Method Development Validation

Customized Method Development and Validation for Your Bioanalytical Needs

We perform method validations, method transfers, partial validations, cross-matrix validations, full GLP validations, or any combination of them required to meet your bioanalytical 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 we follow the appropriate regulations (e.g., guidance documents) and industry standards.

Tell Us About Your Project

What are your specific assay needs? Let’s schedule a conversation to review your questions and requirements with one of our scientists.

Small Molecule Method Development and Validation

Our method development and validation team specializes in developing and validating robust methods for the analysis of small molecules, proteins, peptides, and metabolites. We have solved difficult analytical challenges, including the detection of amino acids, peptides, steroids, cephalosporins, and chiral separation of up to four enantiomers using liquid chromatography/tandem mass spectrometry (LC/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.

Large Molecule Method Development and Validation

We excel at the design and development of immunoassays “from scratch” for novel drugs and biomarkers, including challenging projects. About 90% of our ADA methods and ~50% of PK assays are developed in-house. Sometimes, using a commercially available kit or antibodies can make financial and logistical sense, and our team is skilled at identifying the best options, with the greatest analytical sensitivity and specificity, at the least expense.

A crucial first step in method development of large molecule bioanalytical assays is the procurement of critical reagents of the highest quality. If the client is unable to supply key proprietary reagents, such as purified antibodies or specificity controls, we will identify reliable sources. This includes subcontracting the generation of drug-specific antibodies, with testing of intermediates and final products (e.g., early animal bleeds, pre- and post-affinity purification products, etc.).

Method Development and Validation Techniques

  • LC/MS
  • HPLC/Fluorescence
  • Immunoassays (MSD, ELISA, EIA, LIA, FIA, bead, etc.)

Matrices Analyzed

We have experience analyzing API and metabolites in the following biological matrices:

  • Whole blood
  • Serum
  • Plasma
  • Dried blood spot (DBS)
  • Urine
  • Fecal homogenate
  • Spinal cord homogenate
  • Tumor homogenate
  • Aorta homogenate
  • Ocular tissue
  • Vitreous fluid
  • Aqueous humor
  • Skin tissue
  • Brain tissue
  • Muscle tissue
  • Lung tissue
  • Liver tissue
  • Kidney tissue
  • Synovial fluid
  • Gastric fluid
  • Cerebrospinal fluid (CSF)
  • Bronchial lavage fluid
  • Sputum
  • Endothelial lining fluid (ELF)
  • Bone marrow
  • Perilymph

Non-Proprietary Assays

We have developed more than 100 non-proprietary assays for various 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 need.

Equipment and Software for Method Development & Validation

BioAgilytix is one of the largest bioanalytical LC/MS laboratories on the West Coast of the United States. The instrumentation at our facilities is state-of-the-art and constantly upgrades equipment to remain at the forefront of the industry.

Featured Case Study

Simultaneous Determination of Drug Concentrations

Learn how the development of a novel extraction and derivatization scheme allowed us to simultaneously determine free and covalently bound drug concentrations, using a single assay.

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