Himanshu Nivsarkar, senior manager marketing New Product Introduction, 3M Separation and Purification Sciences Division, explains the benefits and challenges of both single-use and stainless-steel bioreactors, and which is best for your facility.
Key highlights:
- Benefit of single-use reactors: can produce multiple different products in specific quantities and cut out steps in the process to increase the rate at which drugs are being produced. They are flexible in that they can change and over scale quickly and efficiently without lowering plant capacity utilisation.
- Benefit of stainless steel reactors: suitable for high mass generation over long term. Therefore, are favoured in situations where process scale varies predictably on a long term basis with limited changes.
- Challenge of single-use reactors: technology features, e.g. chromatography systems, have not been sufficiently well developed to gain wide-spread commercial manufacturing adoption.
- Challenge of stainless steel reactors: flexibility in scaling and scaling out during clinical and commercial manufacturing is difficult to achieve. This can decrease capacity utilisation rate and lengthens the response time to change in market and patient demand.
- Flexible manufacturing has led to a hybrid implementation in the biopharmaceutical industry.
In the last several years, biopharmaceutical manufacturers have faced demand for both blockbuster oncology and autoimmune drug production in large quantities, and drugs for niche disease areas produced in smaller quantities.