC BIOTECHNOLOGY Chief Strategy Officer (CSO)
Wang Xin, Ph.D. in Bioengineering. With 15 years of experience in managing biopharmaceutical process technology, he established a technical platform for biopharmaceutical processes and biosafety compliance in the Asia-Pacific region, supported the regulatory submissions of multiple cell and gene therapy products, and possesses comprehensive technical expertise in regulatory compliance. He leads the R&D and technical teams at BRC BIOTECHNOLOGY, having completed the development of over 200 assay technologies and provided regulatory compliance support for biopharmaceutical testing technologies.
Zhao Shikun
BRC BIOTECHNOLOGY Senior Technical Manager
Shikun Zhao, Senior Technical Manager at BRC BIOTECHNOLOGY, is responsible for client-side support of testing technologies and leverages his technical expertise to strengthen the theoretical foundation of the molecular technology platform. He holds a Ph.D. in Biological Sciences from Shanghai Jiao Tong University and pursued an MBA at the Antai College of Economics and Management, Shanghai Jiao Tong University. With many years of experience in molecular biology technical support and application support at Thermo Fisher Scientific, he has led teams in completing multiple collaborative customer projects, including sequencing analysis for SARS-CoV-2.
*The above speakers are listed in agenda order, not in any particular order.
Event Scale: 50 people/session
Event Registration:Capillary 17782369627 (WeChat ID same as phone number)
Engage in on-site interactions for a chance to win surprise gifts such as over-ear headphones, cultural and creative fridge magnets, and handheld summer fans!
About BRC BIOTECHNOLOGY
BRC BIOTECHNOLOGY specializes in compliance, quality, and safety testing services for biological drugs. The company has established a testing service platform, commercial office spaces, and training centers spanning over 16,000 square meters across Shanghai and Suzhou, all compliant with cGMP and BSL-2 standards. Strictly adhering to various national pharmacopoeias and domestic and international regulations, BRC BIOTECHNOLOGY has obtained certifications and qualifications including EU GMP Qualified Person (QP) status, FDA FEI Number, ISO 9001:2015, BSL-2, and CMA. These credentials ensure the authenticity, validity, and data integrity of test results. Its biological drug evaluation system, which meets international quality standards, supports quality assessments for biologics, cell and gene therapies, nucleic acid drugs, vaccines, and other biological products. Upholding a service philosophy of efficient delivery and scientific rigor, BRC BIOTECHNOLOGY has developed proprietary biosafety testing capabilities, passed audits by nearly one hundred leading domestic and international biopharmaceutical companies, and successfully supported multiple IND and BLA submissions. As your partner in biosafety testing dedicated to your success, we provide customers with high-quality, one-stop biosafety testing services to accelerate the regulatory approval and market launch of innovative biopharmaceutical products.
BRC BIOTECHNOLOGY Provides You with
GMP-Compliant Cell Bank Establishment and Testing
Drug Substance and Product Testing Services
Development of Customized Product Testing Technologies
Viral Clearance Validation Services for Manufacturing Processes
Technical Consultation on Product Quality Compliance
About ALIOTH
Alioth Biotech (Shanghai) Co., Ltd. specializes in the development and application of process-supporting technologies for pharmaceutical manufacturing, and is committed to providing high-quality separation and purification solutions that comply with domestic and international regulatory requirements for pharmaceutical companies.
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 for Chinese pharmaceutical companies, assist users in optimizing drug R&D and manufacturing processes, and enhance the safety of pharmaceutical production.
ALIOTH upholds its corporate values of creating value for customers, pursuing endless improvement, fostering collaborative evolution through teamwork, taking proactive responsibility, and embracing change with continuous learning, to empower the innovative development of Chinese pharmaceutical enterprises.
About Shandong International Biotech Park
Shandong International Biotechnology Park was established in 2010 and jointly invested in and constructed by the Administrative Committee of Yantai High-tech Zone and Luye Life Sciences Group, adopting a model of “government-enterprise cooperation, corporate-style management, and market-oriented operations.” It is dedicated to R&D innovation, public services, new technology incubation, enterprise cultivation, and achievement transformation in fields such as biopharmaceuticals, healthcare, regenerative medicine, and precision medicine.
The Yantai Pharmaceutical and Health Public Technology Service Platform, jointly established by the Yantai Municipal People’s Government and the Shandong International Biotechnology Park, is a core component of the park’s public service system. It features a “Ten Centers, One Base” structure covering the entire pharmaceutical and health industry chain, providing a vital platform for technological R&D and industrialization in the sector.
The park has currently attracted over 100 small, medium, and micro innovative startups, and is home to major enterprises, institutions, and hospitals such as the Yantai Branch of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences; the R&D Center of Luye Pharma Group; the Yantai Food and Drug Inspection and Testing Center; the China-Russia Science and Technology Innovation Park; the Yantai High-Level Talent Entrepreneurship Park; and Luye Medical Group. It has been honored with titles including “National Shandong Innovative Drug Yantai Incubation Base,” “Yantai Base of the National Comprehensive New Drug R&D Technology Platform,” and “National-Level Science and Technology Enterprise Incubator.”
About Hajueya Biotech
Hajueya Biotech is a professional disinfectant supplier, with the vision of becoming the most specialized provider of one-stop solutions for microbial control in the pharmaceutical industry. By empowering the pharmaceutical sector with professional technical services, it enables more compliant, efficient, and cost-effective control of microbial contamination.
About VCBeat New Medicine
VBMedi is a media and research platform under VCBeat, focusing on the biopharmaceutical sector. It provides “in-depth” and “incremental” communication value to innovators and entrepreneurs through two dimensions: content and operations. In terms of content, it primarily features exclusive financing announcements, corporate interviews, the “Drug Developers” column, in-depth industry analyses, and sector reports. On the operational front, its branded series “VB Think Tank” focuses on practical challenges, discusses industrial trends, and fosters tangible collaborations through intellectual exchange.
Thematic Achievements: [CGT】【IPO-Financial Report Analysis】【iPSC】【Nuclear Medicine】【Protein Degraders】【Upstream Tools】【Synthetic Biology】【Organoids】【VB Think Tank] etc.