Drug product manufacturing
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
-
Certificates:4
-
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 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 Process Development
Our highly-skilled teams with proven track record of scaling up expedite robust and cost-effective process development
We understand titer matters and the importance of speed and efficiency for early stage therapeutic protein development.
We adopt the Quality-by-Design (QbD) strategy ... -
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...