QUALITY CONTROL
Quality control (QC) ensures that the quality of drug products is properly tested in accordance with regulations under drug product laws as well as USA GMP regulations. Our QC staff performs development, qualification and validation of bioanalytical assays for release of final product for use in preclinical studies and clinical trials in line with written instructions and standard operating procedures.
The QC lab is fully computerized and equipped, including:
- Tekmar T25 tissuemizer
- Shimadzu HPLC with UV-VIS detector
- Revco refrigerated chromatography cabinet
- New Brunswick C25 incubator
- Hiorayama HV-100 autoclave
- Thelco oven
- Millipore Synthesis water system
- Mettler balances
- Beckman J20 and J26X high-capacity centrifuges
- Mettler pH meter
- Two laminar flow hoods
- Beckman DU800 spectrophotometer
- -80°C freezer
- P1 peristaltic pump
- Precision reciprocal shaking bath
The Institute's QC staff has worked on several significant projects, from the release test of PrAgU2/FP59 to the quality control and release tests of DT338IL3 AT1-B and DT338IL3 K116W.
Their expertise includes:
- Characterizing master/working cell banks on identity, purity, suitability of recombinant organism and stability during storage and cultivation for production
- Performing QC release and stability tests following GMP regulation to confirm identity, purity, quantity, sterility, stability, potency and safety of final drug products in conformity with GMP and GLP
- Developing new biochemical and microbiological methods for testing final products and process samples
Our QC staff interacts extensively with R&D, production and regulatory units as well as external partners and contract testing laboratories.