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Microbial process translation--laboratory to pilot plant at the Frederick Cancer Research Center
Summary
The FCRC pilot plant successfully scaled up laboratory processes for producing biologics like interferon and carboxypeptidase G1. Operations included staff training and equipment optimization for versatile biomanufacturing.
Area of Science:
- Biotechnology
- Bioprocess Engineering
- Pharmaceutical Manufacturing
Background:
- The Facilities for Comparative Medicine (FCRC) pilot plant aimed to bridge laboratory-scale discoveries with pilot-level production.
- Enhancing operational versatility and capacity was crucial for supporting diverse research and development programs.
Purpose of the Study:
- To detail the operational activities and production capabilities of the FCRC pilot plant.
- To demonstrate the successful translation of laboratory processes to pilot scale for various biologically active molecules.
Main Methods:
- Pilot plant operations included staff training, equipment modification, and process validation.
- Specific production campaigns were undertaken for interferon, carboxypeptidase G1, phenylalanine ammonia lyase, staphylococcal nuclease, and cysteine desulfhydrase.
Main Results:
- Established a production process for interferon and explored lymphokine production.
- Produced cell paste for carboxypeptidase G1 and large quantities of phenylalanine ammonia lyase.
- Generated staphylococcal nuclease, cysteine desulfhydrase, and investigated novel agents like piperazinedione 593A.
Conclusions:
- The FCRC pilot plant demonstrated significant capabilities in scaling up diverse bioproduction processes.
- Successful operations supported preclinical and clinical studies, validating the plant's role in biopharmaceutical development.