The biopharmaceutical industry focuses on the research, development, and
production of medical drugs derived from biological sources. This
sector plays a critical role in advancing healthcare by providing
innovative treatments for a wide range of diseases including cancer,
diabetes, and autoimmune disorders. Through cutting-edge biotechnology,
the industry seeks to improve patient outcomes and quality of life.
Biopharmaceuticals Testing and Research Services
Contract Laboratory can help you with all your Biopharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:
In vitro bioassays: Laboratory tests conducted on samples to assess the potency and toxicity of biopharmaceutical products
Immunogenicity assays: Tests to evaluate the immune response induced by biopharmaceuticals
important for safety assessment
Stability testing: Assessing how the quality of a biopharmaceutical varies over time under the influence of environmental factors like temperature and light
Purity and impurity analysis: Techniques such as chromatography and mass spectrometry are used to determine the purity levels and identify any impurities in the products
Type of Biopharmaceuticals 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 Biopharmaceuticals finished products, processes, systems, in-process materials, raw materials and components such as:
Monoclonal antibodies (mAbs): Engineered proteins that target specific antigens found in diseases
Vaccines: Biological preparations that provide immunity against various infectious diseases
Recombinant proteins: Proteins derived from recombinant DNA technology
used for therapeutic purposes
Gene therapies: Treatments that involve altering the genetic material of a person's cells to fight or prevent disease
Cell therapies: Therapies in which viable cells are injected
grafted
or implanted into a patient to effect a medicinal benefit
Biosimilars: Biologically similar products to already approved biopharmaceuticals
offering alternatives to existing biologic therapies
Biopharmaceuticals Test Methods and Standards
Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Biopharmaceuticals test methods, standards, procedures or specifications.
ISO 7886 - Sterile hypodermic syringes for single use
USP <616> - Bulk Density and Tapped Density of Powders
ISO 11418-5:2015 - Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies
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 F895-11(2016) - Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
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 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
ASTM F3142-16 - Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs
ASTM F2315-18 - Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
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 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 E1564-00(2019) - Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
Need Biopharmaceuticals Testing or Scientific Research Services?
We can help with all your Biopharmaceuticals lab testing and scientific research needs! Call 1-855-377-6821 or