List of Services

Cell Culture Activities

Cell Banking (Seed, Master, Working)

Cell Line Characterization

Media Selection Studies / Wean - down of Cells

Sub cloning / Clone Selection

Bioreactor Activities

Stirred Tank Bioreactor Production

Disposable WAVE Bioreactor Production

Packed Bed Bioreactor Production

Hollow Fiber Bioreactor Production

Downstream Processing Activities

Purification Process Development

Viral Clearance Study

Preparation of Toxicology Material Lots

cGMP Therapeutic Purification

Downstream Processing Materials

cGMP Aseptic Filling

Protein Modification

Conjugation

Material Long - Term Storage

Regulatory Affairs / Quality Assurance and control

Regulatory Support

QC Analytical Testing

Clinical Trial Distribution

Assay Development

CTO Management

Stability Studies Program

Other Services
"Outside the Box" services

• Chemical modification and biochemical fragmentation of full length Monoclonal Antibodies.
• Conjugation of small molecule cancer drugs, toxins, dsDNA, metal chelators, and antibodies to other recombinant proteins.
• Downstream processing of proteins produced in Avian and Plant Transgenics as well as microbial feed streams.
• Sterile Custom Liquid Fills
• Regulatory Consulting\
• CMC for IND filings
• Reagent Kit Manufacturing and Assembly