Non-GMP/cGMP Manufacturing
Biologics have become the cornerstone of innovative therapies. However, challenges still exist from R&D to commercialization:
· Capacity Constraints: Traditional manufacturing facilities struggle to meet the flexible demands of non-GMP pilot-scale and cGMP commercialization.
· Regulatory Compliance Pressure: Tightening global requirements necessitate seamless, end-to-end compliance across development and manufacturing.
ChemExpress addresses these challenges with comprehensive, end-to-end non-GMP/cGMP manufacturing service encompassing monoclonal, bispecific, and multispecific antibodies, recombinant proteins, and antibody-drug conjugates (ADCs), leveraging advanced equipment, full-chain quality control, flexible capacity and efficient regulatory execution.
One-Stop Biologics
CDMO Service
We offer comprehensive, full lifecycle solutions encompassing monoclonal, bispecific, and multispecific antibodies, recombinant proteins, and ADCs, building an integrated service platform that covers the entire process from R&D to commercialization.
Expert Scientific Team
Our team of over 200 scientists provides comprehensive support from R&D to commercialization, enabling efficient scale-up and seamless technology transfer，effectively reducing management and transition costs.
Flexible & Efficient
Capabilities
We are equipped with reactor scales of 200L, 500L, and 2,000L, as well as precision instruments such as high-resolution mass spectrometers. Our production capabilities support all stages of drug development (Non-GMP & cGMP).
Our Services
Whether for pilot scale or GMP commercialization, our experienced team provides end-to-end support and helps you navigate the complexities of Non-GMP/cGMP manufacturing.
Our Service Scope Includes
- 1 Production Line, ~2,900 L Capacity
- Produced in 200 L, 500 L, 2,000 L Sizes
- Annual Design Capacity: 120,000L
Why Partner with ChemExpress
Scalable and Efficient Production
Equipped with internationally advanced GMP-compliant production equipment and multiple production lines, with an annual capacity of up to 120,000 L
Cutting-Edge Technology Empowerment
Advanced single-use (SUT) platforms with real-time data monitoring and analytics (PAT), enabling continuous process optimization and consistent product quality
Advanced Equipment Support
Disposable bioreactors, OEB-5 isolators, 10㎡ and 25㎡ freeze dryers, advanced isolator technology, supporting flexible production scale, reduced risk, and reliable quality delivery
Stringent Quality Control
Full compliance with GMP standards and a multilayer quality system covering raw-material qualification, in-process monitoring, and final product release
Customized Non-GMP/cGMP Manufacturing Services
Flexible Non-GMP/cGMP manufacturing with tailored commercial solutions for diverse batch sizes and program needs
Our Sites
Manufacturing Site
Manufacturing Site
Monoclonal, Bispecific, and Multispecific Antibodies, Recombinantproteins, and ADCs Process Development & Manufacturing
Related Services
Antibody Drug Discovery
At ChemExpress, we offer antibody sample preparation, developability assessment and in vitro efficacy assessment, assisting in the selection of the most suitable candidate antibodies for your drug development program.
Antibody Process Development
ChemExpress can offer comprehensive antibody process development solutions covering cell culture process development, purification process development and formulation process development, enabling rapid, cost-effective, and high-quality antibody production.
Antibody Analytical Development & Quality Control
ChemExpress focuses on the development and comprehensive documentation of analytical methods for high-quality, well-characterized biologics, providing scientific and reliable technical support for the R&D, production, and IND/BLA submission of biologics.
FAQs
We can develop and manufacture CHO cell-expressed recombinant proteins under GMP conditions.
