Optimisation of small-scale biomanufacturing processes

INTEGRA Biosciences has published a new technical field report that discusses how replacing traditional roller bottle cell cultivation with CELLine bioreactors, allowed a contract manufacturer to reduce the cost and time for production of one gram of monoclonal antibody while increasing product quality.

The parameters influencing the selection of a culture system include the amount of product required, the product quality as well as the target cost and duration of the production process. Until relatively recently a trade-off between the last three factors - cost, time and quality - has been generally necessary. In this new field report the authors describe an innovative culture system and protocol that make it possible to optimise all three factors simultaneously.

The field report describes the shortfalls encountered in manufacturing a batch of monoclonal antibody with roller bottles and compares this with the advantages of using the CELLine bioreactor. A cost analysis, including the expenses from disposables, medium, serum and labour, is presented for the production of 1000mg of antibodies comparing the CELLine bioreactor with roller bottles. The analysis demonstrates using the CELLine bioreactor, labour costs were reduced by nearly 60% compared to the roller bottle system, mainly due to greatly reduced amount of supernatant that needed to be handled. Despite the relatively high costs of the CELLine bioreactors, the 30% reduction in production costs for 1 g of purified monoclonal antibody, the significant reduction of the labour costs and of the material used for purification of the monoclonal antibody more than compensate for this initial expenditure. An additional economical advantage of CELLine often is achieved when the costs for equipment amortisation are considered.

The CELLine bioreactor combines the advantages of high cell densities achieved in a two-compartment system with the ease-of-use of a standard tissue culture flask, resulting in economically efficient biomanufacturing in the 50 -1000mg range. The presented benefits of monoclonal antibody production with the CELLine bioreactor also may be applied to the manufacturing of other biological products such as recombinant proteins and viral vectors, so that any laboratory with basic cell culture expertise can produce highly concentrated, high quality proteins in a cost efficient way.