News center
The global vaccine R&D market is growing rapidly, with Evaluate Pharma reporting a market size exceeding 100 billion USD in 2022, projected to surpass 150 billion USD by 2027 at a 7.2% CAGR. This growth is fueled by mRNA breakthroughs, alongside advancements in polyvalent, combination, and therapeutic vaccines. Meanwhile, emerging infectious diseases, stricter regulations, and shorter development cycles have heightened demands for vaccine bioanalysis.
Vaccine bioanalysis, as a vital part of vaccine development covering early research, clinical trials and post-market monitoring, requires accurate, reliable data and the ability to adapt swiftly to innovative vaccine technologies. Beijing Shouyan Lab of SDM has emerged as a leader in the business, leveraging strong technical expertise, an experienced team, and efficient services.
Dr. Shen Liping, Deputy General Manager of SDM and head of the vaccine analysis platform at Beijing Shouyan Lab, is a seasoned expert in the field of vaccine bioanalysis. With 25 years of industry experience, Dr. Shen, a former Principal Investigator, researcher, and graduate student supervisor at the Chinese CDC’s Institute for Viral Diseases, has long been engaged in vaccine immune efficacy evaluation, hepatitis virus serology, molecular epidemiological testing, viral culture, and isolation identification. Dr. Shen Led 6 national and provincial-level research projects, published over 60 papers, and received multiple provincial-level science and technology progress awards. Currently serves as an expert in the National Immunization Program Technical Working Group.
Recently, we interviewed Dr. Shen to share her insight in innovative practices and technological advancements in vaccine bioanalysis.
Dr. Liping Shen, Deputy General Manager of SDM Lab Business - Beijing Shouyan
Rapidly Addressing Industry Challenges to Meet Diverse Vaccine Testing Needs
Recent advancements in vaccine development have introduced innovative platforms like mRNA, DNA, and viral vector vaccines, alongside traditional inactivated and live attenuated vaccines. Applications of vaccines now extend beyond infectious disease, prevention to cancer treatment and chronic disease management. These novel vaccines, with distinct immunogenicity mechanisms, demand higher standards for bioanalytical testing.
“New vaccines vary in development technologies, ingredients, and immune response mechanisms, impacting required bioanalysis tests, including differences in cytokine types, detection methods, antigen targets, and humoral immune levels.”Dr. Shen explained“These variations require vaccine bioanalysis labs to quickly adapt to new technologies and develop validated testing methods.“
SDM Labs has successfully met these challenges with its agile response and technical expertise. For example, in a recent shingles mRNA vaccine project, the lab rapidly adjusted testing procedures and optimized its approach, delivering high-quality bioanalytical services to advance vaccine research.
Strong Technical and Service Capabilities for Precision Vaccine Development Support
The SDM Lab Vaccine Analysis Platform team excels in vaccine bioanalysis with robust technical expertise and service capabilities by building a comprehensive platform and gained extensive experience in testing vaccines like RSV, VZV, rabies, and influenza, effectively addressing experimental bottlenecks.
“Our goal is to deliver strong support for vaccine R&D and commercialization,” said Dr. Shen. “Whether traditional or innovative vaccines, Beijing Shouyan Lab ensures reliable and efficient analysis through technological innovation.” She highlighted the 23-valent pneumococcal vaccine as an example: “Its testing involves processing large sample volumes, which traditional methods handle slowly. By introducing automated enzyme immunoassay workstations, optimizing processes, and training our technical team, we’ve significantly boosted efficiency while maintaining data accuracy.”
Additionally, Dr. Shen led large-scale projects like the nationwide viral hepatitis seroepidemiological survey, laying a solid foundation for tackling emerging infectious diseases. “From managing testing teams and maintaining platforms to stabilizing data analysis methods, we’ve gained invaluable experience,” she said. “This expertise has been integrated into Shouyan Lab, enhancing our technical capabilities and efficiency. When new infectious diseases arise, we are well-prepared to respond swiftly and support vaccine development.”
Beijing Shouyuan Lab Staff Operating
Forward-Looking Strategy for Comprehensive Vaccine Development Support
Preparing for vaccine breakthroughs in the next 5-10 years, SDM Lab has invested heavily in technology, talent, and infrastructure.
Dr. Shen anticipates significant advancements in mRNA, multivalent, and combination vaccines, alongside innovations in traditional genetic engineering. “mRNA vaccines hold vast potential, but their unique immunogenicity mechanisms pose new testing challenges,” she explained. Highlighting the lab’s readiness, she added, “For mRNA vaccines, cellular immune testing requires analyzing diverse cytokines and peptide libraries. Our lab has completed method development and technical validation, enabling comprehensive bioanalytical support for new vaccine development and clinical trials.”
Additionally, the lab has made forward-looking investments in therapeutic and innovative vaccines. Dr. Shen noted the establishment of a pathogen nucleic acid testing platform, currently undergoing verification by the Chinese Academy of Inspection and Quarantine. “Moving forward, we will deepen our expertise in preventive vaccines while expanding services for therapeutic and innovative vaccines,” she explained. “For therapeutic vaccines, evaluating immunogenicity and pathogen clearance effectiveness requires advanced testing standards. Our lab is equipped with the necessary technical capabilities and team to meet these demands.”
Looking ahead, SDM Lab will remain customer-focused, driven by technological innovation, to deliver efficient and precise bioanalytical services to global vaccine developers. This will accelerate vaccine commercialization and advance global public health. As Dr. Shen stated, “We are not only supporters of vaccine development but also drivers of industry innovation.”
KY-0301 is the world's first nano-dual-anti-ADC developed by Novatim based on its own innovative nano-dual-anti-ADC platform “TPEBEN”.
Beijing Shouyan Lab is certified by NGSP in the United States.
Provide diverse and better treatment options for patients worldwide.
At the intersection of the end of the year, we sincerely invite you to join us in focusing on the shining points of the year, and to look back together and cherish the bright moments that have illuminated our way forward in the past year.
On October 24-25 2024, Dr. Yuwen, CBO and SVP of SDM Bioservices, was invited to attend the 2024 International Biomedical Industry Innovation Beijing Forum co-sponsored by DIA and Beijing Advanced Medical Equipment Industry Innovation Alliance. The forum brings together representatives of global regulators, leading experts in biomedicine, industry leaders and academics to discuss the latest trends and industry innovations in global drug development.
AMWC China 2024 World Congress on Aesthetics and Anti-Aging was successfully carried out in Chengdu on October 18-20, 2024, with medical and aesthetic experts, scholars, and industry practitioners from all over the world participating and presenting their latest achievements.
On July 24, SDM Bioserices and Australia JP Medical Consulting Pty Ltd (hereinafter referred to as "JP Medical Consulting") announced a strategic cooperation. The cooperation aims to make full use of the clinical resources and professional advantages of the two sides in the field of medicine in China and Australia, promote the internationalization of clinical trials and new drug research and development, and provide one-stop services for Chinese biopharmaceutical enterprises in Australian clinical trials.
August 1, China, Beijing, Liu Xueliang, deputy secretary of the District Party Committee and district governor, led a team to visit key enterprises of Daxing biomedical Industry Base to investigate the development and construction of pharmaceutical research and development service platform enterprises.
On the way to further explore and promote the professional development of medical clinical trials, SDM and Tonghua Dongbao jointly successfully held a nine-month "Diabetes Professional CRA Series course".
On July 11-12, 2024, MedDRA MSSO successfully held the fourth offline face-to-face training of 2024 at the Shenyang office of SDM. As the organizer of this event, SM gathered together with more than 40 experts from various fields such as CRO, pharmaceutical companies and partners, including medical coders, data management and statistics, drug safety/pharmacovigilance, medical writers and other modules.
On July 3, 2024, SDM Bioservices and Shanghai Ruiningkang Bio-Pharmaceutical Technology Development Co., LTD. (" Ruiningkang Bio ") reached a strategic cooperation to work together to help innovative drugs in the quantitative pharmacology, dose exploration level, and promote more innovative drugs with global competitiveness to the market.
On November 21, 2023, Beijing Kangle Guard Biotechnology Co., Ltd. is affiliated with Muhammadiyah University Malang, Indonesia (at) to start the "restructuring nine price 6/11/16/18/31/33/45/52/58) human papilloma virus (HPV) vaccine (e. coli) phase III clinical trials into the group of vaccination. As a CRO focused on vaccine clinical trials, Shanghai SDM undertook the phase III clinical study of the vaccine project in Indonesia, responsible for project management, data management, biostatistical analysis, pharmacovigilance and other important work of the project.
The laboratories operated by SDM in the North and South have their own specialties and technical advantages. Among them, Beijing Shouyan, with several P2 and P2+ laboratories and complete PCR testing facilities, is one of the few testing organizations in China focusing on bioanalysis of vaccines and traditional Chinese medicines; Hangzhou Amador focuses on XDC, macromolecules, and CGT, etc., and provides one-stop bioanalytical services for ADC drugs, which is a technological leader in the industry.
Meiji has advanced its oral paclitaxel softgel capsule, MJC-001, to clinical trial stage. With support from SDM Bioservices, Meiji received FDA clearance for its Investigational New Drug (IND) application, positioning it among the leading developers of oral paclitaxel formulations.
Listen to Dr. Liping Shen: Innovating Vaccine Bioanalysis for Change
KY-001 is an oral small-molecule inhibitor targeting the YAP/TAZ-TEAD interaction in the Hippo pathway with a proposed indication for advanced solid tumors driven by Hippo dysregulation.
Get in touch with SDM experts for your questions or comments and a member of our team will get back to you directly.
Let's Start a Conversation
