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IBQC 2nd International Conference on Quality of Biological Drugs First Round Notice

 Last Update: 2022-09-14
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September 22-23, 2022 Suzhou, China

All related: September 22-23, 2022 Suzhou I, Conference Chairman II, Conference Speech III, Organizational Structure IV, Time and Place V, Conference Features VI, Participants VII, Conference Schedule (Subject to the Second Round Notice)

September 22	IBQC 2nd International Congress on Quality of Biological Drugs · Main venue
Time/Time	Presentation Report/Topic	Speaker/Speaker
09:00-09:08	Opening remarks	Huang Zhengming, President of china Medical Education Association
09:08-09:16	Speech at the Conference	Sun Xianze, Chairman of the Chinese Pharmaceutical Association
09:16-09:24	Speech at the Conference	Li Yunlong was former president of the China Institute of Food and Drug Control
09:24-09:34	Speech at the Conference	Shum Guoshan Vice President of the United States Pharmacopeia Commission (USP) and Head of China
09:34-10:00	In 2019, the World Health Organization (WHO) released the Implementation of the Global Benchmarking Tool (GBT) to assess the National Regulatory System for Pharmaceutical Products (NRA) globally, of which the Laboratory Access Section (LT) is one of them. How vaccine laboratories can build a quality management system (QMS) that meets the GBT assessment tool is a major challenge for the industry. This presentation focuses on lt, a laboratory section of the WHO-GBT assessment tool, and how to address the difficulties faced.	Xiang Xinhua , Deputy Director of Quality Control Center, China Institute of Food and Drug Control
10:00-10:30	Revision of Biological Products of Chinese Pharmacopoeia (pending)	Dr. Xiong Zhao, Department of Biological Products, National Pharmacopoeia Commission
10:30-11:00	Coffee break/Break
11:00-11:40	Laboratory accreditation and biological drug quality control laboratory management The complex structure and process of biological products, the diversity and frontier of biological products testing technology, put forward higher requirements for the laboratory's people, machines, materials, laws, rings and other aspects . CNAS's Guidelines for accreditation of testing and calibration laboratories and application notes in related testing fields provide a basis for the establishment and operation of a mature quality management system for biologics laboratories, which can ensure the fairness and consistency of laboratory testing activities.	Li Rui Vice President of Jiangsu Institute of Food and Drug Supervision and Inspection
11:40-12:10	Research and development, quality control and application strategies of quadrivalent influenza vaccine As a common respiratory disease, influenza has never been far away from us, and its threat to human health has long been seriously underestimated . This report will share the development, quality control and application strategies of quadrivalent influenza vaccines.	Li Xiuling, Director of Shanghai Institute of Biological Products, Vice Chairman of Vaccine Clinical Research Branch of China Vaccine Industry Association, Editor-in-Chief of International Journal of Biologics
12:10-13:20	Lunch/Lunch
13:30-14:10	Research strategies on the compatibility of biologics and pharmaceutical packaging materials The compatibility of pharmaceutical packaging materials and drugs has always been a hot topic, and with the global spread of the new crown pneumonia epidemic, the demand for vaccines and biological injections has surged, and this report will share the research strategies for the compatibility of biological agents with pharmaceutical packaging materials.	Dr. Zhao Xia, Deputy Director of the Institute of Pharmaceutical Excipients and Packaging Materials Verification, China Institute of Food and Drug Control
14:10-14:50	Regulatory Thinking about mRNA Vaccines The application of mRNA vaccines has played a crucial role in global public health and led to the accelerated development of related technologies and industries. New technologies also bring many challenges to drug regulation, and how to carry out regulatory scientific research in this context is a problem that needs to be explored in depth. This report reviews the development background of new crown vaccines from the aspects of progress of mRNA vaccines, early clinical trials, production technologies and inspection points, regulatory characteristics of development and production, and vaccine delivery systems, introduces the application and challenges of mRNA from research and development to commercialization life cycle, analyzes clinical research concerns, discusses the considerations related to large-scale production processes and regulatory inspections, reviews the supervision of the development and production of new crown vaccines in China, and discusses nano-formulations and advanced manufacturing technologies . Through this report, it has attracted more attention to mRNA vaccines and promoted deeper regulatory scientific research .	Dr. Cao Meng Deputy Director of innovation and regulatory science development department of Shanghai Drug Evaluation and Verification Center
14:50-15:10	United States Pharmacopeia (USP) Biologics Strategy and Update USP biologics strategy and update	Dr. Fouad Atouf, Vice President, Global Biologics, United States Pharmacopeia Commission (USP).
15:10-15:40	Coffee break/Break
15:40-16:10	FDA Biologic Drug Declaration and Inspection	Dr. Peter Qiu, Former Auditor, U. S. Food and Drug Administration (FDA).
16:10-17:00	Case sharing of post-market quality standard changes for biological products After the listing of biological products, it may involve various situations that require changes to the key consumables used in the test methods in the quality standards, the test principles of the methods used, the test frequency (involving the purpose of testing), the test items, etc. ; This speech provides ideas for the audience through the consideration of practical cases and the sharing of implementation points.	RenMin, Director of Pharmaceutical Quality at VISEN

September 9	IBQC 2nd International Congress on Quality of Biological Drugs · Cell Therapy Session
Time/Time	Presentation Report/Topic	Speaker/Speaker
09:00-09:40	Basic Considerations of Cytopharmacy (CMC) Information - Correlation between "Quality" and Pharmaceutical Information Introduce the quality characteristics of cell drugs, the concept of "large quality", and the importance of quality research and standardized quality evaluation systems; The essence and core challenges of pharmaceutical research related to cell drug registration research; Correlation of cytopharmacological information with cell quality; At this stage, the core issues and basic coping strategies of chinese cytopharmacy research are regulated.	Dr. Yuan Baozhu was former director of the Cell Resources and Preservation Center of the China Academy of Food and Drug Control
09:40-10:20	Establishment of a cell therapy product quality control system Cell therapy product is a "live" drug that incorporates advanced medical technology, with special complex biological characteristics and safety risks . The principle of action and metabolic mechanism of cell therapy products are significantly different from those of traditional drugs, and it is difficult to control them according to the previous drug quality control system. This speech focuses on how to establish a scientific cell therapy product quality control system according to the characteristics of cell therapy products .	Dr. Yang Xiaoguang Deputy Director of the Key Laboratory of Cell and Gene Drug Quality Control of the State Drug Administration
10:20-10:50	Coffee break/Break
10:50-11:20	Understand how the overall solution of nucleic acid detection can empower cell therapy drug analysis This report includes: the application of fluorescence quantitative PCR technology in CGT: accurate detection of host nucleic acid residues, pathogens, replication lentivirus and CAR gene copy number; Ultra-high sensitivity digital PCR technology is applied to CGT: ultra-sensitive host nucleic acid residue detection, standard quantification, AAV titer determination; The Gold Standard Capillary Gene Analyzer of Sequencing Technology is used in CGT: Cell Therapy GMP Production Environment Monitoring, Cell Line Identification and Cell Contamination Detection, nucleic acid sequence sequencing verification .	Dr. Shikun Zhao, Head of Technology Application, Thermo Fisher Scientific Division
11:20-12:00	Biosafety Considerations of Cell Therapy Products As a rapidly developing drug form in recent years, cell therapy has made major breakthroughs in different disease treatment fields and has become the most anticipated pharmaceutical product in the field of human health. As a highly technical compound drug form, regulatory regulations are also constantly updated and improved in the development of cell therapy drugs, and guide the compliance and safe administration of drugs. This topic summarizes the development of domestic and foreign regulations, and compares and analyzes the product quality requirements and changes of cell therapy products. For the cell therapy product quality control technology to sort out and interpret, combined with the development of technology to trigger the thinking of quality detection technology.	Dr. Xin Wang, Chief Strategy Officer, Brilliant Biotechnology (Shanghai) Co. , Ltd
12:00-13:20	Lunch/Lunch
13:30-14:00	Verification of disinfection effectiveness in clean areas In the management of clean areas for drugs and medical devices, the selection and use of disinfectants is an important means of microbial pollution control. With the establishment of the national professional professional inspector team and the introduction of relevant policies, the use of disinfectants and the verification of disinfection efficacy have increasingly become the focus of supervision. This topic mainly combines the relevant standards and regulations of clean area disinfectants in China, the United States and Europe, and the non-conformities found in the audit process in recent years, so as to explore how to verify the effectiveness of clean area disinfection in compliance.	Jie Qin, Head of Microbiology Laboratory Technology , WuXi AppTec China Medical Device Testing Center
14:00-14:40	Regulatory requirements for non-clinical research and development of cell therapy products Cell therapy products include a variety of innovative products such as stem cells and immune cells, with different sources, mechanisms of action and risk factors, and their preclinical research needs to be analyzed on a case-by-case basis for their specificity. This year, the research heat of cell products has not decreased, and its regulatory system and regulatory system have also been continuously improved, and with the approval of very many products for clinical or marketing, there are also very good cases worth learning. This presentation elaborates on the latest developments in the regulatory requirements for non-clinical research on cell therapy products at home and abroad.	Dr. Huo Yan Vice President of Drug Safety Evaluation Department kanglong chemical into Vice Chairman of the Drug Safety Evaluation Professional Committee of the Chinese Pharmacological Society Expert and GLP Inspector of the Drug Review Library of the State Drug Administration Former Director of the Toxicology Office of the Drug Safety Evaluation and Monitoring Center of the Chinese Academy of Inspection
14:40-15:20	Quality risk control of segmented production of biological products under the MAH system China's biological products enterprises are in a stage of rapid development, with the maturity of their industrial chain and the acceleration of internationalization, the demand for segmented production is becoming more and more urgent . In the context of the implementation of the MAH system and the increasingly stable level of quality management, it has become possible for China's biological products enterprises to participate in the international industrial division of labor and serve global patients. This speech aims to discuss this issue as a whole in combination with the international regulatory environment and China's practical experience. First of all, the overall analysis of the current situation and international application of segmented production in China is carried out . The potential quality management risks and control methods of segmented production are further explored . Finally, the experience of insulin production in China for many years is introduced, in order to have a certain reference effect on the industry.	Dr. Jianchen Xu Director of Quality Compliance and Inspection Department of Novo Nordisk Global Quality Department
15:20-15:40	Coffee break/Break
15:40-16:10	Visible particulate matter and visual detection Particulate matter is defined as "foreign, movable, undissolved particles that are not intentionally present in solution, rather than bubbles. " Visual inspection is a probabilistic process, and the specific probability of detection of visible particles observed for a given product will vary with the dosage form, particle characteristics (such as size, shape, color, and density), and container design. Compared to transparent solutions in transparent containers, certain products and packaging limit the ability to inspect visible particles. This presentation will introduce USP guidelines for visible particulate matter, visible particles in injections<790> and 1790 > for visual inspection of injections <.	Dr. Desmond Hunt Senior Chief Scientist, General Standards, Scientific Division, U. S. Pharmacopeia Commission
16:10-16:40	Introduction, evaluation and application specifications of microbiological examination methods for cell products Due to their special aseptic production processes, quality attributes and clinical needs, classical microbial methods have been unable to flexibly adapt to the quality control and release needs of such high-risk preparations, and microbial alternative methods must be used in small quantities and rapid microbial alternatives 。 This report will combine the General Provisions of the Chinese Pharmacopoeia 9201, the New General Provisions of the "Microbiological Examination of Cell Products", and the guidance of similar foreign technical guidelines, introduce examples of new methods, verify and evaluate examples, application precautions, and introduce the implementation specifications when cell therapy products adopt new microbial methods .	Li Gaoyu Institute of Biochemical Drugs and Biological Products, Shanghai Food and Drug Inspection and Research Institute
September 9	IBQC 2nd International Congress on Quality of Biological Drugs · Vaccine Products Session
Time/Time	Presentation Report/Topic	Speaker/Speaker
09:00-09:40	Risk-based vaccine production site inspection considerations Vaccines are preventive biological products for the prevention and control of the occurrence and epidemic of diseases for human immunization, and vaccines, as special drugs, have a complex production process and must be safe, effective and controllable . This presentation focuses on the technical requirements for vaccine production and considerations for on-site inspections .	Jin Yulan, President of Shanghai Pharmaceutical Quality Association, Expert of Shanghai Municipal Drug Administration, Former General Manager of The Institute of Biological Products Affiliated to China Biologics
09:40-10:20	Study of cyanide residues in polysaccharide conjugate vaccines Polysaccharide protein conjugate vaccines are a type of vaccine formed by chemically bonding immunocompetent polysaccharides to proteins. When polysaccharide antigens are covalently bound to protein carriers, immunogenicity is enhanced and immune memory responses can be produced . Common polysaccharide conjugate vaccines include meningococcal polysaccharide conjugate vaccine and Haemophilus influenzae type b conjugate vaccine . There are two common polysaccharide binding modes, one is the linker method and the other is the direct binding method . Polysaccharide conjugate vaccines have many advantages and application prospects, but the use of excessive amounts of cyanide in the polysaccharide binding process is a matter of concern to us. Although there are means of removing cyanide in the process, such as dialysis, we still need to confirm that the reagents used in the polysaccharide conjugate have been removed by means of detection, which is a requirement in the "Technical Guidelines for Quality Control and Clinical Research of Conjugate Vaccines" in the national "Technical Guidelines for Preclinical Research of Preventive Vaccines ". The traditional analytical methods of cyanide include chemical analysis, ion chromatography, spectrophotometry, and gas chromatography, all of which have the disadvantages of complex pretreatment and long operation time. Based on the continuous flow injection ampere method and the pretreatment method of ultrafiltration, a new residual cyanide detection method was established for the accurate determination of the content of residual cyanide in polysaccharide conjugate vaccines. The project is currently supported by the National Pharmacopoeia Commission.	Li Yan Director of The Institute of Biological Products Inspection of Sichuan Academy of Drug Inspection the Academic Leader of the Key Laboratory of Quality Control and Evaluation of Vaccines and Biological Products of the State Food and Drug Administration Director of the Key Laboratory of Quality Monitoring and Risk Assessment of Biological Products of the Sichuan Provincial Food and Drug Administration GMP Inspector of the State Drug Administration
10:20-10:50	Coffee break/Break
10:50-11:30	Vaccines and vaccine quality Vaccines are one of the important means of preventing mass infectious diseases in humans, and play an important role in blocking the spread of diseases, and this lecture briefly discusses the vaccine quality and quality assurance system from many aspects, in order to encourage you with your peers.	Zhang Shumin Former President of Liaoning Chengda Biological Co. , Ltd. Doctoral Supervisor of Chinese Academy of Medical Sciences and Shenyang Pharmaceutical University Expert of Drug Review and GMP Certification expert of World Health Organization Biologics Expert
11:30-12:00	Automated Endotoxin Detection Solution Analysis – Regulatory Trends, Cost Reduction and Efficiency Improvement, and Method Validation Bacterial Endotoxin Inspection (BET) is an important tool for drug safety checks and quality control. However, traditional detection methods still face some challenges due to their excessive reliance on manual operation. As a result, the horseshoe crab experiment has evolved from a gel method to a rapid quantitative method or even an automated solution, and the technology is constantly improving and iterating . This report will specifically describe how the automated approach to microdynamic bacterial endotoxin detection can help companies achieve data reliability, cost reduction and efficiency, and specific method implementation .	Chen Weijiang Charles River Zhanjiang Andus senior technical support expert
12:00-13:20	Lunch/Lunch
13:30-14:10	Biological products production verification of bacterial species preservation and quality verification In the field of biological drugs at home and abroad, cell and gene therapy, mRNA vaccines, recombinant DNA proteins and other emerging industries are developing rapidly, and microbial strains as raw materials or carriers for the production of biological drug products, their quality requirements and control are very important, including Escherichia coli, Pseudomonas pseudomonas, Saccharomyces cerevisiae, Pichia yeast, etc 。 This report will introduce the relevant regulatory standards and standards for the preservation and quality verification of strains for the production and verification of biological products in the United States Pharmacopoeia (USP) and the Chinese Pharmacopoeia (CHP), discuss new technologies and methods of microbial testing and key quality control points, share the development trend and solutions of biopharmaceutical microbial detection technology, and empower the high-quality development of biological drugs.	Dr. Yao Su, Director of China Industrial Microbial Culture Preservation and Management Center
14:10-14:50	Biological drug virus detection technology past, present and future Biological drugs extracted from biological materials or expressed by cells are inherently at risk of virus contamination, so the virus safety control of biological drugs is the part that needs special attention in the production process of biological drugs, and virus detection technology plays a specific key role in the safety control of viruses. This speech will comprehensively introduce the application and development trend of existing related virus detection technologies at home and abroad, and help biological drug developers and production enterprises better understand related virus detection technologies and use these technologies reasonably.	Wang Jingchang Executive Director of WuXi Biology Suzhou WuXi Detection Virus Clearance Research and Virus Detection Center
14:50-15:20	Coffee break/Break
15:20-16:00	Contamination Control Strategies (CCS) in the Production of Biological Products Is particularly important for quality assurance of biological products, which must be produced in strict compliance with established and validated production and control methods . A pollution control strategy (CCS) should be implemented throughout the facility to define all critical control points and assess the effectiveness of all controls (design, procedural, technical and organizational) and monitoring measures used to manage pollution-related risks. CCS should be actively updated and should promote continuous improvement of production and control methods .	Xiaoming Wang is an expert in microbial control and sterility assurance
16:00-16:40	Microbial identification in the monitoring of biological drug production contamination Microbial identification is the determination of a large group of microorganisms such as bacteria, yeast and mold by measuring and analyzing the characteristics of unknown microorganisms (including gene sequences) or determining the level of gene, species and strains. In the field of pharmaceutical microbial pollution control, traceability analysis of microbial pollution is carried out through microbial identification, and changes in microbial populations in the controlled environment are analyzed, so as to formulate effective measures to prevent and control microbial pollution. This presentation will focus on the regulations related to microbial identification in the biopharmaceutical industry, commonly used microbial identification techniques, and the application of microbial identification in combination with case studies of contaminated microbial flora in clean environments.	Dr. Fengkun Du, Director of Quality Control Department, WuXi Biotechnology Co. , Ltd
September 9	IBQC 2nd International Congress on Quality of Biological Drugs · Gene Therapy Session
Time/Time	Presentation Report/Topic	Speaker/Speaker
09:00-09:40	Research on quality control of gene therapy products This report introduces the relevant regulatory requirements of gene therapy products and their quality control, focusing on quality control technologies such as quality standards and verification methods for gene therapy products, preparation and calibration of reference materials, and establishment and verification of cell banks and bacterial poison seed banks.	Rao Chunming Deputy Secretary-General of China Biochemical Pharmaceutical Industry Association Chairman of the General Principles Committee of Biological Products of the National Pharmacopoeia Committee Member of the National New Drug Advisory Committee GMP Inspector of the State Drug Administration
09:40-10:20	With the rapid development of biomedical technology and clinical diagnosis and treatment technology, biological drugs are increasingly used in the clinical treatment of tumors, infections, metabolism and endocrine, as well as immunity, blood system and other diseases, and have shown an irreplaceable role . In particular, biological drug therapy can significantly improve the prognosis of tumor patients, but the incidence of adverse reactions is also high, especially cardiovascular toxicity induced by antineoplastic drugs. Cardiovascular toxicity can occur in some patients within days to months of receiving medication. The cardiovascular toxicity induced by biological drugs is generally reversible myocardial dysfunction, and damage such as myocardial tissue necrosis is rare, and the mechanism of cardiovascular toxicity is still not very clear . When performing antineoplastic therapy, an in-depth understanding of cardiovascular toxicity mechanisms is essential to effectively protect the heart and ensure efficacy. This paper reviews the cardiovascular toxicity induced by various biological drugs and its possible mechanisms, and hopes to provide a reference for the clinical prevention of cardiovascular toxicity induced by biological drugs.	Dr. Wang Jufeng, Senior Vice President of Kanglong Huacheng (Beijing) New Drug Technology Co. , Ltd. Former Director of the Institute of Food and Drug Safety Evaluation of China Academy of Food and Drug Control, Director of the National Drug Safety Evaluation and Monitoring Center , External Expert of the State Drug Administration, Expert of the Science and Technology Expert Database of the Ministry of Science and Technology of the People's Republic of China
10:20-10:50	Coffee break/Break
10:50-11:30	Quality Control of Cell and Gene Therapy Products under GMP Specification The speech will discuss the development trend and quality control of the industry under the GMP specification, the method points of AAV vector quality detection, and the differences in detection in Sino-US clinical declarations.	Dr. Wang Zhimin Is a quality expert in the quality control department of Yiming Cell Technology Co. , Ltd
11:30-12:00	Characterization and quality control scheme of gene therapy products With the human research on gene molecular mechanisms, gene editing research is becoming more and more in-depth, the research and development of gene therapy products is more mature, gene therapy products are gradually entering everyone's vision, and more companies are entering this track . At the same time, because this is an emerging field, many scientists are conducting research and exploration of characterization and quality control protocols. Based on our many years of experience in overall solution design in this industry, we will provide you with the characterization and quality control solutions of gene therapy products, hoping to bring you some new thinking .	Dr. Nan Yao Senior Market Development Manager, Danaher Life Sciences Marketing Department
12:00-13:20	Lunch/Lunch
13:30-14:10	Biological products refer to preparations that use microorganisms , cells, animals or human tissues and body fluids as starting raw materials, and are made by biological technology for the prevention, treatment and diagnosis of human diseases, such as vaccines, blood products, biological technology wood drugs, microecological preparations, immunomodulators, diagnostic products, etc . Due to the characteristics of biological products, the quality control of biological product stability is particularly important . This speech focuses on the key points of stability quality control of biological products and the drafting of the 2020 edition of the Chinese Pharmacopoeia "Guiding Principles for Stability Testing of Biological Products".	Liang Weiyang , head of the Biological Products Department of Guangdong Provincial Drug Inspection Institute, member of the State Pharmacopoeia Committee, national drug GMP inspector , director of the Key Laboratory of Quality Control of Blood Products of the State Food and Drug Administration, director of the Key Laboratory of Quality Control of Blood Products of the Guangdong Provincial Food and Drug Administration
14:10-14:50	Macromolecular drug product quality control and efficacy evaluation Macromolecular drugs produced in living cells are highly complex molecules produced through a multi-step process of production and purification, and the key mass properties of these molecules vary depending on the cellular environment or post-translational modifications that occur during production, and degradation occurs during storage. When the production process changes, the product will also have problems . In order to ensure the safety of the product to the patient, the effectiveness of the symptoms, and the quality control, it is very critical to apply new quality concepts and means to manage the whole life cycle from the source to the end product .	Dr. Shi Liming Vice President of Hangzhou Yian Jishi Biopharmaceutical Co. , Ltd
14:50-15:20	Coffee break/Break
15:20-16:00	Relevant regulations and guiding principles of cutting-edge therapeutic drugs In recent years, the country's policy support and supervision of cell therapy drugs have gradually become clear, as well as China's accumulation in cutting-edge therapeutic drug technology, and this field has entered a stage of rapid development. Cell therapy, gene therapy, regenerative medicine treatment, etc. are clearly listed as one of the key industries for national key development and urgent need of intellectual property support, which puts forward high requirements for regulatory policies and technical evaluation systems. This report will introduce the regulatory systems and related regulations and guidelines for frontier therapeutic drugs in various countries .	Dr. Shen Hong, Deputy Director of The Institute of Biological Products of Zhejiang Food and Drug Inspection and Research Institute, Zhejiang Province Biological Products Development Site Inspector , Zhejiang Province Biological Products GMP Inspector
16:00-16:40	Liposome drug bioassay method strategy and case study Liposome is a new type of drug-carrying preparation, its pharmacokinetic behavior is complex, the relevant quality assessment standards are not perfect, and the corresponding technical guidance is lacking in China 。 Taking the dual-drug liposome daunorubicin-cytarabine studied by our center as an example, introducing how to establish the in vivo multi-component analysis method of liposome drugs will help solve the in vivo analysis difficulties of most of the liposomes currently under study and the accurate quantitative analysis of multiple components of the liposome drug delivery system in vivo, and accumulate experience and technical reserves for the development and review and approval of domestic liposome drugs.	Xu Xinxin Biological Sample Testing Center of Sichuan Institute of Drug Inspection and Research
September 9	IBQC 2nd International Congress on Quality of Biological Drugs · Antibody drug session
Time/Time	Presentation Report/Topic	Speaker/Speaker
09:00-09:40	Research progress in antibody drug quality control In recent years, the global antibody drug has developed rapidly, the variety of domestic antibodies has continued to increase, and the new antibodies represented by antibody conjugated drugs (ADCs) and bispecific antibodies have become hot spots in research and development, and the quality control technology of antibody drugs has continued to develop . This report will introduce the new technologies and methods of quality control research of antibody drugs from the aspects of key quality attributes of antibody drugs, such as structural characterization, heterogeneity, and biological activity, as well as practical applications and case sharing in product quality control.	Shao Hong, Director of Institute of Biochemical Drugs and Biological Products, Shanghai Food and Drug Inspection and Research Institute, Director of Shanghai Biotechnology Drug Quality Testing and Evaluation Professional and Technical Service Platform, Standing Committee Member of Supply Chain Branch of China Vaccine Industry Association
09:40-10:20	Application of U. S. Pharmacopeia Monoclonal Antibody Analysis Standards in Antibody Drug Quality Control Antibody drugs are the most successful biological products in recent decades, and as of 2022, more than 100 antibody drugs have been approved for marketing worldwide. However, how to ensure the safety and effectiveness of monoclonal antibody drugs through effective quality control strategies and control standards remains a challenge for global drug regulatory and standard-setting agencies. The United States Pharmacopeia includes a number of related technical standards and guidelines, including the analysis process of general principles<129> recombinant therapeutic monoclonal antibodies, including the physicochemical properties of antibodies, glycosylation modifications, activity analysis, purity and impurities, providing a basis for the establishment of industry standard methods. In addition, the U. S. Pharmacopeia has also launched a number of monoclonal IgG1 reference standards based on drug processes, supporting manufacturers to unify standards in multiple quality tests such as monoclonal impurity and purity analysis, glycosylation modification, and post-translational modification .	Dr. Tie Zou United States Pharmacopeia Commission (USP) China Headquarters
10:20-10:50	Coffee break/Break
10:50-11:20	Study and analysis of the applicability of host DNA/protein residue detection methods in biological products Various types of biological products can be used to prevent and treat diseases, which is related to the drug safety of patients and healthy people. Products such as recombinant protein drugs, antibody drugs, vaccines, cell and gene drugs in biological products are produced using continuously passed strains/cell line expressions. Although it has undergone a strict purification process, there is still a possibility of residual nucleic acids/proteins of host cells in the product, and from the perspective of biological product safety and effectiveness needs, various types of residues are the top priority of various quality control standards.	Dr. Wenjun Chen, R&D Director of Ecosay Biotech, Ph. D. , Fudan University, Shanghai/ Postdoctoral Fellow, Rutgers University
11:20-12:00	Biological activity/titer determination of biological products Focus and countermeasures Discussion Biological activity/titer determination is the key quality attribute of vaccines, antibodies and other biological drug effectiveness control, the measurement methods are mostly immunochemical methods, cell methods, animal methods, complex experimental operations, long experimental cycles, high personnel experience requirements, and many sources of variation, therefore, it is necessary to establish reliable and verified measurement methods to effectively control influencing factors . This report proposes the idea of optimizing the measurement method by eliminating the cross-reaction interference of different B-type antigens of the quadrivalent influenza virus vaccine and improving its measurement accuracy. At the same time, combined with the application of enzyme-linked immunoassay and reporter gene method in bioactivity assays, the focus of attention is proposed.	Dr. Lu Yihong Director of Biotechnology Drug Inspection Office of Jiangsu Academy of Food and Drug Supervision and Inspection Member of the Biochemical Drugs Committee of the National Pharmacopoeia Committee Member of the Safety Pharmacology Committee of the Chinese Pharmacological Society
12:00-13:20	Lunch/Lunch
13:30-14:00	Quality Control of Antibody Drugs Wisely and Efficiently Following the biopharmaceutical industry's widely accepted philosophy of quality by design (QbD), smart quality control stems from an understanding of the entire product lifecycle. Antibody drugs not only follow the aseptic guarantee concept of traditional chemical drugs, but also have many differentiated characteristics at key nodes because of the special preparation process. Effectively identify the key nodes, break through the traditional quality control ideas, and make efficient quality decisions in a more timely manner. The presentation will give examples and analyze several aspects of antibody drug quality control: the influence of microorganisms on continuous fermentation processes, the discovery and identification of bacterial endotoxins, etc .	Siyang Zhao Assistant Manager of Scientific Research Affairs, Mérieux's Industrial Microbiology Department
14:00-14:40	Monoclonal antibody drug identification research based on Raman spectroscopy and artificial neural network Raman spectroscopy has the advantages of fast detection speed and no sample pretreatment, and has been used in the identification of chemicals and dangerous chemicals . In order to meet the needs of sampling initial tests or other rapid identification tests of monoclonal antibody drugs, our institute intends to develop a monoclonal antibody drug identification method based on Raman spectroscopy. In the study, it was found that the existing map matching algorithm was not suitable for the establishment of a monoclonal antibody drug recognition model with high map similarity, so an algorithm using a long-term short-term memory neural network to extract map features and then achieve map recognition through comparison was proposed. Subsequently, by further studying the robustness and recognition ability of the algorithm, it is confirmed that this method has excellent monoclonal antibody drug recognition effect and good application prospects .	Dr. Ling Jin Institute of Biochemical Drugs and Biological Products, Shanghai Institute of Food and Drug Inspection and Research
14:40-15:20	Coffee break/Break
15:20-16:00	Antibody Drug Conjugates (ADCs) are antibody drugs that have emerged in recent years and have broad prospects for many indications, especially anti-tumor applications 。 This speech takes the new ADC molecule as the research object, for the key quality attributes of such drugs, the use of modern analytical technology to establish the target product and its related impurities analysis methods, in order to achieve in-depth research on the key quality of these antibody drugs, thereby obtaining effective technical support for the development of such innovative drug production processes and limited monitoring of process-related impurities, so as to finally establish a safe and effective control of the quality of the target candidate products.	Chen Weibin, Executive Deputy General Manager of Shanghai Gloria Ying Biotechnology Company
16:00-16:40	Antibody drug biology activity analysis and host cell protein residue research This lecture focuses on the development and establishment of antibody drug activity analysis methods, the application of characterization research and the study of host cell protein residue.	Dr. Rui Hu Senior Manager, Bioanalytical Development Department, Active Analysis

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of the 2nd International Conference on Quality of Biological Drugs IBQC August 22, 2022

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