At Zencore Biologics, the extensive experience in scale-up engineering and unparalleled process model design capabilities, ensure success in the early process development. Perfect integration of cell line development, media development, host cell engineering and process development technologies by our process development team results in high quality, high titer, stable, consistency and expression of the product. Which results in improved timeliness in process development and lowering costs for our customers. 

Advanced cell line development and culture media development platforms utilized at Zencore enables delivering quality products. 

Our industry-leading cell line development platform was used to successfully develop several biosimilars with matching similarity the original biologics. The knowhow to develop in-house culture media, makes it possible to adjust the various culture media components that may impact the product quality and similarity.

Case Sharing

In the course of developing biosimilar to Avastin for Zhejiang Teruisi Pharmaceutical Co., the application for clinical trial drug was approved by FDA without supplement. This was made possible by the high consistency of various key quality parameters with the original biologics. This biosimilar application holds the record of quickest IND application cycle to the US FDA and direct clinical trial for biosimilar produced by any Chinese biopharmaceutical company.

Our process development team, at Zencore Biologics, have extensive experiences in downstream purification and formulation development. Our proven downstream mAb purification platform has been successfully used in developing many of our client projects. In order to  provide the best formulation services, we have established advanced high-throughput formulation development equipment and high concentration analytical instruments. Currently, using high concentration formulation platform (> 150 mg/mL) we have provided services to many of our clients. 

In March 2020, Zencore Biologics introduced the first analytical ultracentrifugation equipment (AUC) in China. It has performed aggregate analysis, similarity analysis for biosimilars, batch consistency research and other technical services for mAbs, bi-specific antibodies, ADCs, vaccines and many other products. Thanks to the introduction of innovative microfluidic technology, next generation ELISA method, a patent for new Coronavirus enzyme linked immunosorbent kit based on microfluidics was issued by the State Intellectual Property Office and entered the substantive examination stage in January 2021 ( Publication No: CN112180084A ) .

Zencore Biologics fully embraces Quality by Design principles – (QbD) during CMC development. Late stage products that are in phase II and III process development, are taken through Zencore platforms for process characterization and verification. We have supported multiple pharmaceutical companies locally as well as abroad in their scale-down model development and process characterization to support late phase clinical manufacturing. Zencore Biologics is one of the few companies in China that has experience in supporting clinical and regulatory activities for our customers.

The core team members have extensive experience in quality control, quality assurance, and IND filing at home and abroad. Our Team members have completed more than 40+ IND and BLA filing worldwide. These include successful filing of biologics IND & BLA to NMPA and FDA.

Bispecific antibody or multi-specific antibody are one of the key focused areas for future antibody drug development. Our team members have years' of industry experience in discovering and developing various forms of multi-specific antibodies. We have over 20 bi-specific or multi-specific antibody programs either finished or on-going at Zencore.

Majority of the team members have experience in commercialization of therapeutic protein (mAbs etc.), which includes designing a efficient manufacturing process, GMP manufacturing & compliance in the United States, Europe, Asia and China. Their extensive experience will ensure flawless operation of our cGMP production lines for biologics and media.

Using our proprietary media development platform, Zencore development team is able to adjust any media component according to the characteristics of the product and cell line. The media manufactured at our GMP media manufacturing facility has an average titer at harvest of more than 6g/L, and as high as 12g/L. Zencore manufactured media quality meets all requirements of domestic and foreign regulations and standards.