Our Formulation Development team offers services to develop customized formulations for different biologics, such as monoclonal antibodies, bi-specific antibodies, single-chain antibodies, nano antibodies, recombinant proteins, and fusion proteins . Key capabilities include filling process and formulation characterization (DoE), molecule developability and high concentration formulations.
Fast-track platform to support biologics’ developability evaluation.
Pre-formulation and formulation to support clone selection, process development and degradation pathways identification.
Rapid buffers and excipients screening by DSC, particle counting and/or spectrometry.
Container/closure selection and integrity test.
Filling process development, including freeze-thawing, dilution and mixing, holding times, filtration, filling rate and so on. Technical transfer and scale-up to support for GMP fill- & finish.
Long-term, accelerated, in-use stability and forced degradation studies will carried out base on the policy from ICH, ChP and so on.
Lyophilization process development.