Purification Process Development
Purification process development is a vital downstream process in biologics manufacturing, designed to separate target biomolecules—such as monoclonal, bispecific antibodies and antibody-drug conjugates (ADCs)—from impurities including host cell proteins, DNA, and aggregates. A well-designed purification process ensures that the final product achieves the desired purity, potency, and stability.
At ChemExpress, we adopt a Quality by Design (QbD) approach to establish robust and efficient purification processes. Equipped with advanced systems such as ÄKTA Pure and ÄKTA Avant, our platform supports purification process development and optimization.
Partner with us for scalable, regulatory-ready purification solutions that accelerate your path to market.
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
With our advanced purification processes, we deliver target products with exceptional purity and high yield, enabling reduced costs, enhanced efficiency, and uncompromising quality assurance.
Our Service Scope Includes
- Multiple Purification Techniques：Immobilized Metal Ion Affinity Chromatography (IMAC), Affinity Chromatography (AC),
Cation/Anion Exchange Chromatography (CEX/AEX), and Hydrophobic Interaction Chromatography (HIC) - Aggregate and Multimer Control
- Charge Variant, Host Cell Proteins (HCP), and Host Cell DNA (HCD) Control
- Chromatography Resin Selection and Replacement
- Scale-down Model
- Process Characterization
- Process Change Management and Comparability Studies
Why Partner with ChemExpress
Comprehensive Technical Support
Purification process services provided, spanning from early-stage developability assessment through IND enabling to BLA commercialization, accelerating the path to market
Rapid Response & Efficient Delivery
Rapid purification process matching based on antibody structure, equipped with advanced systems such as AKTA Pure and AKTA Avant, achieving SEC-HPLC purity ≥95% with high recovery
Cost Efficiency
A comprehensive library of culture media, chromatography resins, membrane filters, and reagents, with advanced resin selection and replacement strategies that balance efficiency, process robustness, and quality assurance
Regulatory Support
Quality by Design (QbD) principles followed, assisting clients with IND&BLA submissions across regions including China, the U.S., Europe, and other markets
Our Sites
R&D & Manufacturing site
Manufacturing Site
Monoclonal, Bispecific, and Multispecific Antibodies, Recombinantproteins, and ADCs Process Development & Manufacturing
Related Services
Cell Culture Process Development
With 24 *3L and 4 * 15L bioreactors, we offer efficient upstream process development and scale-up using versatile cell culture and analytical systems.
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.
Case Study
Yield, Purity, and Charge Heterogeneity Analysis in Antibody Purification Process Development
During antibody purification, yield, purity, and charge heterogeneity are critical factors for ensuring the final quality of the antibody. In this case study, we optimized the purification process for mAbs and BsAbs, successfully improving the yield, purity, and charge heterogeneity separation.
Using purification analysis techniques like SEC-HPLC and CEX-HPLC, we conducted a detailed analysis of the purified antibody samples. The results showed that:
• mAb yield was 72%, with purity of 99.8%;
• BsAb yield was 60%, with purity of 99.2%;
• The main peak of charge heterogeneity was 68.9% (for mAbs) and 63.4% (for BsAbs), demonstrating effective separation of charge variants.
Further analysis revealed that HCP content for both antibodies was below 10ppm, and endotoxin levels were less than 0.1 EU/mg, meeting regulatory requirements for both the U.S and China.
FAQs
ChemExpress provides purification process development for a broad range of biologics, including monoclonal, bispecific, and multispecific antibodies, recombinant proteins, and ADCs. Our platform supports both non-GMP and GMP stages, ensuring seamless scale-up from R&D to commercialization.
Scalability is built into our process design. We follow Quality by Design (QbD) principles and use scale-down models validated against pilot-scale systems. Critical parameters are closely monitored through Process Analytical Technology (PAT) to maintain consistency and performance across all scales
