BioTools Inc., a life sciences tools company specializing in the characterization of chiral molecules and biologics, is on the Contract Laboratory – The Laboratory Outsourcing Network! With over two decades of innovation, BioTools has set the standard in Good Laboratory Practice (GLP)-compliant analytical services, providing critical molecular structure information essential for pharmaceutical, biotechnology, and academic research.
Operating from its headquarters in Florida, USA, with divisions in the UK and China, BioTools serves top pharmaceutical companies, regulatory agencies like the FDA, academic institutions, and research laboratories worldwide. Their expertise in chirality, higher-order structural analysis, and biopharmaceutical characterization makes them a trusted partner for the latest research and product development.
Specialized Services Offered
Chirality Services
Understanding chirality is crucial in drug development, as different enantiomers can exhibit vastly different biological activities. BioTools specializes in GLP-compliant chirality determination using:
- Absolute Configuration Determination: Leveraging vibrational circular dichroism (VCD) spectroscopy to determine the absolute configuration of chiral molecules, including pharmaceuticals, natural products, cannabinoids, and terpenes.
- Enantiomeric Excess (%EE) Determination: Assessing the purity of chiral compounds to ensure regulatory compliance and drug efficacy.
These services are essential for companies seeking regulatory approvals from global health authorities.
Biologics Characterization
For biologics such as proteins, antibodies, peptides, and nucleic acids, this company provides a range of GLP-compliant testing solutions:
- Quantitative Secondary Structure Analysis: Using Fourier-transform infrared (FTIR), Raman, and Circular Dichroism (CD) spectroscopy to analyze secondary structures of proteins and biologics.
- Higher-Order Structure (HOS) Assessment: Applying Raman Optical Activity (ROA), Raman, and FTIR to evaluate the three-dimensional conformation of biologics, essential for stability and efficacy.
- Stability Studies: Investigating inter- and intra-molecular stability to ensure batch-to-batch consistency and regulatory compliance.
These services help biopharma companies meet FDA, EMA, and ICH regulatory guidelines for biologic drug approvals.
Other Modalities and Applications
Beyond chiral molecules and biologics, BioTools provides expertise in other specialized analytical applications, all performed under GLP and ISO-standardized methodologies:
- Cryopreservation: Identifying and quantifying molecular composition to ensure sample viability post-thawing.
- Cell Media Analysis: Measuring essential components in cell culture media to optimize growth conditions for biologics manufacturing.
- Quality Control of Beauty Products: Hyaluronic acid analysis and other cosmetic ingredient testing to verify product integrity and meet global safety standards.
Instrumentation and Software Solutions
BioTools provides high-end instruments and AI-enhanced software solutions to support regulatory-compliant analytical workflows:
- ChiralIR-2X™: A market-leading VCD instrument for chiral analysis, essential for FDA and USP compliance.
- ChiralRaman-2X™: A Raman/ROA spectrometer for in-depth biomolecular structural analysis.
- PROTA-3S™: An FTIR protein analyzer for comprehensive secondary structure assessments.
- RamTest™: A handheld Raman analyzer for real-time material identification in pharmaceutical and biotech applications.
- ComputeVOA™ and CompareVOA™: Advanced software solutions for computational VCD and ROA spectral analysis, enhancing data interpretation for regulatory submissions.
Why Partner with BioTools for Analytical Testing?
BioTools Inc., is an industry leader in molecular characterization, providing GLP-compliant, ISO-standardized testing services for pharmaceuticals, biologics, cosmetics, and natural products.
By outsourcing testing to BioTools, companies may benefit from their GLP and global regulatory standards compliance, which ensure that all testing meets the highest quality benchmarks. With a team of world-class scientists and AI-powered software solutions, BioTools delivers insightful data interpretation for research and regulatory approvals.
Need high-precision molecular characterization in record time? Submit a free laboratory request today and let BioTools support your analytical needs!
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