MULTIPARAMETRIC ANALYSES OF HYBRIDOMA GROWTH ON GLASS CYLINDERS IN A PACKED-BED BIOREACTOR SYSTEM WITH INTERNAL AERATION - SERUM-SUPPLEMENTED AND SERUM-FREE MEDIA COMPARISON FOR MAB PRODUCTION

Monoclonal antibodies are one of the most important products of biotec hnology and laboratories and companies all over the world are pursuing their large-scale production. Herein we report a protocol for hybrido ma cell cultivation over small glass cylinders inside a 3 liter biorea ctor vessel which leads to the production and purification - in order of grams - of one MAb intended for human therapeutic use. This protoco l proved to be simple, reproducible and cost effective. Three trials a re reported: the first two using conventionally serum-supplemented med ium culture and producing 3.15 and 2.1 g of purified MAb in 30 and 21 days respectively, and the third one using serum-free medium culture a nd producing 6 g of purified MAb in 36 days. We have ascertained the s tability of the hybridoma by its cloning directly in serum-free medium . The downstream processing of the serum-free trial was done in a sing le step, concentrating large volumes of supernatant while simultaneous ly purifying the antibody.