Methods & Process Development

Methods Qualification & Validation

We can develop, qualify and validate your methods to meet cGMP, cGLP or cGCP requirements.  This service applies to a variety of methods including but not limited to ELISA, SDS-PAGE, HPLC, Clotting and Chromogenic Substrate Assays, Residual Moisture Determination, and Osmolality Measurement.  Typical validation parameters include accuracy, precision, intermediate precision, specificity, linearity, limits of detection and quantification, range and robustness.

Methods Optimization

Using Failure Mode and Effects Analysis (FMEA) we can discover inefficiencies and potential problem areas in a process and improve on these areas.  The goal is to reduce or even eliminate out-of-specification (OOS) results to increase yield and ultimately save you time and money.

Process Development

We can help with purification and quality control processes.  Tap into our 20+ years of experience with protein purification and characterization to develop a protocol that is optimized to meet your goals.  Once a process has been developed and validated we can continue to run it for you or assist you in transferring the technology to a laboratory of your choice.