Europharm, Hycells Biotechnology, and Beike Pharmaceutical Have Entered into a Strategic Partnership in the Field of RCL Testing
Release Date:
2024-07-09 14:23
NEWS
July 2024, Europharm Pharmaceutical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Europharm”) and Shanghai Hycells Biotechnology Co., Ltd. (hereinafter referred to as “Hycells Biology”), Beike (Beijing) Pharmaceutical Research Institute Co., Ltd. (hereinafter referred to as “Beike Pharmaceutical”) has entered into a strategic cooperation agreement, Jointly announced that CGT products include replicating-competent lentivirus (RCL) testing, mycobacterial verification, and other related areas. P3 Laboratory Engage in in-depth strategic cooperation in areas such as biosafety testing and research on the immunogenicity of peptide products. The three parties will fully leverage their respective strengths and expertise in the biopharmaceutical testing field to jointly provide end-to-end services to biopharmaceutical clients, thereby achieving mutual benefit and win-win outcomes.
Zhang Ang, General Manager of Europharm:
Although Eurofins BPT (Biopharma Product Testing) boasts a robust global GMP/GLP testing service network, certain capabilities cannot be fully replicated domestically due to its status as a foreign-invested enterprise and compliance with customs requirements. Hycells Biology is a rapidly growing provider of biopharmaceutical solutions, boasting extensive technical expertise and experience, as well as unique competitive advantages across multiple domains. For instance, Hycells Biotechnology has impressively demonstrated its capability in RCL testing using non-attenuated HIV as a control in Biosafety Level 3 (P3) laboratories, coupled with an internationally standardized quality management system—making it a rare P3 laboratory that has successfully undergone audits by overseas regulatory authorities. Furthermore, Eurofins, Hycells Biotechnology, and Beike Pharmaceuticals exhibit strong business complementarity. We are delighted to partner strategically with such an enterprise on the path of mutual development. By leveraging each party’s core strengths, we aim to achieve complementary advantages and deliver mutual empowerment, thereby contributing to the quality and safety of China’s biopharmaceutical industry.
Zhou Bin, General Manager of Hycells:
Hycells Bio is a company dedicated to the development of innovative services and products in the CGT field. Leveraging its established platform and extensive experience, it addresses the key pain points and challenges faced by clients during drug development, thereby empowering innovative pharmaceutical companies to achieve high-quality growth. Since commencing operations at its China laboratory in 2022, Europharm has demonstrated remarkable growth, injecting stronger capabilities into the domestic biopharmaceutical safety-testing sector. Beike Pharmaceuticals boasts an abundant collection of microbial and viral strains as well as a highly skilled technical team, providing a robust technology-service platform for biosafety testing, vaccine evaluation, and drug discovery. We look forward to long-term, in-depth collaboration among the three parties, whereby each will mutually empower and enhance its competitive edge in safety testing for cell and gene therapy products, ultimately delivering end-to-end biosafety-testing services tailored to innovative pharmaceutical companies.
Zhao Yue, General Manager of Beike Pharmaceuticals:
As a service provider with core strengths and innovative capabilities in the microbiology and virology fields, Beike Pharmaceuticals has established a comprehensive, stable, and reliable service system spanning biosafety, vaccines, and anti-infective therapeutics. This collaboration with Europharm and Hycells Bio to jointly develop a globally competitive RCL project marks the foundation and starting point for all parties to build long-term, complementary advantages and further leverage pipeline synergies, while also representing a significant milestone in jointly unlocking the global service potential of this flagship program. We place great importance on this partnership and look forward to leveraging it to empower each other and accelerate the overall development of the industry.
Gene therapy and cell therapy have become hotspots in drug research and development both domestically and internationally. According to the U.S. FDA, cell therapy products encompass cellular immunotherapies, cancer vaccines, and various types of autologous and allogeneic cells used for the treatment of specific conditions. The Chinese NMPA defines cell therapy as a therapeutic approach that involves the use of human autologous, allogeneic, or xenogeneic somatic cells, which are manipulated ex vivo and then reinfused (or implanted) into the patient. In contrast, the European Medicines Agency (EMA) classifies cell therapies—such as CAR-T products—as gene therapy products, given that their mechanism of action relies on genetic modification of cells to achieve therapeutic effects.
For cell therapy products such as CAR-T, lentiviral vectors are typically used for cellular genetic modification. Lentiviral vectors are derived from human immunodeficiency virus type 1 ( human immunodeficiency virus , HIV-1) is a gene therapy vector developed on this basis. Lentiviruses are derived from retroviruses but differ from them in that they exhibit even stronger infectivity and elicit only minimal immune responses.
Most retroviruses and lentiviruses used in gene therapy are engineered as replication-deficient viral vectors. Consequently, for immune-cell–based therapeutic products that employ viral vectors for genetic manipulation, the emergence of recombination-derived replication-competent lentiviruses (RCL) represents a major safety risk. RCLs pose a potential pathogenic risk to humans. Therefore, regulatory authorities worldwide recommend that this issue be thoroughly addressed not only during product design and quality studies but also through long-term post‑marketing surveillance, in order to eliminate the risk of RCLs in human cell‑therapy products based on lentiviral vectors.
Replication-competent viruses are associated with product safety and require reference to relevant research experience or literature to develop and establish sensitive detection methods. Commonly used methods include indicator cell culture assays and direct qPCR. Test samples include virus preparations harvested during the production of replication-competent lentiviral vectors (RCL) for detection; based on the current state of research, it is recommended to use indicator cell culture assays for RCL testing of lentiviral vectors. For HIV-derived lentiviral vectors, the positive control used for RCL detection may be an HIV strain that meets the assay requirements—for example, a strain lacking accessory genes—prepared using the same manufacturing process and handled and used appropriately under compliant conditions. Regarding RCL detection parameters, p24 protein is generally considered to be Reverse transcriptase The detection of activity, psi-gag, and VSV-G sequences, among others, can indicate the presence of RCL; appropriate assay parameters should be selected based on the specific characteristics of the viral vector and the research context.
The vaccine and infectious disease drug R&D and evaluation technology platform jointly established by Hycells Biotechnology and Beike Pharmaceuticals is equipped with BSL-3 and ABSL-3 biosafety laboratory accreditation, providing an inherent platform advantage for RCL testing. This platform is suitable for handling agents that pose a high risk to humans, animals, plants, or the environment through direct contact or Aerosol Viruses that can cause severe, even fatal, illnesses, such as SARS, H7N9, and MERS. Meanwhile, Europharm’s global laboratory network has amassed extensive experience and robust capabilities in RCL testing, further bolstered by a team of domestic technical experts. It is our hope that Europharm, in collaboration with Hycells Biotechnology and Beike Pharmaceutical, will jointly deliver high-quality, fast-turnaround analytical testing services to clients, thereby supporting their pharmaceutical quality research efforts.
The team at Shanghai Hycells Biotechnology Co., Ltd. has been deeply engaged in the field of cell therapy for many years, continuously refining its quality management system and upgrading and optimizing its technology service platform. Upholding a corporate culture and attitude characterized by innovation, openness, and inclusiveness, the team remains committed to addressing clinical needs and industry pain points through continuous product and service innovation, delivering truly valuable, differentiated offerings to its clients. With the collective support of all stakeholders, the company aims to strengthen its pipeline of R&D products and services, further empower its partners across the ecosystem, and jointly advance the development of the cell therapy sector.
About Europharm
Eurofins Scientific Group is an internationally renowned testing and certification organization founded in France in 1987. The Group operates in 61 countries and regions and maintains a global network of 900 laboratories. Eurofins Biopharma Product Testing (Eurofins BPT) is the Group’s principal division dedicated to pharmaceutical and medical device testing. Eurofins BPT operates 41 pharmaceutical product testing laboratories worldwide, with biosafety testing primarily conducted at Eurofins’ Lancaster laboratory in the United States, its laboratory in the Netherlands, and its Shanghai laboratory in China. The Eurofins Shanghai laboratory was built with support from the Group’s European and U.S. facility design teams, employs a globally standardized LIMS system, and complies with GMP regulations in China, the United States, and Europe. The laboratory has obtained certifications under the CNAS and ISO accreditation systems and is equipped to perform cell bank characterization and virus clearance validation under GMP conditions, as well as microbial testing, protein structure characterization, impurity analysis, and other assays. Eurofins BPT is committed to providing customers with high-quality, fast-turnaround analytical testing services to support their pharmaceutical quality research efforts.
About Beike Pharmaceuticals
Beike (Beijing) Pharmaceutical Research Institute Co., Ltd. is a comprehensive pharmaceutical research institution that leverages its expertise in professional CRO services as its core, with the translation of scientific research outcomes into practical applications at its heart. Upholding a rigorous and pragmatic professional ethos and driven by innovation, Beike Pharmaceutical provides compliant, standardized, end-to-end, high-quality technical services to clients and institutions both domestically and internationally. Backed by superior service quality and a pool of authoritative expert talent, Beike Pharmaceutical has established long-term collaborative partnerships with numerous domestic and international pharmaceutical and vaccine companies in areas such as biosafety testing, preclinical pharmacodynamic evaluation, and clinical bioanalytical sample analysis, while continuously introducing new service offerings to meet evolving market needs.
About Hycells Biology
Shanghai Hycells Biotechnology Co., Ltd. was founded in 2021. With many years of deep expertise in cell and gene therapy and large-molecule drug development, the company is an innovative biotech firm that provides primar
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