Biotechnology Laboratory Services

Adventitious Agent Testing
Antigen Testing
Antigenicity Assays Testing
Assay Development Testing
Assay Specificity Testing
Bio potency Determination Testing
Bioassay Testing
Bioavailability Studies Testing
Biochemical Markers Testing
Bioequivalence Studies Testing
Biomarker Discovery Testing
Biotechnology Laboratory Testing
Biotechnology-Derived Plant Field Testing
Capillary Electrophoresis (CE) Testing
Cell Bank Authenticity Assay Testing
Cell Banking Testing
Cell Inhibition Testing
Cell Metabolism Testing
Cell Proliferation Testing
Cell Transfection Arrays Testing
Cell-based Assay Testing
Cellular Expression Testing
Chemiluminescence Assays Testing
Chromogenic Endpoint Activity Testing
Circular Dichroism (CD) Spectroscopy Testing
Co-cultivation Assay Testing
Custom Cell Culture Testing
Differential Protein Expression Profiling Differential Scanning Calorimetry (DSC) Testing
Direct Sequencing DNA Isolation Testing
DNA Transfection Testing
Dot Blot Testing
Drug Interaction Studies Testing
Electrospray Mass Spectrometry (ES-MS) Testing
Enzyme Induction Testing
Extinction Coefficient Determination Testing
Flow Cytometry Testing
Fluorescence Assays Testing
Fluorescence Spectroscopy Testing
Gel Imaging Gene Expression Testing
Gene Therapy Vector Bio distribution Studies Testing
Genetically Modified Organism Design Testing
Genetically Modified Organism Development Testing
High-Resolution Restriction Mapping ICAT Relative Quantitation Testing
Immunoassays Testing
Immunochemistry Testing
Immunoprecipitation Testing
In situ Hybridization Testing
Insertional Mutation Screening Isoelectric focusing (IEF) Testing
Isoenzyme Analysis Testing
Isothermal Titration Calorimetry (ITC) Testing
Isotope Coded Affinity Tagging (ICAT) Testing
Karyological Analysis Testing
Liver Enzyme Assays Testing
MALDI MS Testing
MALDI-ToF Mass Spectrometry Testing
Mechanisms of Internalization Testing
Method Development Method Validation Microarray Chip Printing Molecular Cloning Testing
Molecular Labeling Testing
Mouse Antibody Production (MAP) Assay Testing
N-terminal Sequencing Nano flow RP-HPLC MS/MS Nano spray MS Testing
Peptide Mapping Testing
PERT Assay Testing
Pharmacokinetics Testing
Probe Labeling Probe Labeling Testing
Protein Binding Studies Protein Binding Testing
Protein Characterization Testing
Protein Labeling Protein Labeling Testing
Protein Purification Testing
Protein Stability Testing
Protein Turnover Testing
Radiolabelling Radiolabelling Testing
Receptor Binding and Activation Testing
Receptor Binding Testing
Receptor Mediated Response Assay Testing
RNA Analysis Testing
SDS-PAGE Electrophoresis Testing
SDS-PAGE Testing
Slot Blot Hybridization Testing
Stem Cell Differentiation Testing
Stem Cell Research Testing
Subcellular Localization Testing
Tissue Analysis Testing
Tissue Cross Reactivity Testing
Tissue Cross-Reactivity Testing
Transcription Factor Binding Analysis Transcription Factor Binding Analysis Testing
Transient and Stable Transfection Testing
Trypsin Digestion Trypsin Digestion Testing
Two Dimensional Gel Electrophoresis Two Dimensional Gel Electrophoresis Testing
Viral Clearance Testing
Western Blot Testing

Type of Biotechnology Products

Contract Laboratory can assist your company, academic institution, government agency or organization in outsourcing contract laboratories to perform testing, analysis, and product development for many Biotechnology finished products, processes, systems, in-process materials, raw materials and components such as:

life sciences
aquaculture
forestry
environmental
pharmaceuticals
agriculture
medical devices
biopharmaceuticals
food and beverages
nutraceuticals
biological materials
in vitro and in vivo cell cultural media
biological matrices
vaccines
therapeutic agents
recombinant proteins
gene therapy products
biomolecules
blood products
grains
plants
vegetables
fruits
clotting factors
plasma fractionations
human tissues (bone
skin
corneas
ligaments
tendons
spinal fluid
dura mater
oocytes
semen)
toxic materials
infectious materials
cellular material
xenotransplantation products
animal tissues
plasma
blood derivatives
red blood cells
white blood cells
allergenics
stem cells
human cells
cellular/gene therapy
novel antibodies
biopharmaceuticals
macromolecules
polypeptides
proteins
oligonucleotides
aptamers
oligodeoxynucleotides
small molecules
medical diagnostic equipment
bioassays

• ISO 7886 - Sterile hypodermic syringes for single use
• ASTM F2103 - Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
• USP 129 - UAnalytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
• ANSI 0001.1-2015 - Standardization of in vitro Assays to Determine Anthrax Toxin Activities
• ASTM F665-09(2015) - Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
• ASTM F719-81(2012) - Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
• ASTM F895-11(2016) - Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
• ISO 20399 - Biotechnology - Ancillary materials present during the production of cellular therapeutic products - Part 2: Best practice guidance for ancillary material suppliers
• BS 1619 - Biotechnology. Large-scale process and production. General requirements for management and organization for strain conservation procedures.
• ISO 21899 - Biotechnology - Biobanking - General requirements for the validation and verification of processing methods for biological material in biobanks
• ASTM F2739 - Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
• ASTM F2450 - Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
• ASTM F3259 - Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
• ISO 20391 - Biotechnology - Cell counting - Part 1: General guidance on cell counting methods
• ISO 20395 - Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR
• ISO 20399 - Biotechnology - Ancillary materials present during the production of cellular therapeutic products - Part 1: General requirements
• ISO 20688 - Biotechnology - Nucleic acid synthesis - Part 1: Requirements for the production and quality control of synthesized oligonucleotides
• ISO 21709 - Biotechnology - Biobanking - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
• ISO 21899 - Biotechnology - Biobanking - General requirements for the validation and verification of processing methods for biological material in biobanks
• ISO 22442 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
• ASTM E3256-20 - Standard Practice for Reference Scenarios When Evaluating the Relative Sustainability of Bioproducts
• ASTM E3066-20 - Standard Practice for Evaluating Relative Sustainability Involving Energy or Chemicals from Biomass
• ASTM F3142-16 - Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs
• ASTM F3209 - 16 - Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy
• ASTM F2315-18 - Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
• ASTM F2884-12 - Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion
• ASTM E1262-88(2018) - Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
• ASTM F3106-14 - Standard Guide for in vitro Osteoblast Differentiation Assays
• ASTM F2952-14 - Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
• ASTM F1984-99(2018) - Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
• ASTM F2259-10(2012)e1 - Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
• ASTM F2064-17 - Standard Guide For Characterization And Testing Of Alginates As Starting Materials Intended For Use In Biomedical And Tissue Engineered Medical Product Applications
• ASTM F2103-18 - Standard Guide For Characterization And Testing Of Chitosan Salts As Starting Materials Intended For Use In Biomedical And Tissue-Engineered Medical Product Applications
• ASTM F2131-02(2012) - Standard Test Method For In Vitro Biological Activity Of Recombinant Human Bone Morphogenetic Protein-2 (RhBMP-2) Using The W-20 Mouse Stromal Cell Line
• ASTM F2212-19 - Standard Guide For Characterization Of Type I Collagen As Starting Material For Surgical Implants And Substrates For Tissue Engineered Medical Products (TEMPs)
• ASTM F2260-18 - Standard Test Method For Determining Degree Of Deacetylation In Chitosan Salts By Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
• ASTM F2605-16 - Standard Test Method For Determining The Molar Mass Of Sodium Alginate By Size Exclusion Chromatography With Multi-Angle Light Scattering Detection (SEC-MALS)
• ASTM F2998-14 - Guide For Using Fluorescence Microscopy To Quantify The Spread Area Of Fixed Cells
• ASTM F2903-11 - Standard Guide For Tissue Engineered Medical Products (TEMPs) For Reinforcement Of Tendon And Ligament Surgical Repair
• ASTM F3294-18 - Standard Guide For Performing Quantitative Fluorescence Intensity Measurements In Cell-Based Assays With Widefield Epifluorescence Microscopy
• ASTM F3223-17 - Standard Guide For Characterization And Assessment Of Tissue Engineered Medical Products (TEMPs) For Knee Meniscus Surgical Repair And/Or Reconstruction
• ASTM F3163-16 - Standard Guide For Classification Of Cellular And/Or Tissue-Based Products (CTPs) For Skin Wounds
• ASTM F3089-14 - Standard Guide For Characterization And Standardization Of Polymerizable Collagen-Based Products And Associated Collagen-Cell Interactions
• ASTM F2903-11 - Standard Guide For Tissue Engineered Medical Products (TEMPs) For Reinforcement Of Tendon And Ligament Surgical Repair
• ASTM E1564-00(2019) - Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
• ISO 21709 - BIOTECHNOLOGY - BIOBANKING - PROCESS AND QUALITY REQUIREMENTS FOR ESTABLISHMENT, MAINTENANCE AND CHARACTERIZATION OF MAMMALIAN CELL LINES - AMENDMENT 1