Bioanalytical
Bioanalytical
At Noah Therapeutics, our advanced Bioanalytical Research Laboratory plays a critical role in supporting drug development initiatives. The laboratory is designed to function both as a stand-alone research unit and as a fully integrated end-to-end bioanalytical support service, enabling seamless support for clinical research and drug development programs.
Noah therapeutics boasts a high-quality bioanalytical research department, headed by a highly experienced leader and a competent team. The department is equipped with all the standard methods that offer specialized support to drug developers in optimizing their drug candidates, assessing their safety and efficacy and meeting the regulatory standards. The bioanalytical research team has the capability to handle and support various phases of drug development, from preclinical to clinical to post-marketing studies.
❖ Bioanalytical lab spreads over 4000 square feet area in separate building.
❖ Six LC-MS/MS Systems SCIEX API5500[2], API4500 [2] & API4000[2]
❖ Audit trail and data security systems
❖ Sample preparation laboratory equipped with centrifuges, SPE manifolds, refrigerators, vortex mixtures, pH meter, ultrasonic bath, Nitrogen evaporator and fume hoods with restricted access.
❖ Mettler Toledo Micro / Analytical balance.
❖ Dedicated area of handling highy sensitive and photo sensitive molecules or methods.
❖ MD/MV of simple and complex drugs and metabolites as per regulatory requirements
❖ GLP, ALCOA Plus and 21 CFR Part 11 complaint
❖ Deep Freezers -70°C, [04] & Freezer – 20°C, [02] & Refrigerator [2]
❖ Separate pharmaceutical refrigerators for storage of working/ reference standard and stock solutions
❖ Centralized Monitoring of Temperature
