IND-enabling Process Development Services

Profacgen provides the most efficient and economical process development mode, including cell culture process development, protein purification process development, formulation and process development.

Our process development is based on the concept that quality comes from design. Using our scalable upstream cell culture and downstream protein purification technology platform, we can successfully develop a process with excellent quality and high yield. We use 3L bioreactor platform for robust process development, and can be enlarged to 50L or 200L to support the rapid application of ind project. We provide a full range of process characterization services to support process validation and marketing license application.

Upstream process development

Various cell culture systems, advanced central control analysis technology and rich experience in CHO cell development can provide customers with high-quality upstream process development services. The antibody expression level in CHO cell expression system can reach 8g/L.

• Optimization and screening of CHO medium
• Formulation and optimization of replenishment strategy
• Development of culture medium clarification process (deep filtration, centrifugation, TFF)
• Technology transfer and bioreactor process scale can be scaled up to 2000L. Experience in scaling up a variety of mainstream bioreactor processes
• Process characterization

Downstream process development

We can provide high-quality downstream process development services for biological drugs such as monoclonal antibody, bispecific antibody, fusion protein and ADC. We can ensure the removal of process and product related impurities and high recovery.

• High throughput chromatography packing screening
• Optimization of chromatographic process parameters (affinity, ion exchange, hydrophobic and composite mode)
• Development of virus removal process
• Process characterization for chromatography and virus removal.
• Study on the life of chromatographic resin

Formulation process development

Focus on the formulation screening and preparation process development of monoclonal antibody, bispecific antibody, fusion protein and ADC. According to the product characteristics, quickly select the appropriate prescription, reasonably evaluate the stability of the product, determine the appropriate dosage form, and design and develop the preparation process.

• Efficient preparation process development and optimization.
• Long term stability and accelerated stability.
• Freeze thaw stability and mixing stability
• Development, optimization and scale-up of freeze-drying process
• Experiments on Influencing factors of high temperature and light, and forced degradation experiments

Analysis method development

Advanced analytical instruments can comprehensively characterize and analyze ADC, monoclonal antibody, bispecific antibody, recombinant protein and complex glycoprotein.

Comprehensive development capability of characterization methods and release methods to support product process development and verification

• Physical and chemical characterization and method development: primary structure, advanced structure, post-translational modification, heterogeneity analysis, etc
• Activity characterization and method development: antigen binding activity, Fc receptor binding activity, cytotoxicity, cell growth inhibition activity, etc.
• ADC characteristic analysis: Dar, binding sites, free drugs, etc

Research on small molecule projects: structural characterization, purity analysis, bioactivity analysis, etc

With years of project experience in Pharmaceutical Contract Development and Manufacturing Organization (CDMO), we can help you achieve faster time to market. Profacgen looks forward to cooperating with you.