Biologics

Introduction or modification of DNA in targeted tissues

• Introduction or modification of DNA in targeted tissues
• Cell line development, optimization of culture conditions, authentication, and characterization
• Ex Vivo Cell Modification for Gene Editing (e.g., CRISPR)
• Analytical Characterization
• Purity and Identity Testing
• Analytical Development and Phase-Appropriate Method Validation
  • Purity and identity, size and conformation, nucleic acid sequence verification
• ELISA, qPCR, next-gen sequencing, high resolution mass spectrometry
• Potency assays, including cell-based potency assays and LBAs
• Viral Vector Characterization
• Nanoparticle and Lipid-based Formulations
• Gene Editing Characterization
• Protein Expression and Functionality Testing
• Stability and Storage Analysis
• Formulation development, including excipient screening, accelerated stability, and optimization

Natural or engineered proteins intended to replace absent or abnormal proteins or to affect another function

• MCB/WCB generation and long-term storage
• Cell line development
• Small scale studies
• Analytical Characterization Services
  • Identity Testing, Purity Analysis, Concentration
    Determination, Post-Translational
    Modifications (PTMs), Bioactivity Assays,
    Protein Aggregation, Folding and
    Conformation, Endotoxin Testing, HCP
    Analysis, Isoelectric Point Determination,
    Protein Sequencing, Protein activity assays,
    R&D purification
• Formulation Development
• Stability Testing
• Shelf-life and storage stability studies (freeze/thaw
  cycles, different pH or temperature conditions)

Mass production of antibodies that recognize specific targets

• Cell-line expansion and optimization
• Cell-based assays and potency assays
• Cell culture and cell culture process optimization
• Analytical characterization:
  • Size and structure, glycosylation profiling and analysis,
    identity testing, peptide mapping and sequencing,
    viscosity and aggregation, charge variant analysis,
    stability and shelf-life analysis, protein quantification
    and purity, analysis with purified mAbs,
    characterization of ADCs, in vitro activity assays,
    pharmacokinetic assays
• Formulation work:
  • Buffer optimization, excipient screening, adjuvant
    studies, stability studies to study the effects of
    temperature, pH, and other factors on the stability of
    the mAbs, forced degradation studies,
    container/closure system compatibility
• Regulatory support

Manipulation of immune cell function and regenerative medicine to combat disease

• Cell line maintenance
• Cell expansion and proliferation
• Genetic profiling
• Transfection and gene editing
• Cell viability and proliferation assays
• In vitro efficacy testing
• Cryopreservation and thawing protocols
• Formulation development
• Analytical characterization services:
  • Identity testing, potency assays, genomic integrity, and stability testing
• Bioanalytical testing