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Who are we?
JOINN Biologics US was founded in 2018, located in beautiful San Francisco Bay Area at the JOINN Innovation park.
We are a full-service premier Contract Development & Manufacturing Organization which provides you with quality, value and speed to market from DNA to Drug Product. We offer a comprehensive range of services across all the phases of the drug life cycle, which includes Cell Line Development and MCB Manufacturing, Process and Analytical development, Formulation Development, Drug Substance Manufacturing and Drug Product Development services, along with packaged services for material production and IND enabling PKPD TOX services, all under one quality system supported by global regulatory services. Our scientists and engineers bring over two decades of development experience across a broad spectrum of both platform and novel technologies.
JOINN Laboratories, the parent company of JOINN Biologics, is the leading clinical and nonclinical CRO with facilities in China and US. With an excellent track record in the field for more than two decades, JOINN Labs is the first pre-clinical CRO inspected by the US FDA for GLP compliance in China and issued its IPO in Shanghai Stock Exchange in August 2017.
Dr. YuXia Feng is our president of both JOINN Laboratories and JOINN Biologics.
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Dr. He, Ph.D.
Dr. He has more than 20 years of experience in the discovery and development of innovative protein and monoclonal antibodies therapy. He has working experience in world renowned pharmaceutical companies, such as Novartis, Wyeth and Pfizer. Dr. He is a subject matter expert and industry leader in developability analysis and protein drug characterization for biologics development. As a team leader, he has led and directly participated in the development of multiple biomacromolecules that have been successfully approved for clinical and commercial development.
Dr. Chen, PhD
Dr. Bao-Lu Chen is Global Chief Operating Officer for Joinn Bio US Inc and JoinnBio China. Bao-Lu has close to 30 years of industry experience in CMC operation, quality management, and regulatory filing. Bao-Lu gained biologics and cell therapy product development experience by working in the US for 20 years at Amgen, Chiron, and Sangamo. He then went to China and worked there for about 5 years. As COO worked at two companies, he completed development and manufacture of several mAb and biologics from cell line construction to IND filing. As Chief Quality Officer and Sr. VP at Shanghai Henlius, he contributed to the successful development of several mAb products from phase I to commercialization. Among them, one received China NDA approval, and another one received both China NDA and EMA MMA approval. He helped two Chinese companies to obtain QP declaration for their product GMP manufacturing. His regulatory experience includes successfully filing several INDs, CTAs, and MAAs to China NMPA, FDA, EMA, and other regulatory agencies.
Dr. Vo, PhD
Senior Director, Head of Quality Control
Loc is a biopharmaceutical professional with over 20 years of experience in Quality. Loc was the Director of BioMarin’s Quality Control Analytical Technologies department where he managed four quality subgroups: 1) assay optimizations/validations/transfers, 2) special studies (manufacturing investigations and process comparability studies), 3)critical reagents and reference materials, and 4) in-country testing and CMO technology transfers. He was a major contributor in the global authorization of seven drug products from clinical to commercial stages. Loc was a major author and reviewer of the CMC sections for multiple product lines. Loc has participated in multiple on-site FDA and EMEA inspections and served as the Quality representative for global regulatory inquiries.
Dr. Jiang, PhD
Senior Director, Cell Line Development
Wen-Rong has 20 years biopharma industry experience in R&D and is an expert in antibody drug & cellular model development. She was one of the major contributors to several anti-HCV programs advanced into clinical studies (Roche), and led a number of efforts in targeted cancer therapy using ADC, bispecific Ab, T-cell and macrophage redirecting technologies (Pfizer), created an array of cancer cellular models and stable cell lines using various mammalian cell engineering techniques. Wen-Rong established Cell Line Development Function and workflow at JOINN Bio, and has successfully completed multiple stable cell line development client projects.
Dr. Yang, PhD
Senior Director Process Development
Shumin has over 20 years’ experience with recombinant protein production, including: eight years of experience working on the development, scale up, and transfer of MFG processes from 500L to 12,000L scales for multiple therapeutic recombinant proteins at CDMO Boehringer Ingelheim (Fremont, CA) and Catalent (Bloomington, IN).
Senior Director, Manufacturing
Mr. Jon Stritch has over 25 years of experience in biotech development and production from cell banking to fill/finish, including roles at Chiron, Calypte Biomedical, and XOMA. Additionally, he has experience in tech food scale-up and production at Ripple Foods. His expertise includes protein manufacturing, facility design, CMC project management, aseptic processing, process scale-up, and tech transfer.
Director, QA Validation
Mr. John Vuong has developed a very strong background in the area of setting up the GMP Manufacturing infrastructure and Quality System at Biotechnologies, Pharmaceuticals, Medical Devices, and CLIA labs during the past 20 years. John brought products from conception through to commercialization and improved manufacturing efficiency. In addition, John has over 20 years experiences in regulated environments successfully leading groups in Manufacturing, Product Transfer, Manufacturing Technical Support, Process Development, QC, Validation, QA and RA. He has provided comprehensive training to onsite staff regarding operational procedures, cGMP and compliance to FDA guidelines and has completed product transfers for Chiron Corporation, Novartis Corporation, Smithkline Beecham Corp, Quest Diagnostics Corp, Thermo Fishers, and Ortho Diagnostics. With Biochemistry degree John brings a unique technical background to the complex environment of GMP Operations.
Director, Facility Operations
Chris has over 25 years of experience in all aspects of facility operations. From Internationally Certified Facilities Manager in the R&D/Biotech/Chemical Manufacturing Field to PMP Silver Certified Project Manager with hundreds of projects successfully completed. Chris oversees the day-to-day operation and maintenance of control components, repairs, control sequences, documentation, network security, and hiring and training of new staff.
Member of core ISO 50001 Energy Management team working closely with Sustainability to improve energy saving goals at the lab.
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Where we make the magic happen.
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Where we make the magic happen.
JOINN Biologics’ upstream manufacturing provides on time, high quality, compliant cGMP production services from vial to final production vessel using stainless steel bioreactors up to 1000L production capacity, and single-use bioreactors up to 500L production capacity.
The upstream manufacturing suites are equipped with a wide variety of cell culture production equipment as well as many advanced in-process testing technologies that include:
- Rocker-based bioreactors
- 200L and 500L Single-use bioreactor systems
- 50L Sartorius Stainless Steel Bioreactor systems
- 200L and 1000L ABEC Stainless Steel Bioreactor systems
- Cell culture analyzers: Vi-Cell, Cedex Bio analyzer, pH/gas analyzer, osmometer, etc.