Bioanalytical Development And Testing

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. Our Bioanalytical Development and 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