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Analytical Development

To support development of biologics, Bioworkshops has developed all of the standard analytical methods for physicochemical analysis, bioassays and safety tests that are needed from pre-clinical through to cGMP manufacturing. Our scientists are experienced in method development, qualification and validation and deliver complete methods for product from pre-clinical to cGMP manufacturing.

Primary Structure	Advanced Structure	Charge Heterogeneity	Bioassay	Product Related Impurities	Process Related Impurities
A.A. sequences	Free Thiol	N-glycosylation Distribution	Binding Affinity	Purity	Host Cell DNA Residue
Molecular Weight	Disulfide Bond	Charge Heterogeneity	Cell Based Assay	Post-Translational Modification	Host Cell Protein Residue
N-glycosylation Site	Thermostability		ADCC/CDC		Protein A Residue

Typical Analytical Development

2~3 weeks

Technology & Materials Transfer

Doc. Review

Q & A

Research materials transfer
Physicochemical 3~4 weeks
Potency 8~12 weeks

Reproducibility or Development

Assay Development

Physicochemical

ELISA binding

Cell-based potency
12~16 weeks

Qualification & Comparability

Assay Qualification

Support PD testing

SOP Drafting
4~8 weeks

Report & Tech Transfer

AD Report

Technology Transfer to QC

Technology Transfer to Clients