Antibody Manufacture, Disposable Systems

Abstract

The growing demand for biotherapeutics and, in particular, antibodies has resulted in an increasing use of disposables over the last ten years. This concerns both, process development and commercial manufacturing, where animal cells are grown in suspension or on microcarriers. The use of disposable devices have been implemented in all three stages of biotechnological production processes: (i) upstreaming, (ii) downstreaming as well as (iii) final formulation and filling. The majority of applications are to be found in upstream processing. Here, disposable expendable laboratory items, simple peripheral elements, and equipment for unit operations are well‐established. Among the components listed, disposable bioreactors have achieved the highest growth rate over the last year. Following an introduction in which the term “single‐use” is defined, a general overview of single‐use devices in antibody production processes is given. We focus on frequently used disposable bioreactor types, their characteristics, and obtainable results, and discuss apparent trends for disposables in antibody manufacture.

Advances in Bioreactor Systems for the Production of Biologicals in Mammalian Cells

“…Crossed columns represent k L a values of the various culture systems. Black column represents the k L a range for 10 × 10 6 cells mL −1 with varying air saturation and the striped column represent the k L a values required for different cell densities at 40 % of air saturation – data taken from 13, 31, 65, 77, 83, 84, 99, 102, 122, 127–130 (supplementary dataset: DOI: https://doi.org/10.25375/uct.12263141).…”