Therapure operates under the principle, -Start with us, stay with us,' meaning that we provide a range of services to our clients minimizing logistics and creating one point of contact.
Supporting every successful drug development program are reliable and robust analytical methods. These methods must be designed to support in-process analysis, bulk release testing, drug product release testing and stability monitoring programs. Who can provide the required support for your method development, qualification and validation needs? Therapure is your trusted partner for developing and validating analytical methods.
Therapure understands the importance of your critical methods and how they support your unique program.
Our facility has 10,600 ft2 of fully equipped analytical development and quality control testing space. Ourand quality control teams have extensive experience in the development, qualification, and validation of cGMP compliant analytical methods, including complex biological activity assays. Immediately following project kick-off, our analytical development team begins transferring your established assays or developing products specific assays from scratch. Prior to product manufacturing, the analytical methods are transferred to Therapure's Quality Control department where they are qualified (for Phase I-II Clinical programs) or validated (for Phase III/Commercial programs) through mutually approved protocols.
Our experience in method development, optimization, qualification and validation includes:-
Physiochemical analysis
Raw material methods (custom or compendial)
Compendial methods (USP, Ph. EU, JP, NF)
Protein concentration (UV-Vis, fluorescence)
Spectrophotometry
Nephelometry
Colorimetric
Gel electrophoresis
SDS-PAGE
IEF
2-Dimensional
Flow cytometry
ELISA
Cell based bioassays
High performance liquid chromatography
Standard (SEC, RP, Ion Exchange)
Specialized
Total organic carbon
Gas chromatography (headspace & liquid)
Microbiological testing
Microbial identification
Endotoxin analysis (gel clot)
Particulate matter
Sterility
Bioburden
Protein characterization
Amino acid analysis
Peptide mapping and glycoform analysis
Extinction coefficient studies
Liquid chromatography mass spectroscopy (LC-MS)
Blood/plasma testing
Nephelometry
HemoX (P50) analysis
Co-oximetry
Phospholipids
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