Analytical Services & QC Testing
We offer a full-service, stand-alone and integrated QC lab to support in-process, lot release, and stability studies for clinical and commercial programs.
Our capabilities
Full-Service QC Laboratory for Clinical and Commercial Products
Our Quality Control (QC) laboratory boasts state-of-the-art instrumentation. We provide comprehensive support for our clients’ clinical and commercial manufacturing programs, conducting rigorous testing for raw materials, in-process, final product (lot) release and stability studies.
In-House Analytical and Microbiology Laboratories
- Method development, transfer, qualification and validation
- Raw material, in-process, lot release and stability sample testing
- Chromatography experts across multiple platforms, including HPLC, UPLC with detection by MS, UV, PDA, fluorescence and CAD detectors
- In-house, validated methods for bioburden, endotoxin and sterility utilizing isolator technologies
- Lyophilized drug product testing
- Osmolality by freezing point depression (FPD) and vapor pressure (VP) per USP
- UV/Vis, FTIR, Karl Fischer (KF), density, viscosity, break-loose/glide force testing
- Container closure integrity testing (CCIT) by vacuum decay (Veripac)y, bioburden and endotoxin testing
- Protein assays, including ELISA, SDS-PAGE and IEF
- Compendial testing per USP/EP
Related Services
Drug Product Development
Formulation & process development for liquid & lyophilized products
Clinical Manufacturing
GMP manufacturing & distribution for clinical trials
Commercial Manufacturing
GMP Drug Product Manufacturing for International Markets
How Can We Help?
Let us apply our 37+ years of experience to help you solve your development and supply challenges. Learn more about what it means to differentiate your development process with Pyramid Pharma Services.