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.

At NorthEast BioLab, we are your one-stop solution for all your PK, ADA, Cytokine, or Cell based assay bioanalytical testing services needs. With over two decades of experience, our highly skilled experts are prepared to tackle any bioanalytical challenge. Here’s why you should choose us:
Consistency and Quality: Our experienced team strictly adheres to rigorous protocols and methods, guaranteeing consistent and reliable results. We have successfully executed 600+ PK, ADA, Cytokine, or Cell based assay bioanalysis, meeting regulatory requirements at every stage. With our robust quality control system, you can trust the accuracy of our data.
Efficiency and Cost-Effectiveness: By partnering with us, you can save time and money. We eliminate the hassle of partnering with multiple labs, managing various contracts and invoices, and shipping samples to different facilities. Our competitive pricing structure, economies of scale, and discounts for multiple assays ensure cost-effectiveness. Additionally, our quick turnaround time keeps your project on schedule.
Innovation and Customization: At NorthEast BioLab, we harness cutting-edge technology and platforms such as LC-MS/MS, ELISA, Meso Scale Discovery, Luminex, QPCR, Digital PCR, and Western Blotting for bioanalysis. Our dedicated research and development team collaborates with you to develop and validate customized methods tailored to your requirements. We possess various instruments capable of handling diverse sample types, matrices, and analytes.
We guarantee exceptional results with our state-of-the-art technology, adherence to industry standards, and unwavering commitment to client satisfaction. Contact us today to discuss your bioanalytical needs.

You can unlock a world of advantages when partnering with a bioanalytical assay lab offering diverse technological expertise, including LC-MS/MS, ELISA, Meso Scale Discovery, Luminex, QPCR, Digital PCR, and Western Blotting. Our lab provides extensive services, from Cell-Based Assays to Immunogenicity Testing and everything in between.
When you work with us, you gain access to an impressive selection of bioanalytical methods and platforms tailored to different types of molecules. Whether you need accurate cellular function analyses, drug concentration measurements, inflammatory marker assessments, or immune response evaluations, we have the industry standard and reliable techniques for your project.
Our skilled lab staff possesses vast experience in bioanalysis and bioanalytical lab services, allowing them to troubleshoot even the most challenging projects confidently. Rest assured, they’ll guide you through every step of the bioanalytical process and deliver high-quality data and results.
Choosing our lab will streamline your workflow and save time and money. In other words, no more juggling multiple labs or managing contracts, invoices, and sample shipments. We offer a hassle-free experience, minimizing the risk of delays, errors, and inconsistencies.
Collaboration is at the heart of what we do. We develop and validate customized and innovative bioanalytical methods based on your needs. Our lab is flexible and creative, ensuring these methods’ robustness, accuracy, and reproducibility to meet regulatory criteria.
Rest assured, our bioanalytical methods and data adhere to the highest standards set by GLP, FDA, and other regulatory agencies. We follow best practices and maintain an excellent quality management system that guarantees data integrity, security, traceability, and accessibility. Our lab has undergone successful audits and inspections, reaffirming our commitment to excellence.
Experience the advantages of working with a bioanalytical assay lab renowned for its broad technological expertise and exceptional service offerings. Partner with us today.

Discover the comprehensive biomarker testing services offered by NorthEast BioLab, a leading contract research laboratory. Our state-of-the-art bioanalytical laboratory specializes in biomarker testing services for various therapeutics, including small molecules, biologics, cell therapies, gene therapies, and novel treatments. With over 20 years of experience in the field, we have the expertise and cutting-edge technology to measure drug pharmacodynamic effects, safety, and efficacy.
Our bioanalysis lab ensures accurate and reliable results with modern analytical platforms like LC-MS/MS, ELISA, Meso Scale Discovery, Luminex, QPCR, Digital PCR, and Western Blotting. Our specialized services include MOA-based pharmacodynamic biomarkers assay and biologically relevant cell-based bioassay, providing valuable mechanistic insights into drug action and disease progression.
In addition to our advanced testing capabilities, we also offer GLP cytokine analysis for cytokine release syndrome (CRS) and fit-for-purpose assays tailored to meet your specific needs and objectives for each study. Rest assured, our bioanalytical services adhere to the regulatory guidelines from the FDA, EMA, and other governing agencies.
Choose NorthEast BioLab for all your biomarker testing needs and experience the industry’s highest quality, precision, and compliance levels. Contact us today to discuss your requirements and leverage our expertise for your next research project.

Working with a combined preclinical/clinical bioanalytical services CRO lab, such as an assay lab or bioanalytical laboratory, offers numerous benefits:
It seamlessly transitions from preclinical to clinical studies, saving time and cost.
It ensures consistency in analytical methods for preclinical and clinical studies, thereby enhancing the reliability of generated data.
It facilitates a streamlined regulatory process by employing the same analytical methods throughout drug development.
It promotes improved communication between the preclinical and clinical teams, fostering better decision-making and increased efficiency in drug development.
Engaging with a contract research laboratory that provides bioanalytical testing services in a GLP-compliant environment significantly enhances the potential for successful outcomes.

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.