Biopharmaceutical Testing

Whether you’re with a biotech start-up or an established biopharma company, you need to evaluate the quality, purity, safety and other key attributes of candidate biological products through all phases of the preclinical and clinical development pipeline.

Biologic Analytics with an Expert Perspective

国家授权正规彩票平台 offers a comprehensive suite of testing services for complex biopharmaceutical/biotherapeutic products that include large biomolecules such as monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), RNA/DNA oligonucleotides, recombinant proteins/enzymes, peptides, lipids/micelles/vesicles (liposomes/exosomes/LNPs) and polysaccharides but also include biologics such as live/attenuated viruses (mammalian, bacteriophage, AAV/LVV) and live/attenuated bacteria. Our biopharmaceutical services include standalone analytical research and development, method validation, release testing, ICH stability and routine QC testing.

Biopharmaceutical/Biologics Testing

Our robust testing capabilities for large molecules and biologics include:

  • General characterization and compendial testing
  • Activity/potency bioassays
  • ID, purity and heterogeneity
  • Residual host cell protein and DNA
  • DNA/peptide sequencing
  • Residual process impurities
  • Safety/microbiological testing

Biopharmaceutical Tools

We use the following tools and technologies to conduct testing:

  • qPCR (QuantStudio 5)
  • ddPCR (Bio-Rad QX200)
  • Microplate Readers (SpectraMax M2, M3 and M5)
  • Gel/Plate Imaging (Bio-Rad ChemiDoc MP)
  • Next-Generation Sequencing (Illumina MiSeq)
  • Gel-Based Electrophoresis and Blotting
  • Ion Chromatography (ICS-5000+)
  • UPLC-UV/MS/CAD/FLD (Waters and Agilent)
  • High Field NMR (Agilent and Bruker)
  • Capillary Electrophoresis (cIEX and CE-SDS)
  • Cell Culture and Infectious Viral Titering
  • Automated DNA/RNA Purification (KingFisher Flex)
  • HIAC Particle Counting (PharmSpec)
  • Nanoparticle Size Analysis (NanoSight NS300)
  • Tecan Evo 100 Liquid Handler
  • ICH Stability Storage and Photostability Chambers

Common Biopharmaceutical Quality Attributes

Our experts specialize in testing services that include:

  • Titer/Potency
  • Host Cell DNA
  • Host Cell Protein
  • Impurities Analysis by ELISA or Plate-based Methods
  • Impurities Analysis by Chromatography or by NMR Spectroscopy
  • Particulate Analysis
  • Osmolality, pH, Conductivity, Ion Analysis, Purity
  • Safety QC, including Microbiology

Quality Assurance

Our teams of expert technicians design quality assurance programs to comply with:

  • 21 CFR Parts 210 and 211
  • 21 CFR Part 11
  • ICH Q1
  • ICH Q2
  • ICH Q6b
  • ICH Q7
  • ICH Q10

We handle the logistics of quality assurance testing, including:

  • Controlled document system (MasterControl)
  • Deviation/CAPA
  • Change control
  • OOS
  • Training
  • Vendor qualification
  • Internal audits
  • Data review
  • Material handling

Trust the analytical development and testing experts at 国家授权正规彩票平台 to rapidly advance your biologic for the greatest chance of success. Led by our deep experience and collaborative approach, we are committed to finding the shortest, most efficient path to success for our customers.