Sterile Injectable Drug Product Development Services
MPP Group, LLC’s drug development services are designed to help you achieve your drug discovery goals. With a staff of creative and experienced research scientists, including Dr. Michael Major who has himself developed and launched FDA commercially approved generic Injectables, we offer an effective development team that can optimize your processes and develop quality drug formulation.
Our key services includes:
- API –release test methods including assay and impurities
- RLD – analytical methods, (pH, O2, osmolality, assay, related substances, accelerated stability)
- DRUG PRODUCT – HPLC, GC, GC/HS/MS, LC/MS/MS, UV-Vis, formulation parameters, compatibly to packaging materials, preliminary forced degradation studies, terminal sterilization, identification of critical parameters, (pH, O2, temp., light), leachables, osmolality, particle size, titration, ROI, etc.
- CONTAINERS AND CLOSURES – testing
- MICROBIOLOGY – bioburden, sterility, bacterial endotoxin, microbial retention of sterile filters, flushing volume, bubble point ratio test.
- STABILITY TESTING
- TECH TRANSFER
Our approach is to identify the appropriate formulation, followed up by executing the necessary analysis and method validation. Our experienced team will develop your formulation in our cGMP lab fully supported by our state of the art in-house analytical instrumentation ensuring you have the best data and a short turn-around time to allow for quick decision making in your development process.
Let MPP Group, LLC be your partner in product approval support from development to validation of your next sterile injectable drug.