Zencore has built up an effective drug product formulation development platform. We offer to develop formulations in liquid or lyophilized dosage forms for filling into vials or pre-filled syringes. The formulation development team can determine an optimal formulation recipe efficiently. Our scientists achieve this by screening study of the target product at low or high concentration, and fully evaluating the stability of the target product in the formulation.
Based on the 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 using a DoE study.
Use the final formulation to develop suitable fill & finished process to meet the requirement of technical transfer to pilot scale under GMP conditions. The fill & finish process development includes the process parameter investigation of freeze/thaw, mixing, filtration, and filling steps, as well as the study of 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 has expertise in designing studies and data analysis experience and has developed serval therapeutics that has been used in both China and the US IND applications.
We have developed a wide range of therapeutics modalities used in biopharmaceutical industry, including monoclonal antibodies, bispecific antibodies, recombinant proteins, fusion proteinsproteins, and cytokines.
Experienced in wide array formulation processes used in parenteral in biopharmaceutical industry. The formulations are custom made for liquid vials, pre-filled syringessyringes, 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 according to country specific regulations.
Objective: To solve the issue of drug product turning yellow color.
Issue: In one of the monoclonal antibody projects, the team noticed that the target product would turn yellow after light exposure.
Strategy: Different buffer systems and antioxidants were screened to find out an optimal formulation for drug product. The reason for turning yellow was finally identified as protein oxidation.
Results: Due to the expedited troubleshooting there was no impact on the timeline of the project and the formulation drug product process was successfully transferred to manufacturing.
Objective: To find out the reason for high aggregates in formulation.
Issue: In one bispecific antibody project, aggregates were high in the common buffers.
Strategy: Various buffer system were tested and SEC-HPLC method was optimized.
Results: The team was able to find out an optimal formulation to eliminate the aggregates by excluding a certain component. The IND for this project was approved for Phase-1 clinical trial.