Zencore has established an robust drug product development platform. Our offerings include the development of both liquid or lyophilized dosage forms suitable for vials or pre-filled syringe application. Our drug product development team excels in identifying the optimal formulation recipe through an efficient process. This is achieved by conducting a comprehensive screening study of the target product at low or high concentrations, followed by a thorough evaluation of the product's stability within the formulation.
Leveraging our profound understanding of the physical and chemical properties of the protein, a preliminary formulation is identified after two rounds of screening for pH, buffer systems, protectants, and surfactants. The composition and concentration of the final formulation will be evaluated via a Design of Experiment (DoE) study.
Utilizing the final formulation, we develop a suitable drug product process to meet the requirement of technical transfer to pilot scale under GMP conditions. The drug product process development includes the study of process parameters in freeze/thaw, filtration and filling, and the lyophilization process.
Primary packing material could be selected from Zencore's platform material. Compatibility study or container closure integrity test could also be conducted by clients' request.
Manufacturability assessment for candidate molecular using a rapid platform method
Drug product formulation development (for aqueous injections, pre-filled injections, and lyophilized powder)
Fill & finish process development (aqueous injection, pre-filled injection, and lyophilized powder)
Primary packaging material screening and compatibility studies
In-use compatibility and stability studies to support toxicology study and clinical administration
Technical transfer to pilot scale for fill & finish process
Long-term, accelerated, or stressed stability studies for drug product
Formulation development team boasts a wealth of expertise in study design and data analysis. We has developed numerous therapeutics that have been utilized in IND applications in both China and the United States.
We have developed a wide range of therapeutics modalities used in biopharmaceutical industry, including monoclonal antibodies, bispecific antibodies, recombinant proteins, fusion proteins, and cytokines.
Experienced in wide array formulation processes used in parenteral in biopharmaceutical industry. We specialize in creating custom formulations for liquid vials, pre-filled syringes, and lyophilized vials. The compatibility of primary packaging material is performed after the determination of final formulation.
Customized service to provide optimal formulation development for our customers. Accelerated and long-term stability tests for temperature, oxidation, light exposure, and other factors are evaluated for stability in compliance with country-specific regulations.
Objective: To solve the issue of drug product turning a yellow coloration
Issue: In one of the monoclonal antibody projects, it was observed that the target product would exhibit yellow following exposure to light
Strategy: The cause of turning yellow was finally identified as protein oxidation. Different buffer systems and antioxidants were screened to find out an optimal formulation for drug product.
Results: Due to the expedited troubleshooting, there was no impact on the timeline of the project and the formulation was successfully transferred to pilot production team.
Objective: To investigate the cause of high aggregate levels in the formulation.
Issue: In one bispecific antibody project, it was found that aggregates were significantly high when using common buffers
Strategy: Various buffer system were tested and SEC-HPLC method was optimized.
Results: The team succeeded in identifying an optimal formulation that significantly reduced the aggregates by eliminating a specific component. The IND application of this project was approved for Phase-1 clinical trial.
