Zencore has a stable and efficient formulation development platform process, and completed formulations are applicable to liquid injections, prefilled syringes and lyophilized powders for injection. The dedicated formulation development team can rapidly and efficiently screen long-term stable formulations for both low-concentration and high-concentration protein products, and thoroughly evaluate the stability of the target protein in the given formulation.
From formulation screening to container-closure compatibility, development advances through a three-stage platform approach.
Members of the formulation R&D team have strong professional formulation development expertise and rich data analysis experience, and have participated in or led the development of multiple biologic formulation projects, with several having completed China–US clinical filings.
Broadly covering essentially all protein drugs in the biopharmaceutical industry, including monoclonal antibodies, bispecific antibodies, recombinant proteins, fusion proteins and cytokines.
Covering various drug product processes and workflows in the biopharmaceutical industry. Completed formulations are applicable to liquid injections, prefilled syringes and lyophilized powders, with container-closure compatibility studies also available.
High-quality customized services for clients' projects, including targeted formulation design carried out in accordance with various regulations and requirements, as well as temperature, oxidation, light exposure and other accelerated and long-term stability studies for formulation screening, thoroughly evaluating the stability of the target protein in a given formulation.
Solving two representative quality issues at the formulation level.
During formulation development for an mAb project, samples were found to turn yellow after light exposure.
Screening of suitable buffer systems and antioxidants to find the optimal formulation revealed that the yellowing was caused by the target protein undergoing oxidation reactions.
Because the investigation was completed quickly, the issue that arose in formulation development did not delay overall process development timelines, and the project advanced smoothly to pilot manufacturing.
In a bispecific antibody project, the target molecule showed high aggregate content in conventional buffer.
The cause was investigated through switching between various buffer systems as well as optimizing SEC testing methods.
The study found that the aggregates are reversible aggregates; a specific component had to be avoided during formulation development; excluding that component in formulation screening yielded better SEC performance. The project has successfully passed IND filing and begun clinical studies.
From lyophilization parameter studies to high-throughput particle size/stability characterization.
Lyophilization process parameter studies and lyophilized drug product development
Flow imaging and particle counting to characterize protein particles
Rapid assessment of aggregation trends supporting formulation and stability screening
Differential scanning fluorimetry to determine protein thermal stability (Tm)
Liquid injections, prefilled syringes, lyophilized powders — Zencore's formulation development platform selects the right formulation and process for your product.
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