ABSTRACT
This chapter provides some practical aspects of production in the three areas: fermentation, recovery, and purity analysis. The identity of recombinant interferon can be established not only by the antiviral or cytopathic effect inhibition assay but also at the genomic level. Production can be conveniently broken down into two major components: fermentation and recovery. Fermentations for production of human leukocyte interferon have been carried out at Hoffmann-La Roche according to established procedures and killed before harvesting during late logarithmic growth. Large-scale recovery of product from fermentation cell mass can be conveniently subdivided into two parts: isolation and purification. The high degree of purity of recombinant leukocyte interferon in clinical testing is made possible by the use of genetic engineering. From about 12 subtypes of human leukocyte interferons found in conventional tissue culture preparations, only one is produced in a recombinant E. coli fermentation.
