Biologics Testing Laboratories

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

Biologics Products Tested

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, Standards and Specifications:

Contract Laboratory helps with the testing, research, product development, certification, and inspection to many Biologics Test Methods, Standards, Specifications, Laws and Regulations including:

ANSI/AAMI BE83:2006/(R)2011 Biological evaluation of medical devices - Part 18: Chemical characterization of materials.
ASTM F3224 - 17 Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
USP (87) Biological Reactivity Tests
In Vitro (Cytotoxicity)
USP <1046> Cell and Tissue-based Products
USP <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing Scaffold Human Placental Connective Tissue Matrix Allograft
USP <127> Flow Cytometric Enumeration of CD34+ Cells
USP <89.1> Collagenase I
USP <1055> Biotechnology-Derived Articles ? Peptide Mapping
USP <124> Erythropoietin Bioassays
USP <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
USP <210> Monosaccharide Analysis
USP <212> Oligosaccharide Analysis
USP <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals
USP <507> Protein Determination Procedures
USP <509> Residual DNA Testing
USP <89.1> Collagenase I
USP <89.2> Collagenase II
USP <92> Growth Factors and Cytokines used in Cell Therapy Manufacturing
USP <89> Enzymes used as Ancillary Materials in Pharmaceutical Manufacturing
USP <90> Fetal Bovine Serum Quality Attributes and Functionality Tests
USP <130> Protein A Quality Attributes
USP <198> Nuclear Magnetic Resonance Spectroscopy Identity Testing of Bacterial Polysaccharides Used in Vaccine Manufacture
USP <1239> Vaccines for Human Use Viral Vaccines
USP <1235> Vaccines for Human Use ? General Considerations
USP <1238> Vaccines for Human Use Bacterial Vaccines
ASTM E2097-00 Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products
ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM E1326-15a Standard Guide for Evaluating Non-culture Microbiological Tests
ASTM E2720-16 Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses
ASTM F2131 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 E3060-16 Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
ASTM E1482-12( Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
ASTM F2149-16 Standard Test Method for Automated Analyses of Cells?the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
ASTM E1532 - 00 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of the Bisbenzamide DNA-Binding Fluorochrome