Apr 13, 2023 1
Helping to accelerate biopharmaceutical development from discovery to the clinic
Apr 13, 2023 2
USP Sciences
Apr 13, 2023 3
DSP Sciences
Apr 13, 2023 4
Assay Sciences
Apr 13, 2023 5
• Identity / Integrity– SDS-PAGE, WB, IEF
• Concentration– Elisa, RP-HPLC
• Aggregation / Particle size– HP-SEC
• Glycan profiling– NP- and AEX-HPLC– MALDI-MS (partner)
• Potency– Cell based in-vitro activity assays
• Residuals– Eg: hc-DNA (Q-PCR)
Quality Control department
to ensure a certain level of quality in a product or
service
GMP & BSL-II+
Apr 13, 2023 6
GMP facilityCRO and CMO
Biosafety level II+
TCID50 potency assay
Apr 13, 2023 7
Batavia Bioservices
Apr 13, 2023 8
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