Since its establishment in 2017, Zencore Biologics has become an industry leader with its large-scale mammalian cell culture technology. Our team has achieved the highest expression level ever recorded in the fed-batch culture process for antibody production, reaching 15g/L.
Working with industry and academic customers worldwide, Zencore has supported the development and production of protein drugs to address unmet medical needs. Hundreds of antibodies produced using our platform technologies have advanced through various stages of clinical development. To date, Zencore Biologics has helped customers complete 19 IND and 2 BLA projects, with more than 200 project experiences overall, including 50+ monoclonal antibodies, 30+ bispecific antibodies, 20+ antibody-drug conjugates (ADCs), and 90+ other forms of recombinant proteins.
Zencore's leadership team is committed to nurturing a customer-centric culture while relentlessly pursuing scientific excellence. We value quality, leverage the best science and technology for biologic R&D and manufacturing, and provide efficient, one-stop-shop CDMO services for the biopharmaceutical industry.
Adhering to our values of pursuing facts, committing to the utmost, and striving for excellence, we aim to deliver the best and cost-effective solutions for our customers.
Turnaround Time Improvement
Zencore has a high-caliber professional management team, an enabling organization, and a highly attractive incentive structure to drive the success of our customers and employees.
Zencore senior management team members have many years of experience in MNCs and led and supported the successful filings of dozens of INDs and BLAs. Our project managers, who all have strong technical background, enable an effective and timely communication with our customers.
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.
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.
Our experienced and dedicated team at Zencore Biologics provided reliable and quality services to the anti-PD-1 antibody project from the early R&D phase and to later production phase. We were deeply involved in many aspects of the anti-PD-1 antibody development, such as process development, media formula development, engineering scale-up, process characterization, and development of the antibody production process for high-yield cell culture. Our complete service offering enabled the successful approval and listing of the anti-PD-1 antibody, Toripalimab, of TopAlliance. As of now, Zencore Biologics and TopAlliance are still cooperating on media formula optimization to lower production costs for Toripalimab for expanding the market share.