Downstream Services

Downstream Services

Technical Services and Support

Process Development
Process Evaluation and Validation
Clinical and Commercial Manufacturing
Technology Transfer
Comparability
Quality by Design
Regulatory Support

Types of Large Molecules 

Antibodies
– Various Species of IgG and IgM
Antibody Fragments and Derivatives
– Examples: Fab, F(ab)2, scFV, BiTE, sdAb, Bispecific Antibodies
Recombinant Proteins
– Examples: Fc-Fusion Proteins, Tagged Proteins (His, FLAG, GST, MBP, etc.)

Chromatography

Affinity
– Examples: Protein A/G/L, CaptureSelect, IMAC, CHT, etc.
Mixed-mode
Ion Exchange
Size Exclusion
Hydrophobic Interaction
Reverse Phase

Processing

Clarification
Polishing
Viral Inactivation, Filtration, and Clearance
Ultrafiltration/Diafiltration
Sterile Filtration
Formulation
Protein Labeling and Conjugation
Final Fill (Small Batch Only)

Outsourcing Support

Viral Clearance
Formulation Studies
Final Fill (Large Batch)