Bioanalytical discovery studies including in-vitro and in-vivo compound screening, lead optimization, and dose range finding...
15+ Years’ experience in methods to quantitate drugs and metabolites in biological fluids...
Partner with our clients throughout the drug development process for high-quality, on-time regulatory submission...
Our veteran scientific team develops and fine-tunes research-grade assays (RGAs) to balance predefined analysis quality with quick data turnaround. We have extensive experience in analyzing routine matrices such as blood, serum, plasma and urine, and non-routine matrices such as various tissues, cerebrospinal fluid (CSF) etc. We add substantial value by driving a clear strategic focus through the risk-benefit of “fit-for-purpose”.
Our meticulous scientists develop, validate, and optimize bioanalytical methods to carefully determine drug and metabolite concentrations in plasma, serum, and urine. We are adept at running PK/TK and other similar analysis using HPLC and LC/MS/MS systems. Our “Clients First” philosophy propagates existential vendor collaboration as an investment that helps us learn, stay grounded and be nimble.
Our projects typically start at the pre-clinical phase and carry forward into the clinical phase, given the depth of our services and expertise. Clients benefit from our robust bioanalytical methods and data management. Adjacently, we have a spotless history of clinical sample management and kit assembly.Over the past few years, we have provided sample kits to a large number of studies worldwide.
Systematically accelerate and focus your priorities.
NorthEast BioLab ’sclient-centric approach creates lasting partnerships that help overcome challenges and advance together towards bringing new drugs to market. Our experience in helping multiple clients along a similar pathway translates into accomplishing all this with attractive resource and cost efficiencies for you. Furthermore, our collaborative mind-set enables working in unison with your internal team and other vendors towards our shared common goals.
Expect collaborative onboarding, rollout, and delivery.
We are committed to 100% process transparency with all our clients. We inculcate collaboration through disintermediated and ongoing communication of clients with our frontline lab analysts and managers. We understand the dynamic and evolving nature of our work and balance the scales in your favor through our promise of enhanced flexibility and quick turnaround. That said, we have uncompromising scientific ethics and dedication to high quality facilitated by our staff’s integrity, passion, teamwork, and our continually evolving Quality Systems.
Navigate your drug candidates to the clinical phase.
The success of your drug development program is our primary focus. We will help you with target identification and validation, assay development, lead optimization, preclinical development, all the way into clinical trials and market. Our integrated bioanalytical services are designed to optimize your cost and resources, leveraging our scientific expertise, operational excellence and latest knowledge of the regulatory environment.
We firmly believe in treating our customers with utmost respect, and take full responsibility and ownership of delivering flawlessly on our promises. We achieve this by fostering a deep sense of care among our employees for what our clients are trying to accomplish. “Say what we mean, and mean what we say.”
We are a positive and optimistic enterprise that’s intrinsically motivated to contribute disproportionately higher towards fighting life-limiting diseases, such as cancer. We aim to fulfill this commitment towards our very own families and the broader humanity by helping discover the right treatment.
Ultimately, we are driven by our employees’ intellectual curiosity. The inner scientist in each of our analytical chemists is constantly fueled by daily successes / failures during experimentation. Our emphasis on the need to become practice area experts helps ignite innovation.
Collectively, we look at our size positively as compared to multi-billion dollar CROs out there. We pride ourselves on our ability to be nimble and offer clients a tailor-made experience.
“Building a new kind of drug development and research company – created in, of and for the 21st century…”
“Finding fulfillment in the never-ending pursuit of putting good science to work for all…”
“Working with great teams to help find cure for the most menacing diseases of our generation…”
“I’m driven to build lasting and rewarding partnerships to bring more joy to our customers’ and employees’ lives…”
Our laboratory teams stay abreast with the latest regulatory requirements, guidance, and industry expectations. We continually optimize study workflows to maximize efficiency with desired compliance.
Our scientists fully validate bioanalytical methods for your studies and thoroughly assess analyte stability. Sample integrity is the most important aspect of the process and we monitor full chain of custody for sample storage conditions. We conduct end-to-end experimentation and report summary results according to our Standard Operating Procedures (SOPs). Our dedicated Quality Assurance Unit carefully ensures strict compliance with the SOPs and regulatory requirements.
Our audit history with regulatory authorities and client inspections is spotless, with the most recent FDA audit completed successfully as early as 2016. All our employees are routinely trained in regulatory compliance (FDA: GLP, GCP), safety (CDC, OSHA), waste management (EPA), patient privacy (HIPAA), HR focused policies, and additional areas as needed.
In our experience, this continual emphasis on the highest quality translates to reliable and reproducible bioanalytical data for our clients.
Sample preparation and liquid chromatography are sometimes ignored during method development and validation given the highly selective Multiple Reaction Monitoring (MRM) in LC – MS analysis. For a rugged method, however, we must pay attention to all sample cleanup and chromatography steps. Additionally, this approach safeguards reliability and minimizes tweaking while transitioning from study-to-study all the way up to clinical development.
Mostly, only limited information on ...
Bioanalytical assays are widely used to quantify drugs and their metabolites in a variety of biological matrices. Incurred sample reanalysis (ISR) has steadily gained popularity as a quality assessment tool for bioanalytical assays. ISR is repeated measurement of analyte within a selected sample set from dosed subjects in separate runs on different days to establish result reproducibility.
Method validation in pharmacokinetic and bioanalytical studies ensures high ...
Dried blood spot (DBS) analysis has been practiced for ~100 years, but has started gaining traction as an alternate to traditional assays only this decade. Human / Animal blood is spotted on prepared filter cards, the cards are air dried, stored in airtight bags, and shipped under administered humidity and temperature levels. For bioanalytical analysis, we punch tiny discs out of ...
Matrix Effects are the suppressing or enhancing properties of a co-eluting compound from a biological matrix on the primary signal response of the target analyte. In several liquid chromatography-tandem mass spectrometry (LC-MS) biological studies, Matrix Effects can suppress the ion intensity by interfering with target analyte ionization. Compounds with high mass, polarity, and basicity are typical candidates to trigger matrix effects.
Matrix components can deprotonate and ...
In an ideal scenario, a typical solution that is equally injected and then tested multiple times should have same signal response. In practice, however, the signal will likely vary due to different analytical conditions. These conditions include inconsistency in sample preparation, injection volume, mass spectrometer, and matrix effects. Hence, it is necessary to include an Internal Standard (IS) for analysis. Scientists define Internal standards as known ...
It’s no secret that scientific research laboratories around the world aren’t exactly the most eco-friendly institutions. High energy utilization, single use products, and continuous chemical consumption are among the many routine ways a laboratory can hurt the environment. However, we can proactively address improper laboratory practices to lessen their adverse impact on the environment.
Ultra-low temperature (ULT) freezers are one of the biggest culprits for energy ...
New Haven, CT, Aug 01, 2018 – NorthEast BioLab, a boutique bioanalytical services contract research organization (CRO), today announced expansion of their laboratory facilities.
“We are committed to investing in technology and infrastructure that will strengthen our value proposition. NorthEast BioLab is expanding its facilities to efficiency fulfill our rising service demand”, commented Dr. Vipin Agarwal, President & CEO of NorthEast BioLab. These additions expand upon the ...
New Haven, CT, Aug 01, 2018 – NorthEast BioLab, a boutique bioanalytical services contract research organization (CRO), today announced Abhay Pandey as their VP of Business and Corporate Development.
Mr. Pandey will be responsible for crafting and executing the Company’s sales and marketing, capital expenditure, as well as financing strategy. Dr. Vipin Agarwal, President and Chief Executive Officer of NorthEast BioLab, commented, “We are pleased that ...
The projects ranged from method validation and stability studies, cross-validation of other external labs, support for investigator sponsored studies, Clinical Phase I to Phase IV studies (including pivotal BE studies). Our last major study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers were to be analyzed within a very short time frame. This study – and all other studies – were done according to a very high quality and reporting standard and with a high responsiveness. We have audited the Lab in 2004 by our BHC GLP QAU and in 2006 by a BHC GLP trained bioanalytical expert, in both cases without major findings.
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. They also provided critical insight into data analysis, and are compliant with industry best practices and regulatory standards. We would certainly recommend NothEast Biolab and look forward to working with them in the future.
I have worked with a number of companies (large and small) over the years and NorthEast Biolab is by far the most responsive and thorough service provider. In an industry where a vast majority of businesses establish practices that remain rigid, NorthEast Biolab works closely with the client to provide the most efficient and cost-effective approach to getting the job done. The integrity of the scientific staff is as refreshing as their willingness to provide ingenious scientific input and high-quality data. They truly go that extra mile to make the collaborations successful and I will continue to enjoy very productive interactions with them in the future.