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Biologics Laboratory Services

Biologics, Biosimilars

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
Blood Products Testing

Blood Products Testing

Vaccine Research and Development Studies

Vaccine Research and Development Studies


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