The biopharmaceutical sector is now going through a significant transition toward continuous bioprocessing which is currently taking place. In contrast to the conventional batch processing method, which is characterized by the presence of distinct phases and interim holding tanks, the consistent bioprocessing method functions without any interruptions. Within the confines of a single interconnected system, cells are cultivated, and the product of interest is continually collected and purified. This not only eliminates the downtime that occurs between batches, but it also makes it possible to make more effective use of the resources and equipment that are available.
According to one of the market research studies that has been published, the current bioprocessing market is projected to be worth more than $218 million in 2023 and is expected to reach more than $599 million by 2028, exhibiting a significant compound annual growth rate (CAGR) of 22.4% during the period of forecasting that spans from 2023 to 2028. This growth is primarily driven by a number of factors, including the increasing demand for biopharmaceuticals, the growing adoption of continuous bioprocessing among contract manufacturing organizations (CMOs) and contract manufacturing organizations (CMOs) of biomanufacturing, and the advantages of continuous bioprocessing over batch and fed-batch modes of production.
Understanding the Market Dynamics Through the Application of PAT to the Optimization of Continuous Bioprocesses
The term process analytical technology (PAT) refers to a system that is composed of analytical instruments that are used for the purpose of monitoring and controlling industrial processes. Tools for process analysis and testing (PAT) such as spectroscopy and chromatography, in addition to sensor technologies, make it possible to perform continuous monitoring of key process parameters (CPPs) and critical quality attributes (CQAs) in real time. This enables producers to instantly identify any form of deviation and make the necessary modifications in order to preserve the integrity of the process as well as the quality of the product. The PAT moves ahead and assists the manufacturers in optimizing their operations in a variety of ways, including the following:
- Process knowledge and Control – PAT assists with a deeper knowledge of the bioprocessing environment by providing insights into connections between the process parameters and product qualities. This allows for a better understanding of the bioprocessing environment. This information may be used by manufacturers in order to develop sophisticated control techniques such as feedback control loops or even model predictive control in order to maximize the performance of the process and guarantee that the product is consistent.
- Through the identification of possibilities for process intensification as well as efficiency improvements, PAT-enabled optimization makes it possible to simplify bioprocessing activities, which results in decreased cycle times and greater productivity. Manufacturers are able to cut cycle durations, increase throughput, and also improve overall productivity by continuously monitoring and adjusting process parameters. This allows them to move forward and achieve their goals.
- Quality by Design Execution – PAT is in agreement with the concepts that apply to quality by design (QbD) since it assists in the construction of strong processes that go on to create goods that consistently have the quality characteristics that are required. This allows producers to move ahead and embed quality into the process from the very beginning, hence decreasing the risk that is associated with product failures as well as deviations. This is accomplished by incorporating PAT tools into the design and development stages.
- A decrease in manufacturing costs in addition to a reduction in waste Consistent monitoring and control, which is made possible by PAT, may assist discover and minimize process inefficiencies, hence reducing the amount of raw materials used, the amount of energy used, and the amount of waste generated. As a result, not only does this result in reduced manufacturing costs, but it also helps to contribute to the achievement of sustainability goals by reducing the negative impacts on the environment.
Regarding the facilitation of regulatory compliance, PAT provides manufacturers with the tools and the data that are required to show to regulatory authorities that they have a thorough grasp of the process, that they have control over it, and that they are consistent with it. Streamlining regulatory submissions, accelerating product approvals, and ensuring compliance with stringent regulatory standards are all things that manufacturers may do via the use of optimization tactics that are facilitated by PAT.
PAT-enabled optimization, in its totality, may be considered a major opportunity within the continuous bioprocessing sector. This potential encourages producers to reach greater levels of process efficiency, quality, and regulatory compliance, which ultimately leads to increased profits.
When it comes to continuous bioprocessing, the popularity of chromatography systems is driven by high productivity and cost.
It is important to note that the market for consistent bioprocessing is further subdivided by product into chromatography systems with filtering systems along with devices; consumables; bioreactors; cell lines, cell culture medium, buffers, and reagents; and also other items. This is something that should be taken into consideration. Both the chromatography systems and the consumables include a variety of components, including resins, membranes, buffers, solvents, columns, reagents, and other consumables such as autosamplers, fittings, and tubing detectors, amongst other components. When it comes to continuous downstream bioprocessing, consistent chromatography methods are very necessary in order to obtain high purity for the proteins. These procedures are at an advanced level and provide a number of exciting options. By operating numerous chromatography columns in a manner that is either countercurrent or even concurrent, it is possible to keep the process going continuously. This is due to the fact that the loading is done in the first column, and all the other following steps, such as elution, regeneration, washing, and re-equilibration, happen to be performed inside the succeeding columns. A number of chromatographic techniques are included in the continuous mode of operation. These techniques include countercurrent chromatography (CCC), countercurrent tangential chromatography (CCT), multicolumn countercurrent solvent gradient purification chromatography (MCSGP), simulated moving bed (SMB) chromatography, and continuous annular chromatography (CAC).
The necessity for intensification of the upstream bioprocess in order to raise productivity and minimize manufacturing costs has arisen as a result of an increase in the demand for biologics. This is because of the rising demand for biologics. The National Center for Biotechnology Information (NCBI) has published a number of studies that demonstrate the successful implementation of integrated continuous bioprocessing in the manufacturing of monoclonal antibodies (mAbs). These investigations have shown that the practice is effective. For instance, a researcher was able to produce a nearly eighty percent increase in productivity by using one-column continuous chromatography (OCC) and perfusion bioreactor culture with alternative tangential flow technology (ATF).
Furthermore, businesses happen to be rapidly transferring their emphasis to chromatography systems so as to expedite their manufacturing operations and also match expanding industry needs. After that, in June of 2023, Waters Corporation and Sartorius AG made an announcement on their collaboration to develop integrated analytical solutions for the biomanufacturing process that occurs farther downstream.
The importance of processing farther downstream
Downstream processes happen to have a series of purification steps along with separation steps that are aimed at isolating and purifying the anticipated biopharmaceutical product from the intricate mixture pertaining to cellular components, media, and contaminants that are generated during upstream production. These operations often result in the production of items such as cell filtration systems, devices, chromatography systems, and consumables, in addition to accessories and other products that are linked with them. In particular, continuous chromatography systems are redefining downstream purification by allowing continuous separation as well as the purification of biopharmaceutical products that have outstanding accuracy and throughput. This is a significant step forward in the process of purifying downstream goods. It is important to note that periodic countercurrent chromatography, also known as PCC, continuous CTC, MCSGP, and SMB, as well as aqueous two-phase extraction, also known as ATPS, has been successfully utilized for the purpose of continuous capture from the process development scale all the way up to the manufacturing scale in large biopharmaceutical companies. This has enabled these companies to avoid the potential bottlenecks that could occur in the process. The efficiency of the process, the quality of the result, and the cost of the items are all improved by these technicians. MabSelect Sure PCC-Cytiva and Poros ProA-Thermo Fisher Scientific are two examples of the many resins that are available for the Protein A resin screening stage. These resins are accessible throughout the continuous capture phase of the process. In the years to come, it is projected that a greater number of midsize biotech businesses, in addition to compound development and manufacturing organizations (CDM).
An increasing emphasis on lowering production costs in the case of biosimilars and innovator drugs; rising technological advancements such as single-pass tangential flow filtration and multicolumn chromatography; the increasing need for intensification of the downstream bioprocess as a result of an increased titer; and the growing demand for biopharmaceuticals are some of the factors that are responsible for the segment’s high share within the market. Because of these factors, the segment has a high market share.
An Application-Based Analysis of the Market for Continuous Bioprocessing
mAbs, vaccines, cell and gene therapy, and other applications are some of the applications that are included in the consistent bioprocessing market segmentation. This market segmentation is based on the application. It just so happens that monoclonal antibodies constitute one of the most significant subsets of the biotechnology medicine industry. The large share as well as the high growth rate within this segment can be attributed to the growing pharmaceutical research and development drug pipeline, the growing emphasis on continuous bioprocessing in the production of monoclonal antibodies, the growing clinical pipeline of monoclonal antibodies, and the growing regulatory approvals pertaining to therapeutic antibodies. All of these factors have contributed to the segment’s growth.
As a result of the fact that continuous bioprocessing is quickly gaining pace within monoclonal antibody bioprocessing, it has the potential to provide a number of benefits, including smaller facility footprints, lower investment costs, more flexibility, and economies of process. Following the commercial success of mammalian cell-derived monoclonal antibodies (mAbs), there has been a surge in the need for revolutionary single-use bioreactor systems. These systems are able to deliver significantly improved levels of productivity and flexibility, while also lowering prices. As a result of the successful demonstration of the viability of a totally integrated continuous process from the pilot size bioreactor to the drug substance, a research has been conducted, which has paved the path for its wider implementation within the industry.
In addition, the rising prevalence of cancer and the rising need for cancer treatments are two other factors that are contributing to the expansion of the market within this particular category. On the other hand, monoclonal antibodies (mAbs) have less adverse effects than chemotherapy does. As an example, the rise of novel classes of monoclonal antibodies (mAbs) that are both more effective and efficient, such as anti-PCSK9 monotherapy, is another significant element that contributes to the expansion of the market. The patents for some of the most successful monoclonal antibodies (mAbs), including Humira, Rituxan, Avastin, and Pembrolizumab-Keytruda, are expected to expire within the next several years. Due to the fact that patents have been lost, biopharmaceutical firms have been compelled to go forward with the incorporation of monoclonal antibodies (mAbs) into their medication production pipeline. When it comes to cost-effective methods such as continuous bioprocessing, demand is expected to increase as a result of the growing pharmaceutical drug pipeline as well as the growing number of regulatory approvals for the modular drug delivery systems (mABs).
Final Thoughts
The continuous bioprocessing industry is now at the forefront of innovation, and as a result, it is positioned to transform the production procedures of pharmaceutical companies all over the world. This is something that should be duly taken into account. When compared to standard batch processes, consistent bioprocessing offers benefits that are unrivaled in terms of efficiency, productivity, and quality control. This is because the production flow of consistent bioprocessing is smooth and continuous. The market is being driven by a number of factors, including an increasing demand for biopharmaceuticals, the emergence of integrated end-to-end continuous bioprocessing, regulatory and government initiatives for innovative technologies that are favorable, and a growing adoption among both contract manufacturing organizations (CMOs) and contract manufacturing organizations (CMOs). It is true that the market is seeing rapid development and diversity as a result of the adoption of continuous production processes by pharmaceutical producers. Continuous bioprocessing solutions are being implemented across the whole biopharmaceutical manufacturing workflow, beginning with the upstream processes of cell culture and fermentation and continuing all the way down to the downstream production processes of purification and formulation. Additionally, the incorporation of process analytical technology, also known as PAT, in addition to automation, further contributes to the enhancement of process control and optimization, which ultimately results in increased efficiency and ensures compliance with regulatory requirements.
