Programs use many different analytical techniques to provide information on differences in Biosimilar pharmaceuticals to an original product. This analysis compares features and can show where changes need to be made before the product can be advanced. It can also confirm the Biosimilarity.
Biosimilars are also known as 'follow on biologics' and are tested for similarity to an original. The analysis looks at biological, structural and chemical attributes. After the biosimilar testing and confirmation products are then tested with clinical trials and further forms of testing.
Biologics Laboratory Testing and Scientific Research:
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Biologics Testing and Research Services
Contract Laboratory can help you with all your Biologics testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:
Purity Testing
Biological Reactivity Testing
Agar Diffusion Testing
Polymerase Chain Reaction PCR Testing
Mass Spectrometry Testing
Chromatographic Testing
Immunochemistry Testing
Functional Assays Testing
Analytical Comparability Testing
Flow Cytometry Testing
Peptide Mapping Testing
Genomic DNA Testing
Functionality Testing
Extractables Testing
Biocompatibility Testing
Microbiology Testing
Heterotrophic (Standard) Plate Count Testing
Decontamination Effectiveness Testing
Particle Measurement Testing
Endotoxins Testing
Dynamic Flow Imaging Testing
Cytotoxicity Testing
Mycoplasma Testing
Type of Biologics 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 Biologics finished products, processes, systems, in-process materials, raw materials and components such as:
Combination Products
Human Cells
Tissues
and Cellular and Tissue-Based Products (HCT/P's)
Blood
Blood Components
Cord Blood
Biosimilars
Biopharmaceuticals
Recombinant Therapeutic Proteins
Therapeutic Peptides
Allergenics
Allergen Extracts
Allergen Patch Tests
Antigen Skin Test
Cellular Products
Gene Therapy Products
Gene-based Treatments
Cell-based Treatments
Cloning Products
Tissues
Tissue Products
Bone
Skin
Corneas
Ligaments
Tendons
Stem Cells
Sperm
Semen
Oocytes
Heart Valves
Adult Vaccines
Pediatric Vaccines
Xenotransplantation
Transplantation of Non-Human Cells
Tissues or Organs Into a Human
Injectable Allergen Extracts
Sublingual Allergen Extract Tablets
Dura Mater
Hematopoietic Stem
Progenitor Cells
Fascia
Ocular Tissue
Skin
Vascular Grafts
Amniotic Membranes
Allografts
Hematopoietic Stem Cells
Embryos
Cultured Nerve Cells
Lymphocyte Immune Therapy
Collagen
Femoral Veins
Demineralized Bone
Tendon Allografts
Bone Allografts
Fibroblasts
Keratinocytes
Bone Marrow
Erythropoietin
Coagulation Factors
Heparin
Insulin
Interferon Beta
Monoclonal Antibodies
Growth Factors
Cytokines
Fetal Bovine Serum
Viral Vaccines
Bacterial Vaccines
Tissue Engineered Medical Products
Bioaerosols
Biomaterials
Recombiant Proteins
Biologics Test Methods and Standards
Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Biologics test methods,standards, procedures or specifications.
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
ANSI ASN-0002: - Authentication of Human Cell Lines: Standardization of STR Profiling
ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
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
AS 4760 - Procedure for specimen collection and the detection and quantification of drugs in oral fluid
ASTM F1830 - Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps
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 F2529 - Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
ASTM F2888 - Standard Practice for Platelet Leukocyte Count-An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
ISO 20391 - Biotechnology - Cell counting - Part 1: General guidance on cell counting methods
ISO 20399 - Biotechnology - Ancillary materials present during the production of cellular therapeutic products - Part 1: General requirements
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 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 E1880-12(2020) - Standard Practice for Tissue Cryosection Analysis with SIMS
ASTM E1874-14 - Standard Test Method for Recovery of Microorganisms From Skin using the Cup Scrub Technique
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 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 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 E2865-12(2018) - Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials
ASTM E1564-00(2019) - Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
Blood Products Testing
Vaccine Research and Development Studies
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