Biopharma Services

Move your mouse over the chart to view more about each process. Click on a button to learn more.

Molecular Biology

Gene identification and cloning
Synthetic coding sequences
Codon optimization
mRNA structure optimization
Custom fusions, tags
Custom promoters and vectors

Expression

E. coli
Proprietary technology - ProCode
Saccharomyces cerevisiae
Pichia pastoris
Transient mammalian cell culture
Stable mammalian cell culture

Fermentation

Microbial fermentation up to 10 L
Upto 50 L mammalian cells
Media optimization
Chemically defined media

Documentation

Strain development report
Process development report
Batch production record

Downstream Processing

Chromatography
Affinity purification
Ion exchange
Hydrophobic interaction
Concentration
Diafiltration
Viral clearance

Scale-up and Phase I

Manufacturing to support POC, pre-clinical
   and Phase I studies
CMC and IND support

Upstream Processing

Inclusion body processing
Refolding
Lysate processing

Quality Assurance

SOPs
Calibration
Equipment qualification
GMP for Phase I IND
Raw material qualification
Vendor qualification
Equipment cleaning verification

Quality Control

Cell banks
In-process material
Assay development
Assay qualification
Endotoxin
HPLC
SDS-PAGE

Vybion’s Experience

  • Developed over 150 recombinant proteins as reagents, therapeutic targets, diagnostics, and therapeutic proteins. Experience across many therapeutic areas (autoimmune, immune regulators, cancer, diabetes, drug abuse, ischemia, antiviral, bone-related disease.)
  • Proprietary vectors and technologies
    • In-house vectors
    • ProCode
    • Proprietary pegylation technology to fine tune PK
  • Solubility optimization in E. coli with ProCode
  • Antibody Engineering
    • ProCode for selection and affinity maturation
    • Transient production to test sequence modifications (POM, POC, affinity)
    • Humanization
  • Transient transfection (up to 10L)
    • Adherent
    • Suspension
  • Bioassay development & qualification
    • Receptor-based assays
    • Reporter-based assays
    • Growth factor/cytokine assays
    • Affinity-based assays