Process Development
Product Description
Chime Biologics
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Country/Region:China
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Founded:2013
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On CPHI since:2023
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Certificates:4
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Employees:500 - 999
Company types
Primary activities
Categories
Chime Biologics
-
Country/Region:China
-
Founded:2013
-
On CPHI since:2023
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Certificates:4
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Employees:500 - 999
Company types
Primary activities
More Products from Chime Biologics (11)
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Product Biologics Contract Manufacturing
Chime Biologics is a leading global CDMO, focused on ensuring our customers' success in delivering innovative biologic medicines to patients across the world. Chime Biologics can support customers end to end, from pre-clinical support and cell line development through to clinical and commercial manufacturi... -
Product Cell Line Development
We offer efficient, flexible and high performing mammalian cell line development to transform your research into drug substances
Leveraging the internal expression vector engineering expertise, we have optimized and engineered the proprietary vectors with selection stringency to be used with our... -
Product Client Confidential Information Protection Policy
Strict enforcement to protect our client’s confidential information is our top priority at Chime Biologics We conduct regular and intense employee compliance training with particular focus on IP protection programs.
Our abiding commitment to confidentiality warrant us as your reliable part... -
Product Data Integrity
Chime Biologics has upgraded its IT infrastructure and adopted a series of computerized systems to ensure highest degree of data authenticity, completeness and accuracy. All computerized systems have been validated as per global regulatory requirements to assure that accurate, consistent and reliable resul... -
Product Drug product manufacturing
Liquid fill (2mL, 6mL, 10 mL, 15 mL, 20 mL, 50mL) with a state-of-art imported filling line and 100% online weigh check.
Lyophilization fill (2mL, 10mL, 20mL) with fully automated loading/unloading, a 25 m2 lyophilizer and 100% online weigh check.
Pre-filled syringe fill (1mL, 2.25mL) wi... -
Product Drug substance manufacturing
We deliver scalable biomanufacturing solutions with bioreactors from 50L to 2000L, enabling flexible capacity adjustment for projects at all development stages.All bioreactors and preparation tanks adopt single-use systems, cutting cleaning, sterilization and maintenance costs and time, shortening producti... -
Product Project Management
We collaborate with you on project objectives and our experienced project management team is responsible to deliver the target goal with highest customer satisfaction.
Our dedicated PMs will be your single point-of-contact throughout the development and manufacturing process, from project custom... -
Product Protein Science
Our protein science group provides comprehensive research services. The analytical development team manages DS/DP release and in-process analytical method development, transfer, optimization, qualification and validation, employing a stage-wise validation strategy aligned with ICH and global regulatory gui... -
Product Quality system
Our top-rated Quality System is designed to meet global regulatory expectation and follows the laws, regulations and rules for CMC activities, including: Requirements of US 21 CFR Part 210, 211, and 600 governing Good Manufacturing Practices (“cGMP”) Requirements of US 21 CFR Part 11 governing ... -
Product Regulatory Support
We support you with well-versed regulatory service, including consulting/strategic services, scientific advisory meetings, preparing regulatory dossiers and supporting for agency communication/responses preparation.
We have the capabilities and experience of IND/CTA and BLA/MAA/NDA dossier prepa... -
Product Technology Transfer
Our experienced team and well-equipped facility alloweffective, adaptable and seamless technology transfers to and from our customers at any stage of the product development lifecycle.
We offer reliable and efficient approach to transfer technology between different manufacturing scales, platfor...
Chime Biologics resources (6)
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News Interview: Biosimilars, a Market Reaching an Inflection Point - A Conversation with Frederic Bouvier
Frédéric Bouvier is a senior biopharmaceutical executive with 25+ years of experience in biologics and biosimilars across Sanofi, Fresenius Kabi, biotech startups, and CDMO organizations. His expertise spans corporate strategy, business development, portfolio build-up, and commercialization, with a strong track record of bringing biosimilars to international markets. -
News INTERVIEW WITH PETER PANG: WHERE BIOSIMILAR CMC RISK REALLY SITS TODAY
In this interview, Peter Pang discusses evolving risks and key considerations for biosimilar CMC amid the growing adoption of CES waivers by regulators. -
News Chime Biologics congratulates hope medicine inc on successful phase iii clinical dosing
March 2026, Shanghai, China — Chime Biologics, a leading global CDMO that enables its partners' success in biologics, congratulates its partner Hope Medicine Inc. on the successful dosing of the first patient in the Phase III clinical trial of HMI-115, a novel monoclonal antibody developed for the treatment of endometriosis. This milestone was achieved at the lead site, Peking Union Medical College Hospital, in China. The trial is a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the safety and efficacy of HMI-115 in treating moderate to severe pain associated with endometriosis. -
News From China, bridging biopharmaceutical innovation in Korea
Recently, the 2026 Hubei–Korea Future Cooperation Exchange Event was successfully held in Wuhan, China. As an important platform for efficient collaboration between Chinese and Korean industries and capital, the event brought together government agencies, financial institutions, well-known enterprises, and industry representatives from both countries to conduct in-depth exchanges on strategic emerging industries, with a focus on biomedicine.
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News Chime Biologics at Bio Equity Europe 2026
At this year’s BIO Equity Europe discussions held in Prague, Czech Republic earlier this month, one message resonated consistently across presentations, panels, and investor conversations: the global biotechnology industry is entering a new era defined by artificial intelligence, accelerated innovation efficiency, and strategic global collaboration.
Representing Chime Biologics, Board Director and CEO Jimmy Wei shared the company’s vision in a featured presentation titled “Turning AI into Biologics Reality”, highlighting how Chime Biologics is integrating China’s rapidly advancing AI ecosystem into end-to-end biologics development and manufacturing capabilities.
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News Chime Biologics, Daewoong Team Up for Global Dupilumab Biosimilar
Wuhan, China & Seoul, South Korea | June 2, 2026 — Chime Biologics, a global biologics CDMO dedicated to enabling partners’ success, and Daewoong Pharmaceutical, a leading South Korean pharmaceutical company, today announced the signing of a strategic partnership agreement for the development and manufacturing of a dupilumab biosimilar candidate referencing Dupixent.