A full range of analytical services in support of pharmaceutical and biotechnology product development is offered at Cirrus. The services include method transfer, method evaluation, method optimization, method development, method validation, rapid analysis, forced degradation, stability studies, impurity isolation, impurity identification, extractables and leachables evaluation, API characterization, dissolution testing. Our laboratories are equipped with state of the art analytical instruments used for preformulation, formulation development and product performance testing of inhaled, nasal, parenteral, oral, topical, transdermal and novel dosage forms for small molecules, peptides and proteins. Regulatory submission required data can be generated using our validated instruments.

Cirrus is registered with the FDA as a cGMP testing laboratory, and validates methods developed at Cirrus as well as methods transferred to Cirrus (that are often optimized at Cirrus in preparation for validation). Method validation includes:

Our highly experienced analytical chemists can identify potential degradation pathways and predict possible degradation products. Forced degradation studies are conducted according to ICH guidelines. Degradation products and related substances can be isolated and purified. If desired, our scientists can identify the structures of the purified degradation products and related substances.

A number of different separation techniques with various detection modes are employed at our facility:

Projects include:

The analytical scientists at Cirrus have expertise in LC/MSD (Mass Selective Detection) analysis. We have developed fast and highly sensitive methods that accelerate sample throughput yielding accurate and precise sample quantification at concentrations as low as 1 ng/mL. Using LC/MSD analysis can achieve 10-fold shorter run times than conventional methods (e.g., HPLC). The resulting benefit LC/MSD provides for our clients is an increase in turnaround time for large numbers of samples.

Cirrus offers clients biomolecular characterization by employing separation techniques such as size exclusion chromatography, electrophoresis, isoelectric focusing, total protein assays, ELISA, enzyme activity assays, secondary structure evaluations, etc.