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Analytical Development

Analytical Development

Bioworkshops has established a battery of in-house analytical platform methods that meet the requirements of physical and chemical analysis, biological activity analysis or safety testing in all stages of biological products from preclinical research to cGMP production. Our researchers have extensive experience in analytical method development and validation.

The analysis platform includes Thermo Orbitrap Exactive HF-X, Protein Simple Maurice, SCIEX PA800 Plus, Waters H-Class UPLC, Thermo Vanquish UHPLC, Thermo CAD detector, Octet intermolecular interaction instrument, MD M5e microplate reader, and Roche 480 qPCR instruments. With this advanced equipment Bioworkshops is able to provide develop and validate analytical methods for comprehensive product characterization, in-process testing, and finish product testing for biologics such as monoclonal antibodies, bi-specific antibodies, fusion proteins, and ADCs.

Primary structure Advanced structure Charge Heterogeneity Bioassay Product Related Impurities Process Related Impurities
A.A sequences Circular Dichroism N-glycosylation distribution Binding affinity Purity (SEC-HPLC、CE-SDS) Host Cell DNA residue
Molecular weight Thermostability Charge heterogeneity Cell based assay Post translational modifications (isomerization, deamidation, oxidation, etc.) Host Cell Protein (HCP) residue
N, C amino acid sequence ADCC/CDC Hydrophobicity profile Protein A (ProA) residue
N-glycosylation Affinity determination Bacterial endotoxin
Free sulfhydryl
Disulfide bond pairing

Typical Analytical Development

Step 1

2~3 weeks

Technology & Materials Transfer

Doc. Review

Q & A

Research materials transfer

Step 2

Physicochemical 3~4 weeks Potency 8~12 weeks

Reproducibility or Development

Assay Development


ELISA binding

Cell-based potency

Step 3

12~16 weeks

Qualification & Comparability

Assay Qualification

Support PD testing

SOP Drafting

Step 4

4~8 weeks

Report & Tech Transfer

AD Report

Technology Transfer to QC

Technology Transfer to Clients

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