Single-use Bioreactors - Design and principles

Since the 1980s, single-use bioreactors have contributed to the research and development of biopharmaceutical and biotechnological processes in search of innovation and productivity gains. While traditional stainless steel equipment remains the norm for large-scale production, disposable or disposable single-use equipment has taken on a predominant role in laboratories and pilot workshops, for the production of clinical trial batches and even production batches. Without the need for heavy infrastructure, disposable equipment offers flexibility and time-saving in implementation, flexibility, safety, reduced cross-contamination, and eliminates the need for cleaning, disinfection and sterilization, thus requiring less capital to initialize programs and assess their feasibility and potential. Particularly well suited to animal cell cultures (free or on supports), vaccine cultures and recombinant organisms, they meet a market need for rapid testing of innovations and research feasibility. The increased volumetric capacities offered by suppliers naturally make them the tools of choice for pilot process development, production of clinical trial batches and even production. For laboratory bioreactors, rigid resin materials are replacing glass and stainless steel in reusable bioreactors, while multilayer flexible films remain the standard for the manufacture of larger-capacity 2D pouches and 3D bags. The need to shorten development times and bring bioactive molecules to market, and the steady gains in process productivity that are reducing production volumes, mean that the prospects for their use in mixed and modular workshops are bright for years to come. Animal, insect, viral and recombinant cell cultures are the future of therapies. It is therefore crucial to reduce time-to-market and costs. The wide range of equipment on offer is growing in line with suppliers' innovations, and enables culture volumes ranging from milliliters to 2,000 L to be achieved. Current limitations on the pressure resistance and mechanical strength of materials have not limited the development of this market, which is making steady progress in production units to complement or even replace the stainless steel equipment used in conventional culture propagation installations. The growing use of single-use bioreactors is creating a dynamic of permanent innovation, combined with the rapid development of new technologies for the production of active biomolecules. Innovation in the design and shaping of flexible and rigid biocompatible polymeric materials for capacities of up to 2,000 L ensures the classic elementary functions of agitation, mixing and control of physiological conditions for cell growth. In this article, we describe the constant evolution of single-use culture equipment, an essential tool in the development of biopharmaceutical processes....