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.
No. 5, Dongwang Road, Suzhou Industrial Park, China
energize@bioworkshops.com
(+86) 512 6799 9700
