Quality Control
MassBiologics' Quality Control (QC) group performs or oversees the testing and release of all raw materials, cell banks, in-process, product release, and stability samples. The QC group also performs the routine monitoring of our cleanroom environments, cGMP clean utilities and equipment cleaning.
The team is ready to share our experience and capabilities in the following areas:
- Assay transfer, qualification and validation
- Development and qualification of assay reagents
- Immunoassays, cell-based and in vivo bioassays
- Development and execution of stability programs
QC capabilities include:
- UV & Fluorescence spectroscopy
- UPLC & HPLC assays for protein quantitation and purity
- FTIR
- PAGE and CE
- IEF and cIEF
- ELISA
- Host cell protein & host cell DNA assays
- Residual protein A assay
- qPCR
- Microbiological testing & identification
- Sterility (dedicated sterility suite, FDA inspected and approved)
- Endotoxin (gel clot and kinetic)
- Particulate Matter (HIAC)
- Total Organic Carbon
- Atomic Absorbance Spectroscopy
- Container Closure Integrity (Dye Intrusion)
- Osmolality
- Cellular Toxicity Assays (Cytopathic effect)
- Cellular-based potency assays (luciferase/fluorescence)
- Serological Assays (Anti-drug antibody measurement, measure of drug concentration by ELISA in serum matrix)
- Assorted compendial assays