CQDMO Services
Relying on its internationally advanced production processes, rigorous quality management system, and extensive experience in IND submissions, Jiuzhitang Maker has established a CQDMO (Contract Quality, Development & Manufacturing Organization) service platform specializing in stem cells and regenerative medicine. This platform provides hospitals, pharmaceutical companies, and research institutions with end-to-end solutions—from preclinical studies all the way through commercial-scale manufacturing—including services such as stem cell bank establishment, process development and optimization, quality control and quality research, regulatory filing and registration support, as well as comprehensive consulting services. As a result, clients can more efficiently advance their drug development projects and accelerate their products' journey to market.
Platform Advantages
Globalized hardware and software capabilities
Ensuring high-quality and compliant products and services
Production platform:A 4,800㎡ production facility compliant with China-US-EU GMP standards, featuring 4 independent Class B+A cleanrooms, and equipped with a robust quality management system that covers the entire lifecycle of pharmaceutical products.
Testing platform:Biosafety Level 2 laboratory receives accreditation certificate from the China National Accreditation Service for Conformity Assessment (CNAS).
Production Capacity:Having accumulated over 100 batches of sterile pharmaceutical production experience, we possess scalable manufacturing capabilities for both multi-source stem cells and exosomes.
Multi-million-level stem cell expansion capability
Breaking the Bottleneck in Scalable Production of Stem Cells
Our highly efficient R&D team has successfully scaled up the production of 10 million stem cell therapy products derived from a single donor’s bone marrow tissue, enabling us to build high-quality seed and working banks for our clients—and meeting their future needs for large-scale, commercial-grade manufacturing.
Extensive clinical project experience, efficiently driving project progress
An innovative clinical team successfully facilitated the approval of three groundbreaking Investigational New Drug (IND) applications for pioneering stem-cell-based therapies. We support our clients’ personalized needs by offering comprehensive services, including IND application strategy planning, CTD document preparation, and IND submission agency assistance.
Solution
Innovative pharmaceutical company
Requirement:Accelerate IND submissions and mitigate CMC-related risks
Plan:Offering end-to-end services from process development to IND submission, reducing the approval timeline by more than 30%.
Research institutions and universities
Requirement:Translating research findings into the clinical trial phase
Plan:Providing GMP-like laboratories that support quality standard establishment, process validation, and scale-up activities.
Hospital
Requirement:Translating research findings into the clinical trial phase
Plan:Providing research-grade stem cells, GMP-compliant production facilities, and cell testing services, among other offerings.
Related Business
Jiuzhitang Maker offers three specifications of its Stempanacel® product, with cell counts of 1 million, 15 million, and 50 million cells, respectively. Customized cell volumes tailored to specific user needs are also available upon request.
Learn more
Jiuzhitang Maker’s human neural stem cell injection is a clinical-grade allogeneic neural stem cell product, manufactured under GMP-compliant conditions according to pharmaceutical production standards, on a proprietary cell preparation platform. It boasts a purity level exceeding 99% and is free from exogenous pathogenic microorganisms such as HIV, HBV, HCV, mycoplasma, bacteria, and fungi. The product meets the stringent quality criteria set forth by both the U.S. FDA and China’s NMPA for clinical trials.
Learn more
Jiuzhitang Maker's cytokine lyophilized powder is derived from clinical-grade cells and meticulously prepared on a large-scale production platform adhering to GMP standards—ensuring it meets pharmaceutical-grade quality. This results in enhanced potency and superior safety. With its versatile applications spanning aesthetic repair, cosmetic enhancement, and even innovative cosmetic ingredients, the product holds immense commercial potential, positioning itself as a key driver for groundbreaking advancements in cell-based cosmetic raw materials and applications.
Learn more
Jiuzhitang Maker's exosomes are derived from clinical-grade stem cells and are rigorously prepared on a large-scale production platform adhering to GMP standards—ensuring they meet pharmaceutical-grade quality. As a result, these exosomes exhibit enhanced activity and superior safety profiles. With their versatile applications spanning drug research and development, regenerative aesthetics, and innovative cosmetic ingredients, exosomes hold immense commercial potential and are poised to drive new advancements in the field of stem cell-based cosmetic raw materials and applications.
Learn more
The Jiuzhitang Maker R&D and Production Platform offers customized stem cell-related services—ranging from pharmaceutical development to commercial-scale manufacturing—for hospitals, research institutions, and emerging companies. This platform effectively helps clients streamline project timelines, reduce costs, and accelerate the regulatory approval and commercialization of innovative stem cell-based drug products.
Learn more
Here is the title—h1 placeholder text
Copyright © Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd.
Powered by: 300.cn SEO | Privacy Policy