The global pharmaceutical industry is evolving with the rising need for novel therapies in the changing disease landscape. As a result of rising prevalence of chronic infectious diseases as well as growing cancer incidences, market needs are shifting from traditional small molecules (chemicals) to large molecules (biologics).
Biopharmaceutical processing involves unique complexities in the overall process such as long running batches, batch automation and product quality which cannot be measured in real-time. To address the issues related to biopharma manufacturing, companies go for different types of manufacturing techniques to avoid batch contamination and on the other hand maintain product quality, leading to the adaptive manufacturing of biopharmaceuticals. Single use and modular technology along with a continuous processing approach is not only modernizing the industry, but also minimizing the risks associated with making changes to the existing system.
Single use bioreactors are being widely used in upstream biopharmaceutical manufacturing processes. Disposable technologies for downstream processes are making rapid advances, e.g. disposable, pre-packed chromatography columns. These provide seamless and scalable implementations to upstream and downstream operations in biopharmaceutical manufacturing.
Disposable production methods are generally used for lower volume manufacturing for clinical and commercial requirements. The disposable technology does not involve processes such as cleaning and sterilization of the bioreactor and saves time and reduces stress on the manufacturing staff. The capital expenditure is much lower compared to stainless steel bioreactor technologies but involves higher variable costs due to the need for replacement of disposable components. Key products consist of single use mixers, bag assemblers, disposable aseptic connectors, pre-packed chromatography columns, etc.
The single use bioreactors enable multi-product flexible manufacturing, easy transfer of operations, fast changeover, busy facilities and lean operations. Therefore, a shift is happening to flexible, small-volume manufacturing comprising of single-use systems with bioanalytical capabilities and exploring continuous processing technologies in modular facilities.
Over the past few years, several fundamental changes in the biopharma manufacturing process have occurred. By leveraging right first time and manufacturing 4.0 principles, the industry is looking to improve manufacturing efficiency, quality by design and compliance. Revolutionary disruption powered by an incredible shift in technologies is impacting many industries that will drive transformation in biomanufacturing. These changes are creating a paradigm shift in pharmaceutical manufacturing to more predictive and adaptive facilities that leverage modular technology disposable components, the Industrial Internet of Things (IIOT), smart objects, remote control, and augmented reality. These techniques greatly influence design, construction, layout, and operation of a plant – and, the timing and cost of the overall project while maintaining regulatory compliance.
IIOT has the potential to transform the pharma industry by offering value propositions like faster time to market, cost optimization, ensuring higher productivity. IIOT also permits smart warehousing and routing of products along with predictive maintenance of machine and equipment. Benefits include lowered costs, reduction in waste production and real-time visual feedback improving operational efficiency. IIOT is expected to find application in end-to-end digital integration across the manufacturing and drug delivery value chains.
The future of biopharma manufacturing lies in connecting data and processes, involving components of adaptive and modular manufacturing in a predictive and cognitive plant. This shall result in higher quality, efficiency, regulatory compliance and enable optimization, customization of processes and collaboration between all stakeholders involved in the manufacturing value chain. In addition, there shall be a reduction in time to market for biologics, errors due to process variability and associated costs giving manufacturers the competitive edge to stay on the growth path.