1. Since their introduction in 1982, biologics have gained popularity owing to their therapeutic efficacy, favorable safety profiles and ability to treat a wide variety of disease indications, which are otherwise hard to treat. In fact, in the past two decades, over 170 biopharmaceuticals have already been granted approval by the FDA and over 7,500 biological interventions are under evaluation in clinical trials.
2. It is a well-known fact that the commercial and clinical-scale manufacturing of such complex biomolecules require highly specialized bioprocessing equipment to facilitate the maintenance of ideal conditions, such as optimal temperature, pH, dissolved oxygen, fluid delivery, and other critical process parameters that are essential for steady cell growth. Bioreactors are capable of providing such optimal conditions and are critical to the upstream biomanufacturing process.
3. These systems are designed to increase the concentration of viable cells, thereby enabling the production of large amounts of recombinant proteins, such as vaccines, fusion proteins, antibodies and enzymes.
4. Apart from producing conventional therapeutic proteins, bioreactors can also be used to produce advanced medicinal products (ATMPs), namely cell-based and oligonucleotide-based therapies, retroviral vectors for gene therapy and cellular components of three-dimensional tissue / artificial organs. In contrast to bioreactors, fermenters are used for the anaerobic cultivation of microbial (fungal or bacterial) cell populations to produce biologics that do not require significant post translational modifications.
5. It is worth highlighting that the use of fermenters for the manufacturing of bioproducts provides faster development, higher yields and quality, reduced variation between batches, better scalability, and lower production costs, in comparison to the biomanufacturing carried out in bioreactors.
