September 4, 2022, Seminar on How to Break Through the Barriers of Antibody Commercial Production hosted by Hualan Bio & ShengMing Bio and co-organized by their partners was successfully held in Hualan Biological Industrial Park, Plain Demonstration Area, Xinxiang City. We were fortunate to invite Mrs. Shibin, Director of SAPA-China to chair the conference, Mrs. Pan Ruowen, Executive Deputy General Manager of Hualan Biological Bacterin Inc. to give a welcome speech, and Mrs. An Wenqi (Member of the Board of Hualan Bio, General Manager of Shengming Bio), Mrs. Wanglan (Researcher of National Institutes for Food and Drug Control), Mr. Lin Jihan (R&D Director of Shanghai Tofflon Science and Technology Co., Ltd), Mr. Xiao Zhihua ( Chairman of the Board of Shanghai OPM Biosciences Co., Ltd ), Mr. Yang Shengjiao (Product Manager of Lisure Science (Suzhou) Co., Ltd ), Mr. Liu Xuping (CEO of Shanghai BioEngine Sci-Tech Co., Ltd), Mr. Tang Yifeng (Implementation Director of Baimosi (Chengdu) Digital Technology Co., Ltd) to conduct speech sharing. Next, Shengming Bio held the commencement ceremony of CMFII-30000L production line construction. Mrs. Anwenqi invited Mrs, Pan Ruowen, Mr. Liu qianjin (Deputy General Manager of Austar Group), Mr. Zheng Xiaoyou, Mr. Luoliang (Deputy General Manager of Lisure Science (Suzhou) Co., Ltd ), Mr. Lin Jun (General Manager of Chengdu Shenke Industrial Equipment Installation Co., Ltd ) as the guest representatives to witness the launching ceremony of CMFII-30000L Production Line of Shengming Bio. Then, all guests orderly visited the large-scale production line of the CMFII Project of Shengming Bio. The CMFII takes the cGMP of China, the USA, and European as standards, including two same and independent 35000L production lines with the reasonable layout of function areas, thus the production interaction is more flexible. Besides, 18 exhibitors made a stunning appearances, and many old and new friends stopped by to visit and discuss with industry peers in depth.We appreciated the partners who expressed strong support during the construction of the CMFI& CMFII production platform. We believe that this will play an important role in the commercialization cooperation of monoclonal antibodies. We sincerely thank all the co-organizers for their affirmation. We are looking forward to meeting you better!

Exhibition information that Shengming Bio plans to participate in for the year of 2022 is as follows:1.[Hangzhou] Biocon China Expo 2022Time: July 20-22, 2022Location: Hangzhou International Expo CenterBooth: D202.[Beijing] The 3rd Quality Science of Biologics Summit Time: August 12-13, 2022Venue: Crowne Plaza Beijing Chaoyang U-townBooth: A583.2022 China Biopharmaceutical Industry Conference (Xiamen)Time: October 6-9, 2022Venue: Xiamen Fliport C&E Center, Hall B (Xiamen Wutong Fliport Hotel)Booth: B3C314.[Zhuhai] CBioPC 2022Time: October 29-31, 2022Venue: Zhuhai International Convention & Exhibition Center (No. 1663, Yinwan Road, Xiangzhou District, Zhuhai City)Booth: TBD

Work Together for Win-win Cooperation----Conference for Antibody Commercial Production1.Purpose of the conferenceChina's antibody industry has developed explosively in recent years. With the approval of several biosimilar for marketing, China's antibody industry has experienced a period of technological accumulation and has entered the stage of commercial production. At the same time, with the continuous expansion of the scope of domestic centralized procurement and the strengthened competition of foreign primary antibodies, how to improve the output and reduce the cost of domestic antibody commercial production on the premise of ensuring the quality has become a prominent problem.The national "14th Five-Year Plan" for the development of the pharmaceutical industry emphasizes the importance of the upstream supply chain of medicine and repeatedly mentions the "stable and controllable supply chain", including equipment and equipment, culture medium development and industrialized production, industrial upstream and downstream consumables and starting packaging materials, and other subdivisions. From this, we can see that China's antibody drug industry is facing rare opportunities and great challenges!If you are still confused about how to increase production and reduce costs;If you are eager to visit the production line in person, compare the differences between imported reactors and domestic reactors, as well as domestic and foreign purification equipment, and further grasp the capabilities of domestic large reactors and domestic purification equipment;If you want to know the difference between Chinese and foreign industrialized culture media and the current market situation of industrial grade consumables;If you want to master the current development of China's CDMO market first;Then you must not miss this conference!2.Conference informationTime: according to the domestic epidemic situation, the meeting time is expected to be from July to August;Venue: Hualan Biologic Industrial Park, xinxiang Plain Demonstration Area, Henan ProvinceSponsor: Henan Shengming Biotechnology Research Institute Co., LtdCo-organizers (in no particular order):Shanghai Tofflon Science and Technology Co., LtdLisure Science (Suzhou) Co., LtdShanghai OPM Biosciences Co., LtdStrategic partners (in no particular order):Shanghai LePure Biotech Co., LtdHangzhou Cobetter Filter Equipment Co., LtdBestchrom (Shanghai) Biosciences Co., LtdChengdu Shenke Industrial Equipment Installation Co., LtdParticipation method: participating units and partners can publicize the meeting with official account and register in the form of appointment registration. The organizer will send an invitation letter after screening customers according to the registration.Henan Shengming Biotechnology Co., Ltd. (hereinafter referred to as Shengming Bio) is an emerging CDMO company. On the occasion of the completion of its 6 × 5000L antibody production line, users and suppliers in the industry are sincerely invited to discuss and visit the Shengming biological production site on "Seminar on How to Break Through the Barriers of Antibody Commercial Production", discuss the development of the biomedical industry, build a collaborative development mechanism, form a complete industrial ecosystem, and promote the high-quality development of the domestic antibody industry.3.Activity arrangementThe first day:15: 00-18:00 Registration place: Xinxiang Big Data Industrial Park18: 30-20:00 Dinner and accommodation: Xinxiang Big Data Industrial ParkThe second day:7: 50-8:30 Drive to Hualan Biologic Industrial Park8: 45-9:30 Guest speech: Guest chair: McAb Development under the New Situation9: 30-10:00 Shengming Bio: Monoclonal Antibody R & D and Industry10: 00-10:30 Tofflon Technology Topic10: 30-10:50 Lisure Technology Topic10: 50-11:10 OPM Biology Topic11: 10-12:10 visit Shengming Bio large-scale production line12: 10-13:00 Buffet lunch13: 00-15:00 Guests speak, subject to be determined

Recently, Lou Yangsheng, Secretary of the Henan Provincial Party Committee, and his delegation went to Hualan biological for investigation. Accompanied by Ankang, Chairman of Hualan Bio, Fan Bei, General Manager of Hualan Bio, and An wenqi, General Manager of Hualan Gene, Secretary Lou came to Hualan Bio Industrial Park to inspect product displays and understand product R & D, production and management, etc. Secretary Lou exhorted enterprises to strengthen talent team construction, constantly improve their independent innovation ability, and develop more new drugs and good drugs to serve the people's health.Secretary Lou encouraged enterprises to rely on rich innovation resources, continue to innovate systems and mechanisms, give full play to the advantages of scientific research talents and the main role of enterprise innovation, increase efforts to tackle key problems in "stranglehold" technology, critical common technology, iterative technology and other aspects, promote the coupling of industrial chain, innovation chain, supply chain, factor chain, policy chain, and improve the overall innovation and core competitiveness. An innovation ecosystem should be created to vigorously introduce and gather high-end talents, young talents and skilled talents, build a good platform, create an excellent environment, and strive to build an innovative enterprise.

Cell engineering is an important aspect of bioengineering. In general, it applies the theories and methods of cell biology and molecular biology to carry out genetic operation at the cell level and large-scale cell and tissue culture according to people's design blueprint. At present, the main technical fields involved in cell engineering include cell culture, cell fusion, cell disassembly, chromosome manipulation and gene transfer. Through cell engineering, useful biological products can be produced or valuable plants can be cultivated, and new species or strains can be produced.

Using analytical means to analyze products in all aspects from the perspective of physics and chemistry, whether it is to characterize reference products at different stages, evaluate different batches of products, or used for comparative research on biosimilar drugs or improved biological drugs, it will meet the requirements of scientific standards and international regulations.What we can do:Peptide level: amino acid sequence analysis, n/c-terminal sequence analysis, amino acid modification analysis, N-sugar site /o sugar site analysis, disulfide bond, peptide map / peptide spectrumProtein level: complete molecular weight, desaccharide molecular weightSubunit level: reducing molecular weight, desaccharide reducing molecular weightPreparation level (advanced structure): UV spectrum, fluorescence spectrum, Raman spectrum, DSF, circular dichroismPhysical and chemical properties: protein content (extinction coefficient study), amino acid composition analysis, glycosylated protein, sialic acid content, sugar type (n glycoside /o glycoside), free sulfhydryl content, size heterogeneity, charge heterogeneity

Through the in-depth connection of the entire industrial chain from pre clinical research, clinical trials to commercial product production, it provides innovative process research and development and production services for enterprises, and replaces pure capacity output with high value-added technology output.

Information collection and preliminary risk assessment: carry out scientific risk assessment according to the information of drug packaging materials, packaging specifications, physical and chemical properties, route of administration and daily large dosage provided by customers, and customize project specific research schemes for customers.It covers the extraction research of ionic strength, pH, polarity, etc., so as to obtain sufficient and complete extractable materials and help customers screen better direct packaging materials.Combined with the actual production and development process of customers, simulation experiments under extreme conditions are designed to simulate the extractable situation of actual drugs and packaging systems under poor conditions, so as to provide a scientific basis for the selection of migration research detection items and methods.According to the Chinese Pharmacopoeia, USP and other relevant regulations, the life cycle management of the test method is carried out. The methodological validation items include but are not limited to specificity, accuracy, precision (repeatability, intermediate precision), detection limit and quantitative limit.Safety evaluation: refer to the toxicological data provided by TOXNET, FDA, ICH, EMA, etc., and calculate the analysis and evaluation threshold (AET) according to PDE and SCT, so as to evaluate the safety of extractables and leachables content results.Research evidence: YBB 00142002-2015 Drug Packaging Materials and Pharmaceutical Compatibility Test Guidelines, Technical Guidelines on Compatibility Research between Chemical Drug Injection and Plastic Packaging Material (Trial), Technical Guidelines on Compatibility Research between Chemical Drug Injection and Pharmaceutical Glass Packaging Container(Trial), Technical Guidelines on Compatibility Research between Chemical Drugs and Elastomeric Sealants (Draft for Comments), USP<1663>, USP<1665>, USP<665>, and ICH Guidelines, etc.