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Method Development & Method Transfer

Method development ensures that bioanalytical assays meet the objectives required at each stage of the drug development process.

At Biotrial, developing challenging assays is a routine BBS activity, achievable due to our experience and capabilities in innovator drug development.

We are experts in method attenuation, fine-tuning existing assays to better levels of sensitivity and overall performance including shorter run times.

Innovative Research & Development

Exenatide (Byetta), Pramlintide (Symlin), Thiostrepton: very large molecules (peptide), high complexity, low limit of detection, challenging chromatography and sample preparation

Vitamins & Hormones: Doxercalciferol, Vitamin D and analogs, Paricalcitol, Estrogens: significant endogenous levels, low response in mass spectrometry, low limit of detection

Innovative Molecule: stability, range of concentration, recovery issues, wide range of matrices (blood, CSF, pleural fluid, tissues, etc), toxicokinetic, Multiple/Single Ascending Dose, chirality

Antibodies and anti-drug antibodies & Generic drugs: pharmacokinetic, bioequivalence, bioavailability

Compounds Development

Our highly trained R&D scientists at Biotrial utilize the latest techniques, and even in cases where custom synthesis is not an option, they are adept at finding novel solutions and successfully progressing to assays with high client satisfaction and appreciation.

Small and large molecules including peptides, proteins, and antibodies.
Drug development program support from exploratory and Early Stage Clinical samples (SAD/MAD)
Proof of Concept

First-In-Human clinical study
Drug-drug interactions
Food Effect
Bioavailability
Bioequivalence and Therapeutic Drug Monitoring (Orphan Drugs).

Method Validation

Our laboratory specialists test the methods in accordance with the most recent regulatory requirements. These assays are validated according to those same stringent standards. We have validated hundreds of assays over multiple decades which have supported Regulatory Filings (IND, NDA, aNDA etc.)

Method Validation Guidelines

Bioanalytical method validation, as required by regulatory agencies at certain stages of the drug approval process, is the process of demonstrating that analytical procedures are suitable for their intended use. Our BBS SOP’s are harmonized to take both FDA and EMA guidance into account.