Our Services 2 - Blue Gown
Our Services 3 - Blue Gown Sitting

BioConjugation Process Development and Manufacturing

  • Bioconjugation development
  • Formulation development (liquid and lyophilized)
  • Process characterization
  • Non-GMP Bioconjugate production, small scale and toxicology
  • GMP Bioconjugate production scale
  • Storage and Handling, including high potency API

Biologic Process Development and Manufacturing

  • Biologic process development
  • Formulation development (liquid and lyophilized)
  • Process characterization
  • Non-GMP production, small scale and toxicology
  • GMP production scale

 

Small Molecule Drug Development and Manufacturing

  • Drug process development
  • Formulation development (liquid and lyophilized)
  • Process characterization
  • Non-GMP production
  • GMP production

Drug Product
Fill and Finish

  • Aseptic filling of sterile drug product into vials, syringes, cartridges, or ampoules
  • Lyophilization (freeze-drying) and capping
  • Storage of materials

The Complete Analytical Package

Em9Bio is an ISO/IEC17025:2017 Accredited FDA Registered GMP Compliant Analytical unit, Valentia Analytical, with the capability to perform a wide range of analytical testing including testing for biologics, small molecule compounds, peptides and medical devices. See the complete list of our analytical services below:

Biologics and Drug Testing

  • cGMP Lot release and stability
  • General characteristics, e.g., pH Osmolality, Appearance (EP, USP, JP, CHP), protein concentration, dissolution testing, subvisible particulates.
  • Purity and Impurities by HPLC, e.g., Size Exclusion Chromatography (e.g., aggregates and fragments), Reversed-Phase, Ion Exchange, and DAR (Drug to Antibody Ratio)
  • Purity and Impurities by CE, e.g., icIEF, CE-SDS reduced, CE-SDS non-reduced.
  • Purity by GC-MS, e.g., Residual solvents (GC-MS),
  • Impurities by ddPCR, e.g., residual host cell DNA
  • Impurities by ELISA, e.g., residual host cell proteins (CHOP)
  • Identity, e.g., LC-MS, NMR
  • Potency by Bioassay, e.g., Cell-based Cytotoxicity bioassay, Antibody-Dependent Cell-Mediated Cytotoxicity bioassay
  • Potency by ELISA, e.g., e.g., antigen binding ELISA
  • Safety, e.g., endotoxin, bioburden, mycoplasma, residual host cell DNA

Stability Storage

  • Liquid Nitrogen Cryotank, -196°C
  • Ultra-Low Deep Freezers, -80°C
  • Controlled refrigerators, 2-8°C
  • Accelerated Chambers, 25°C/60%RH
  • Stress Chambers, 40°C/75%RH

CMC (Chemistry, Manufacturing and Control)

  • Structural Characterization, e.g. LC-MS, LC-MS/MS, Differential scanning calorimetry, Circular Dichroism, NMR
  • Bioanalytical Testing e.g. Cell-based assays, antigen binding ELISA, ADCC assay, CDC assay, FcRn binding assay, FcgR receptor binding assays, ddPCR
  • Forced degradation studies
  • Reference material preparation, qualification and stability
  • Method development including cell-based bioassay
  • Method validation including cell-based bioassay
  • IND enabling structural characterization, small and large molecule
  • BLA enabling characterization, small and large molecule

Other Services

  • CMC regulatory support for IND and BLA
  • Technical Training
  • Investigation Support