Zencore Biologics has established an exceptional upstream process development platform, which is well-equipped and operated by an experienced team. Our upstream PD platform specializes in developing stable, high-yield, robust, and transferable processes, representing one of Zencore’s core technological competencies.
Embracing an unwavering commitment to continuous innovation and improvement, we strive to explore and adopt cutting-edge technologies for cell culture processes. Our dedication lies in providing our customers with effective and robust solutions, ensuring the product quality, process efficiency, and reasonable COGS (Cost of Goods Sold). These key characteristics enable us to meet the diverse needs of global clients.
In 8-10 weeks, perform multiple rounds of process development from 250-mL shaker flask to 20-L bioreactor
Leveraging our thorough understanding of cell metabolism, bioreactor performance, protein quality attributes, and extensive cell culture development experience, we have built a superior upstream process development platform in the world.
Our cell culture platform, combined with proprietary media and high-quality CHO-K1 cell line, lets us to rapidly develop processes in 2-L, 5-L and 20L bioreactors. The processes developed are robust and reproducible. So far, 100% of the projects have been successfully scaled-up to 200-L, 500-L or 2,000-L.
Our excellent scientists and technical experts have developed high-quality and efficient technology transfer processes, which will enable the accelerated timelines to IND.
Quality fusion protein highly similar with originator
Fusion protein highly similar with originator protein was produced using the process developed in house. The process was developed using an integrated platform, coupled with medium development / optimization and critical process parameters studies of upstream and downstream processes.
Science and risk-based, fully implementation of QbD
Zencore aims at perfecting the process development to provide our clients with the best services possible.
Any process should be robust, reproducible, scalable with desired product quality and required bioreactor throughput. Our well-trained scientists will leverage their expertise and our cutting-edge instruments of cell culture to develop a high quality and robust process.
The practice of quality by design (QbD) has been integrated into the entire cell culture process development activities. Our scientists will search for the best process solution during product optimization, conduct thorough risk assessment, and propose suitable mitigation strategies. The team will carry out the identification of critical process parameters (CPPs), key process parameters (KPPs), medium screening and optimization, control strategy definition and process verification, etc.
Per our customer request, Zencore's development platform can be used to achieve certain quality attribute targets such as matching a specific charge variants profile, aggregates or fragments reduction, achieving a specific glycosylation profile, etc. Furthermore, the following upstream process parameters: media selection, temperature, culture duration, and PH, can also be optimized.
• Clone screening
• Media screening
• Critical process parameters identification
• Improvement of protein expression level
• Product quality improvement
• Perfusion process development
• Process technology transfer and scale-up
Issues: In a biosimilar mAb process development, compared with the glycosylation profile of the originator, it was found that the G0F component was higher and galactosylation content was lower in the molecule.
Strategy: Leveraged our thorough understanding of metabolic pathways in CHO cell, several engineering strategies were utilized to adjust the process parameters and proprietary medium components to achieve desirable glycosylation profile successfully.
Results: With the optimized process, project molecule has a highly similar glycosylation profile as well as other quality attributes to the originator molecule.
Issue: Fragments are always generated during the cellular synthesis, secretion and purification for bi-specific antibodies due to its complex molecular design and structure. Since the fragments will not be removed effectively during downstream purification process, it is necessary to strictly control the fragmentation during the cell culture stage.
Strategy: Reduce the molecular fragmentation by a combination of upstream process development and medium optimization.
Results: Fragmentation was reduced by nearly 50% with the optimized process, the target quality attributes were achieved, and the product titer increased.
