Advanced Bioanalytical Services Lab CRO Trusted By Biotech Pioneers For Over 20 Years!

Bioanalytical Services entail the assessment of xenobiotics, biotics, and other analytes of interest in various biological matrices. Specifically, these lab services involve the quantitation of biologics, drugs, metabolites, cytokines, biomarkers, nucleic acids, genes, etc, during integral lab experiments related to therapeutic safety and efficacy. Bioanalytical labs play a crucial role in acquiring essential data during drug research and development, given their extensive portfolio of bioanalytical services such as Pharmacokinetics (PK), ADA Assay, Neutralizing Antibody Assay, Cytokine Analysis, Biomarker Assay, and Bioanalytical Assay Validation. Their deep subject matter expertise and technical know-how ensure accurate analysis and reproducible results, making them an indispensable partner for advancing the patient heath-centric mission of new-age biotechnology companies.

All of the Above! We offer a full suite of bioanalytical services in our US-based, state-of-the-art 19,000 sq ft bioanalytical laboratory. Our gene therapy and large molecule bioanalysis encompass customized bioanalytical assay development and fit-for-purpose or GLP method validation utilizing ELISA, Meso Scale Discovery, Real-Time qPCR, Digital dPCR, and Western Blotting platforms. Additionally, our cell-therapy capabilities extend to Neutralizing Antibody Assay, Cytotoxicity Assay, Biochemical Assay, and Mechanism Of Action (MoA) studies.

Our small molecule bioanalysis includes mass spectrometry and HPLC lab with deep expertise in PK PD Analysis, DMPK, ADME Studies, Tox (TK) Study, and Biomarker Assay. Trust our bioanalytical lab with 20+ years track record on 600+ bioanalysis studies to generate reliable and reproducible data for your IND package and NDA submission.

Both! NorthEast BioAnlaytical Laboratory provides comprehensive bioanalytical services covering method development, transfer, and validation. We perform rapid method development by optimizing sample preparation and other bioanalytical assay components as needed for the targeted calibration range and acceptance criteria. Our bioanalytical experts excel in method transfer between labs, personnel, and equipment. If required, we gladly adjust your method for straightforward validation or if the method transfer fails due to incomplete or incorrect information.

Our reliable bioanalytical services ensure reliable and reproducible measurements of your analytes in a given biological matrix. Following FDA/EMA/ICH guidelines, we run full three-day LC-MS/MS or six-day ELISA method validation to evaluate precision and accuracy. Subsequently, our assays examine selectivity, specificity, recovery, carryover, matrix effect, and process stability. Ultimately, we assess long-term storage stability for your therapeutics and biomarkers. Trust our premium bioanalytical lab for efficient and precise analysis of your crucial samples.

NorthEast BioAnalytical Lab is differentiated as the unwavering provider of comprehensive bioanalytical services with over 20 years of expertise and industry leadership. Our distinguished team of seasoned scientists has successfully executed more than 600 studies for Investigational New Drug (IND), New Drug Application (NDA), Biologic License Application (BLA), and Generics Application (ANDA) filings with the US FDA. We possess an astute understanding of the critical significance of budget and timeline, having navigated these challenges ourselves as a fast growing, small business. Speak to our scientists today to explore how our top-notch bioanalytical services can bolster your groundbreaking drug development initiatives.

Generally, we need just four-to-six weeks for most bioanalytical services such as method development and validation following the issuance of purchase order and securing of all assay supplies. Afterward, we need another five-to-ten days for submitting your audited bioanalytical lab report with complete details of method 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 Ligand Binding Assay and Materials (e.g., antigen/antibody pair availability, etc), ii) Mass Spectrometry Method and Materials (e.g., sample preparation, extended run time/duplicate injection, assay with multiple analytes / metabolites, Other Materials – required columns, well plates, and materials etc), and iii) Test article, Formulation, or Control Matrices – large quantities, controlled substances, specific vehicles, exotic species, uncommon matrices, etc

Yes! NorthEast BioLab is registered with and has been successfully 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.