Analytical Method Development, Qualification & Validation
At Althea, we believe that the primary purpose of an analytical program is not only to satisfy regulatory requirements, but to assure the success of the clinical program. Our analytical team provides such services as analytical program design, assay qualification, method writing and validation protocols and reports. Every molecule is unique and we develop methods that are tailored to its characteristics. So while some examples of methods and capabilities are listed below, we encourage you to contact us to discuss how we can develop a customized analytical program for your molecule.
ANALYTICAL DEVELOPMENT CAPABILITIES
Our scientists design and develop phase appropriate analytical methods and assays that support the understanding of your drug product as it advances into and through the clinic. Below are examples of the instruments and highly specialized techniques that Althea utilizes at various stages in a drug’s development cycle:
- Mass spectrometers (Ion Trap & Q-TOF)
- HPLC – UV/VIS, Fluorescence, RI
- Capillary Isoelectric Focusing (cIEF)
- Multi-angle Light Scattering (MALS)
- Plate readers (colorimetric, fluorescent, chemiluminescent)
- UV/VIS Spetrophotometer
Althea also has specialized capabilities that are rarely offered on a contract basis:
- Microscopic-Flow Imaging (MFI)
- Asymmetric Flow Field Flow Fractionation (A4F)
All laboratory equipment in our Camarillo facility is either on a manufacturer’s calibration program or an internal IQ/OQ/PQ program.
PROJECT MANAGEMENT & BUSINESS PROCESS
Working with you from start to finish.
QUALITY & REGULATORY
Taking pride in our history of quality.