Method Development and Validation

Our method development team specializes in developing and validating robust methods for the analysis of small molecules, proteins, peptides, and metabolites. Since 1998, MicroConstants has developed over 1,600 LC/MS/MS, HPLC/UV, HPLC/FL, immunoassay (e.g., ELISA & Meso Scale Delivery) including more than 100 non-proprietary assay methods.

We have solved difficult analytical problems including the detection of amino acids, peptides, steroids, cephalosporins, and chiral separation of various enantiomers using liquid chromatography/tandem mass spectrometry (LC/MS/MS). Despite the analytical complexity, our scientists approach every compound with creativity, innovation, and years of scientific knowledge, allowing us to uncover solutions to complex bioanalytical challenges.

method development and validation

Method Development & Validation Services

MicroConstants performs method validations, method transfers, partial validations, cross-matrix validations, full GLP validations, or any combination of them required to meet your analytical needs.

The parameters evaluated during method validations are based on the validation protocol for the study. Following validation protocols enables us to accommodate our clients’ needs for the assay validation and ensure that the appropriate regulations (e.g., guidance documents) and industry standards are being followed.

All GLP methods are validated in accordance with the USFDA Guidance for Industry, Bioanalytical Method Validation and performed in accordance with USFDA, OECD and MHLW Good Laboratory Practice regulations. Additionally, method validation protocols may be written to adhere to the European Medicines Agency (EMA) Guidelines on Bioanalytical Method Validation.

Techniques Available

  • LC/MS/MS (HPLC, UPLC, on-line SPE)
  • Immunoassays (MSD, ELISA, EIA, LIA, FIA, bead, etc.)

Non-Proprietary Assays

We have developed more than 100 non-proprietary assays for some of the most commonly tested compounds, including medications used for pain, oncology, and birth control. These methods are typically used to support studies such as drug-drug interaction, co-administration, new routes of administration, or bioequivalence studies.

View our list of non-proprietary assays to see if we have already developed the method you’re looking for.

Method Development Experience

The case studies below provide specific examples of ways we have helped advance our clients’ drug development programs:

  • Optimizing enzymatic digestion to create a stable derivative enabled us to develop an LC/MS/MS method to measure concentrations of a key biomarker directly related to the activity of a biologic. Learn more.
  • The development of a novel extraction and derivatization scheme allowed us to simultaneously determine free and covalently bound drug concentrations using a single assay. Learn more.
  • The development of a non-traditional internal standard by derivatization allowed our client to maintain their rigorous timeline without resorting to an expensive synthetic effort. Learn more.
  • Employing selective extraction in method development enabled the accurate determination of in vivo drug concentration in plasma samples collected during our client’s Phase I trial. Learn more.
  • Increasing assay sensitivity to determine drug concentration in epithelial lining fluid (ELF) samples allowed our client’s clinical trial to proceed uninterrupted, saving them time and resources. Learn more.
  • Method development, GLP method validations, and method transfers for small molecules, proteins, and peptides using LC/MS/MS, HPLC/UV, HPLC/FL, and ELISA
  • All GLP methods are validated in accordance with the USFDA Guidance for Industry, Bioanalytical Method Validation

pdf-assay-listNon-Proprietary Assay List

Request a Quote