GMP PRODUCTION
CRI has two GMP production facilities with restricted access (card), HEPA-filtered air, clean steam, clean air, sticky mat entrance, ceramic ceiling/metal benches, eyewashes, sinks, autoclave, and separate rooms for gowning, locked storage, fermentation, protein purification and vialing.
- GMP-1 has a 150 L fermentor for yeast fermentation, a tangential flow filtration system for microfiltration, a large-capacity centrifuge for harvest and an AKTA purifier system for protein purification.
- GMP-2 has a 40 L fermentor for E. coli fermentation, a microfluidizer for cell disruption and an AKTA purifier system for protein purification.
Since the Institute was established we have produced a clinical grade of:
- DT-anti-CD3 recombinant immunotoxin for treatment of T cell lymphoma
- Protective Antigen/Lethal Factor for treatment of melanoma
- DT-IL3 (K116W) for treatment of acute myeloid leukemia
- Urokinase-cleavable Protective Antigen/FP59 for treatment of pancreatic cancer
The FDA has approved DT-GMCSF, DT-IL3 and DT anti-CD3 Investigational New Drug (IND) applications. CRI is currently working on SP-SAP and DT-IL3 (K116W) for IND application. SP-SAP is a drug candidate for pain relief.