Technology
People first, Science forward.
Technology
Bion Clinicals is equipped with the coupled Brand New LC-MS-MS 4500 Series Machines from the world leader AB-Sciex, a leading-edge tool for accurate, sensitive, and reliable analysis in pharmaceutical, clinical, and biomedical research. Our Machines are capable of analysing the molecules from the picogram, nanogram level and endogenous molecules.
Technology
Bion Clinicals is equipped with the coupled Brand New LC-MS-MS 4500 Series Machines from the world leader AB-Sciex, a leading-edge tool for accurate, sensitive, and reliable analysis in pharmaceutical, clinical, and biomedical research. Our Machines are capable of analysing the molecules from the picogram, nanogram level and endogenous molecules.
State-of-the-Art BioAnalytical Facility
To ensure optimal sample integrity and reliable results, our BA department is equipped with purpose-built design:
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Bioanalytical Area with Yellow/ Monochromatic Lights
Our bioanalytical lab is equipped with monochromatic yellow lights to protect light-sensitive molecules, ensuring that the integrity of the samples is maintained throughout the analysis process.
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21CFR Part 11 Compliant Systems
All our systems are 21CFR Part 11 complaint and soft wares are validated.
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Dedicated Cold Storage Area
We have a dedicated cold storage facility, equipped with both -80°C and -20°C storage units. These units are connected to a centralized data logger system, ensuring precise temperature monitoring and compliance with regulatory requirements.
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Allocated Sample Processing Area
Our sample processing area spans over 2,000 square feet, providing ample space for efficient handling and processing of biological samples in a controlled environment.
We specialize in a wide range of services to support every stage of Clinical Development
Our bioanalytical team has a proven successful track record in developing sensitive and reliable methods for analysing new chemical entities (NCEs), hormones, peptides, vitamins, and other critical biomarkers. We take pride in our ability to design and implement methods that meet the rigorous requirements of regulatory agencies while ensuring accurate, reproducible results.
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PK/TK, Pharmacology, Bioequivalence & Bioavailability Studies
We offer comprehensive services for bioequivalence, and bioavailability assessments to support drug development from early discovery through clinical trials and post-marketing.
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ADA, Nab, Biomarker Assays
We provide expert analysis for Anti-Drug Antibodies (ADA), Neutralizing Antibodies (Nab), and biomarker assays, supporting therapeutic development and patient monitoring.
