Saturday, October 1, 2022

NorthEast Bioanalytical Laboratory: Critical Application and Impact

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Arslan Shah
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Let us first understand what is the drug development process? The primary aim of the drug development process is to identify potent molecules that can safely and effectively treat diseases. Having a bioanalytical CRO offering solutions at every stage of drug development is crucial for the success of a drug development project. As the need for novel drug product increases, bioanalytical lab services helping sponsors bring safe and effective drugs become of utmost importance. NorthEast bioanalytical laboratory is one such robust partner, helping sponsors achieve their drug development goals.

For more than 15 years, NorthEast bioanalytical laboratory has been providing services for quantifying drugs and their metabolites, biomarkers, and clinical trial kitting. They have a track record of providing rapid and high-quality results in GLP studies, drug development, and clinical bioanalytical services. Hence, sponsors can rely on their expertise to accomplish drug development timelines. Following is an overview of the company.

  • A mission-driven CRO aiming to achieve all potential drug development goals
  • A robust roster of 500+ preclinical and clinical studies, where data has been successfully submitted for Investigational New Drug, Generics Applications, New Drug Application, and Biologic License Applications fillings
  • Deep expertise in Toxicokinetic and pharmacokinetic studies through traditional ELISA assays and LC-MS/MS systems
  • Besides, services include immunogenicity testing, biomarker validation, cell-based assays, biochemical assay, cytotoxicity assay, and mechanism of action studies
  • Notably, the entire facility is FDA audited, GLP and GCP compliant, and DEA Schedule II-V approved for generics, pharma, biologics, and vaccine studies.

The current article highlights the impact of NorthEast bioanalytical laboratories and their clinical applications.

NorthEast bioanalytical laboratory

The scientists at NorthEast bioanalytical laboratory have significant experience working in all major therapeutic areas. The scientists are pioneers in bioanalytical services method development and validation. Moreover, they can analyze drug and drug metabolites in several biological matrices irrespective of the therapeutic area. Besides, they are heavily focused on oncology studies to meet rising sponsor demands for cancer research. Scientists at NorthEast laboratory believe oncology research will have increased demand shortly. Hence, they have strategically aligned themselves to offer higher R&D productivity to provide efficient and innovative solutions for oncology research.

Nevertheless, their focus on oncology has allowed them to work and develop several cancer-related drugs and proprietary systems. In addition, they are confident in developing and validating analytical methods within 4-8 weeks in oncology research.

NorthEast bioanalytical laboratory is dedicated to growing its infrastructure and technology to surpass the demands of clients and sponsors. They have an 8000+ sq. ft facility with room for additional expansion. They have a plethora of HPLC with TotalChrom systems and LC-MS/MS with Analyst for collecting, processing, and reporting data. Their LC-MS/MS systems have micro HPLC gradient units and dual column capability. Besides, all HPLC systems are fitted with fluorometric and ultraviolet detection units. Other laboratory equipment include Bio-Rad Bio-Plex systems, Luminometers, SpectraMax plate readers, Fluorescence plate readers, and BioTek plate washers. Not to mention, bioanalytical equipment is routinely maintained and thoughtfully designed. Also, the entire facility is 24*7 monitored with backup generators and secure IT systems.

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