Science based Services

NorthEast BioLab has distinct track record of advancing your research and GLP bioanalysis services from drug discovery to development and beyond.

Full Range of Solutions

NorthEast BioLab provides comprehensive clinical, preclinical, and discovery phase bioanalytical solutions to top biotech, pharma, and personal care companies.

Bioanalysis

We offer a full breadth of bioanalysis services spanning drug discovery, assay development and validation, and sample analysis to demonstrate proof-of-concept (PoC) or achieve submission-ready data.

Clinical CRO

We transfer validated methods from animal to human matrices during this phase. In addition to bioanalysis, we could provide central lab services such as custom kits and sample management to your clinical sites.

Preclinical CRO

We handle the full breadth of your DMPK and dosage range studies using non-validated methods ahead of lead identification. Afterward, we perform method validation and sample analysis to conduct GLP Tox studies.

Analytical Testing

We offer bioanalytical lab services for chemicals and biologics. Among other techniques, these bioanalytical solutions are provided using LC-MS/MS, ELISA, MSD Quickplex, Luminex Multiplex, Western Blot, and qPCR.

Why Choose NorthEast BioLab for Bioanalysis Services?

At NorthEast BioAnalytical Laboratories, our scientists have 15+ years experience in providing small and large molecule bioanalysis services for clinical, preclinical, and drug discovery studies. We have an excellent track record of advancing Pharmacokinetics (PK), Toxicology (TK), Biomarker Testing, Bioavailability and Bioequivalence (BA/BE), Immunogenicity (ADA), and other custom bioanalytical services. We offer Method Development and Validation using LC-MS/MS, ELISA, MSD ECL, Luminex Multiplex, Western Blot, and qPCR, among other technologies. We are a GLP/GCLP compliant, FDA audited, and DEA & CT State Schedule II-IV approved bioanalysis services facility.

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Our latest study together was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis. This study, same as all other bioanalytical studies with NorthEast BioLab, was completed with very high quality and reporting standard and incredible responsiveness.

We have worked with NorthEast Biolab on several programs and have found them to be professional, collaborative, and responsive. As a small company, our vendors are key members of our project teams. The scientists at NorthEast Biolab are technical experts, who produce high-quality data, on-time, and on-budget.

FAQs: Our Bioanalysis and Bioanalytical Lab Services

Answers to bioanalysis and bioanalytical lab services questions popular among our potential clients.

What is Bioanalysis?

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.

Do you offer small molecule or large molecule bioanalysis?

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.

Do you develop new methods or transfer and validate existing methods for bioanalysis?

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.

How do I estimate the budget for my bioanalysis needs?

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.

What are your typical turnaround times for bioanalytical services?

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.

Do you follow the FDA and ICH guidelines for bioanalytical method validation?

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.

How do you work with third-party providers – CROs, vivariums, other labs, and consultants?

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.