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Nelson Labs (Sotera Health Company)
Nelson Labs (Sotera Health Company) is listed as a large business research supplier in the Scientist.com network, with 5 sites in 2 countries.
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Services
What this research supplier says it provides, as listed in the Scientist.com network.
Type of company: Large business
Biomarkers
- Antimicrobial Effectiveness Testing Measure the efficacy of anti-microbial preservatives added to a product.
- Antioxidant Assays Use biochemical, cell-based or in vivo assays to measure total antioxidant capacity.
- Hematoxylin & Eosin (H&E) Staining Visualize microscopic structures in cells or tissues.
Cell Culture and Characterization
- Adherent Cell Culture Grow monolayers of anchorage-dependent cells.
- Bacterial Cell Culture Culture and Grow bacterial cells.
- Cell Culture Culture primary or immortalized cell lines.
- Histology Examine by microscopy the anatomy of cells and tissues of clinical patients and animal models.
- Yeast Cell Culture Grow yeast strains or species.
Chemical and Compound Analysis
- API Physical Characteristics Characterize physical and chemical properties of new drug molecules to develop safe, effective, and stable dosage forms.
- Atomic Absorption Analysis Measure the elemental composition of a diverse array of samples.
- Chemical Stability Measure the stability of small molecules in solution.
- Compound Integrity Analyze the identity and purity of small molecule drug candidates.
- Dissolution Profiling Measure release of API from formulation (tablet or capsules) under GMP guidelines.
- Electrophoresis Separate nucleic acids or proteins based on physical properties such as charge or mass.
Show all 21 in Chemical and Compound Analysis
- Elemental Impurity Analysis Identify and evaluate the presence of heavy metals in pharmaceuticals.
- Endotoxin Testing Use standard assays like LAL (Limulus Amebocyte Lysate), rFC (Recombinant Factor C), or MAT (Monocyte Activation Test) to detect and quantify the level of endotoxins in a sample
- Excipient Compatibility Test excipients for drug formulation, effects of temperature, time, humidity, pH and light exposure as well as excipient release.
- Headspace Gas Chromatography Analyze volatile organic compounds (VOCs) partitioned above the liquid/solid phase of a sample.
- Heavy Metals Analysis Ensure trace levels of heavy metals are below the maximum allowable limits for consumer safety.
- Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) Analysis Detect metals and several non-metals at concentrations as low as one part in 1015 (part per quadrillion, ppq) on non-interfered low-background isotopes.
- Liquid Chromatography Separate substances using a mobile and stationary phase.
- Melting Point Use melting point analysis to characterize compounds based on calorimetry and thermodynamic data.
- Optical Rotation Distinguish between optical isomers as well as between natural versus man-made compounds.
- Particle Size Analysis Measure particle size distribution and characterize particle size, porosity and composition.
- Photostability Measure drug degradation rates after exposure to various light sources.
- Process Residual Impurities Detection Measure trace levels of impurities.
- Protein Separation and Detection Separate proteins based on properties such as solubility, adsorption or size differences.
- Secondary Ion Mass Spectrometry Detect trace level impurities and obtain elemental or molecular chemical data for solid sample surfaces.
- Solubility Studies Analyze substances for kinetics of solubility using nephelometry and UV-Vis spectrometry.
Show all 115 services
Chemical and Compound Testing
- Bacterial Water Analysis Analyzing water samples to identify the bacteria present.
- Limulus Amebocyte Lysate (LAL) Test Detect bacterial endotoxins in raw materials used for the production of cosmetics products.
- Puncture Strength Testing Use compressive tests to determine the rupture properties of a material.
- USP <2021> Microbial Enumeration Tests Estimate the total aerobic microbial count, total combined yeast and mold counts, and the presence of bile-tolerant gram-negative bacteria present in nutritional supplements.
- USP <2022> Microbiological Procedures for Absence of Specified Microorganisms Determine the absence of objectionable organisms in nutritional supplements.
- USP <85> Bacterial Endotoxin Test Test to detect or quantify bacterial endotoxins that may be present in or on a sample.
Chemistry, Manufacturing and Controls (CMC)
- API and Drug Product Stability Testing API and Drug Product Stability Testing.
- API and drug product storage and release API and drug product storage and release
- API Stress Testing Studies Develop analytical methods to predict stability problems and identify degradation products/pathways under forced degradation conditions.
- API/ Excipients Compatibility Studies Delineate real and possible interactions between potential formulation excipients and the API as an important risk reduction exercise early in formulation development.
- API/DP specific test methods API/DP specific test methods (e.g., stability indicating HPLC assay and purity)
- Chemistry, Manufacturing and Controls (CMC) Request Chemistry, Manufacturing and Controls services
Show all 11 in Chemistry, Manufacturing and Controls (CMC)
- Compendial test methods Run Compendial test methods (e.g., KF)
- Drug Product Stability Use accelerated stress conditions to determine degradation pathways and identify manufacturing issues.
- Forced Degradation Run light, heat, humidity, acid hydrolysis and oxidation tests to evaluate substance degradation.
- ICH-compliant stability testing Perform ICH-compliant stability testing
- Thermo Scientific iCAP Q ICP-MS Expand your analytical capabilities with this complete trace elemental analysis solution for your high-throughput lab.
Clinical Consulting
- Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.
Discovery Chemistry
- Extractable and Leachable Assessment Quantify potential impurities from container closures & packaging.
- Impurity Synthesis Use high resolution MS or NMR to eliminate intermediates or organic byproducts and determine impurity content.
- LCMS Analysis Physically separate substances using liquid chromatography and mass spectrometry.
- Leachable and extractable testing Leachable and extractable testing
- Leaching and Aged Leaching Assess the leaching potential of products with studies that follow the formation and movement of metabolites or show restricted leaching under simulated use conditions.
- Method Development and Validation Develop and validate methods for synthesis and scale up of drug candidates.
Show all 7 in Discovery Chemistry
- UV and IR Profiling Analyze the integrity of a compound or large biomolecule.
Effectiveness
- Minimum Bactericidal Concentration (MBC) Test Assess the bactericidal activity of a test compound.
Farm & Livestock Solutions
- Virology Virus isolation for identification of new and emerging viruses.
Food Safety & Regulations
- Anaerobic Plate Count Determine the total anaerobic bacteria present in a food or contact-surface sample.
- Clostridium perfringens Tests Ensure food and water safety by detecting the presence of C. perfringens, its spores or the toxins in samples.
- E.coli 0157 Tests Isolate and identify the presence of a distinct variant of the E.coli species or its potent toxin in food, water or contact-surface samples.
- E.coli spp. Testing Use molecular, immunological or cultured methods to detect the presence of E.Coli species in samplings from food, water, contact surfaces or another source.
- Free Coagulase Test Use a tube test to determine whether or not the S.aureus species is present in Staphylococcus isolates from a sample.
- Listeria monocytogenes Tests Assess product samples or the direct contact surfaces for a specific and prevalent Listeria species capable of growth at low temperatures.
Show all 14 in Food Safety & Regulations
- Listeria spp. Testing Use molecular, immunological or cultured methods to identify potential growth sites for all species of the Listeria genus.
- Norovirus spp. Testing Use molecular, immunological or microscopic methods to detect and quantify Norovirus species in food, water or contact-surface samples.
- Pseudomonas aeruginosa Testing Use molecular, immunological or cultured methods to confirm the presence or absence of P.aeruginosa in samples from food, water or processing surfaces.
- Pseudomonas spp. Testing Detect the presence and abundance of various cold-tolerant Pseudomonas species that cause or contribute to spoilage in meat, poultry, seafood, dairy or beverages.
- Salmonella spp. Testing Use molecular, immunological or cultured methods to identify the presence of Salmonella species in food or contact-surface samples.
- Shigella spp. Testing Use molecular, immunological or cultured methods to detect various species of Shigella in food samples.
- Total Coliform Testing Measure the bacterial content of a sample to assess food safety, efficacy of sanitation methods or handling practices.
- Total Viable Count (TVC) Estimate the total living microbial populations present in a food or beverage sample to guarantee product quality.
General in vivo Toxicology
- Carcinogenicity Study - Mouse Conduct a repeat dose, chronic carcinogenicity study in mice to determine the tendency of your compound to produce tumors.
- General Toxicology Use in vivo models to assess acute and sub-acute toxicity as well as chronic and sub-chronic toxicity.
In Vitro Assays
- Antivirals Measure anti-viral activity in biochemical and cell assays.
- Assay Development Construct or create new assays or modify existing ones.
- HTS Assay Development Develop assays to use in high throughput screening.
- In Vitro Assay Development Develop innovative assay and screening methods outside a living organism to enable a wide range of pre-clinical activities.
- Viral Clearance Assays Measure the capacity to remove or inactivate infectious agents during the manufacturing process.
In Vitro Pharmacology
- Target Identification Identify the target(s) of a biologically active substance.
In Vitro Toxicology
- Cytotoxicity Test for effects on cell viability and proliferation
- Cytotoxicity Testing Determine whether a cosmetic product or ingredient is toxic to in vitro cell cultures.
Other Specialty Toxicology
- Microbial Testing Test samples for microorganisms, identify species, do bioburden analysis and measure endotoxin levels (LAL).
- Raw Materials Testing Verify that raw materials are sterile and not contaminated by mycoplasma, virus or other microorganisms.
- United States Pharmacopeia (USP) Testing Use USP standards to ensure quality of pharmaceuticals, supplements and food ingredients.
- Viral Testing Characterize viral products for functional activity and possible contamination.
Pharmacovigilance
- GxP Compliance Monitoring Ensure products or services adhere to a set minimum standard.
Protein Sciences
- Carbohydrate Isolation Protocol Development Design and optimize protocols for carbohydrate isolation.
- ELISA Detect the presence of antigens recognized by antibodies or find antibodies that recognize an antigen.
- Protein Purification Isolate native or recombinant proteins from a sample.
- Virus Production Produce high titer viruses, viral expression vectors and vaccines.
- Western Blots Detect specific proteins in a sample of tissue homogenate or extract.
Raw Materials
- Antimicrobial Active Ingredients Acquire antimicrobial active ingredients for making consumer healthcare products.
REACH Services
- OECD 406: Skin Sensitisation This method provides information on health hazard likely to arise from exposure to test substance via intradermical injection and/or epidermical application.
- OECD 412: Subacute Inhalation Toxicity: 28-Day Study This revised Test Guideline 412 (TG 412) has been designed to fully characterize test article toxicity by the inhalation route following repeated exposure for a limited period of time (28 days), and to provide data...
- OECD 413: Subchronic Inhalation Toxicity: 90-day Study This revised Test Guideline 413 (TG 413) has been designed to fully characterize test article toxicity by the inhalation route following repeated exposure for a period of 90 days, and to provide data for quantitative...
- OECD 451: Carcinogenicity Studies The objective of a long-term carcinogenicity study is to observe test animals for a major portion of their life span for the development of neoplastic lesions during or after exposure to various doses of a test...
- OECD 452: Chronic Toxicity Studies Evaluate the direct and indirect impact of prolonged and repeated toxin exposure to test organisms.
- OECD 471: Bacterial Reverse Mutation Test (Ames) Measure the mutagenic potential of test compounds.
Specialty Dosing Routes
- Single Dose Acute Inhalation Study - Other Species Conduct a single dose inhalation study in other species to determine the toxicokinetic behavior of your compound.
Testing Services
- Accelerated Stability Determine shelf life of drug formulations by comparing API breakdown at elevated temperature.
- ASTM E2315: Time-Kill Procedure (Antimicrobial Testing Study) Assessment of Antimicrobial Activity Using a Time-Kill Procedure
- Bacterial Identification Testing Use biochemical and molecular methods to identify unknown microorganisms.
- Characteristic Testing Characterization of physical and chemical properties of raw materials
- CLSI M26-A: Minimum Bactericidal Concentration (MBC) Determine the lowest concentration of an antimicrobial agent that is lethal to the target bacteria in vitro.
- Cosmetic Preservative Efficacy Test Assess the efficacy of a product's preservative system.
Show all 17 in Testing Services
- Cosmetics Aerobic Plate Count Determine the level of aerobic bacteria present in a cosmetic or personal care product.
- Cosmetics Yeast and Mold Count Determine the presence of fungi in a cosmetic or personal care product.
- Freeze-Thaw Testing Use freeze-thaw cycling to measure the long-term durability of cosumer products.
- In Vitro Toxicology Testing Non-animal testing employing US and international methodologies for determining irritation and other undesirable potentials.
- Microbiological Sterility Testing Test the presence of viable microorganisms.
- OECD 439: Skin Irritation Test (SIT) Reconstructed Human Epidermis Test (RhE) Method - An in vitro testing method designed to identify chemicals and/or mixtures capable of inducing moderate skin irritation.
- Package Compatibility Tests Ensure that the consumer product is not adversely affected by the package components and vice versa.
- Raw Material Microbiological Testing Examples of which include Microbial Content using USP <61> and <62> and other standards, LAL Endotoxin, Ames Mutagenicity and Sterility.
- Real-time Stability Test Assure stability and physical integrity of consumer products in real-time conditions.
- USP <61> Microbial Limits Test Determine whether a substance or preparation complies with an established specification for microbiological quality.
- USP <62> Microbial Limits Test Determine the presence or absence of specific microorganisms.
- Website
- www.nelsonlabs.com
Where it operates
Sites by country, with the cities in each.
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United States 4 sites
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Belgium 1 site
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