Small and Large Molecule
Bioanalysis for Drugs & Biomarkers

Bioanalysis is a field of analytical and bioanalytical chemistry spanning the assessment of xenobiotics, biotics, and other analytes in biological matrices. In drug discovery and development, the role of bioanalytics is quantitation of drug compounds, metabolites, and biomarkers, etc. Extensive bioanalytical services such as pharmacokinetics (PK), toxicokinetics (TK), and bioequivalence of drugs are necessary during drug R&D to acquire the essential bioanalytical data.

Both! We offer small molecule bioanalysis utilizing LC-MS/MS, HPLC Fluorescence, and HPLC – UV. Our team has remarkable experience in PK sample analysis and TK safety testing using mass spectrometric and chromatographic bioanalytics.

Our large molecule bioanalysis consists of customized assays using ELISA, Luminex, and biology kits. Other bioanalytical lab capabilities include biomarker testing, cell-based assay, immunogenicity testing, biochemical assay, and Mechanism of Action (MoA) studies.

Both! We perform robust method development by optimizing sample preparation and instrument conditions as per targeted calibration curve and other bioanalysis parameters. Our veteran team is adept at method transfer to new bioanalytics personnel or equipment. We gladly modify your method for straightforward validation or if the transfer fails due to incomplete or incorrect information.

We run fit-for-purpose full three-day LC-MS/MS or six-day ELISA method validation to evaluate selectivity, specificity, sensitivity, precision, and accuracy. Here, we examine extraction recovery, carryover, matrix effect, and matrix suppression as well as ascertain process stability. We further assess the drug and biomarker stability during sample processing, analysis, and long-term storage.

NorthEast BioLab has provided bioanalytical services in 500+ studies for Investigational New Drug (IND), New Drug Application (NDA), Generics Application (ANDA), and Biologic License Application (BLA) filings with the US FDA. Our team of veteran scientists would help put together the budget and timeline for your bioanalysis needs. Contact NorthEast BioAnalytical Laboratories today to discuss your drug development projects.

Generally, we need just four weeks for bioanalytical services such as method development and validation following the purchase order. Afterward, we need ten days for submitting your audited bioanalytical lab report with complete details of validation experiments and a few batches of sample analysis data. Please note that turnaround times for your method set-up and sample analysis may vary based on i) Specific methods (e.g., chiral separation, extended run time/duplicate injection, assay with multiple analytes / metabolites), ii) Test article or formulation – large quantities, controlled substances, specific vehicles and iii) Other Materials – required columns, well plates, and materials/matrices.

Yes! NorthEast BioLab is registered with and has been audited by the US Food and Drug Administration (FDA) multiple times for good laboratory practices. We also keep our registrations in good standing with the United States Drug Enforcement Administration (DEA) and the Connecticut State Department of Consumer Protection.

Our clients can rest assured that we are in full compliance with all relevant industry regulations, e.g., FDA validation guidance and ICH guidelines for method validation. By stringently following these regulations, Northeast BioAnalytical Laboratories seamlessly completes each study that we accept. Please contact us if you would like additional proof or documentation of our credentials and certifications.

As your trusted bioanalytical lab, NorthEast BioLab flexibly partners with a vast network of affiliates to deliver requested analytical testing, preclinical, and clinical CRO solutions. With us, you’ll not only get access to first-class, client-focused bioanalytical services but also recommendations for preferred life sciences consultants and in-vivo, pathology, and materials providers. Speak with our veteran team to get head-start on your study and beat competitors to market.