The biopharmaceutical industry happens to be experiencing a massive shift toward continuous bioprocessing. Unlike traditional batch processing, which happens to be involving discrete stages with intermediate holding tanks, consistent bioprocessing operates seamlessly. Cells get grown, and the desired product is continuously extracted as well as purified in a single connected system. This goes on to eradicate the downtime between batches and, at the same time, also allows for further efficient usage of resources and equipment.
As per one of the published market research reports, the ongoing bioprocessing market is anticipated to be worth more than $218 million in 2023 and is all set to reach more than $599 million by 2028, showcasing quite a prominent CAGR of 22.4% throughout the forecast period of 2023-28. This growth happens to be primarily driven due to the factors like rising demand when it comes to biopharmaceuticals, growing adoption in terms of continuous bioprocessing among the CDMOs and CMOs of biomanufacturing, and also the advantages of continuous bioprocessing over batch and fed-batch modes.
Discovering the Market Dynamics: PAT-Enabled Optimization of Continuous Bioprocesses
Process analytical technology- PAT happens to be a system pertaining to analytical tools that get used to monitor as well as control manufacturing processes. PAT tools like spectroscopy, chromatography, as well as sensor technologies, enable continuous tracking when it comes to critical process parameters- CPPs and critical quality attributes- CQAs and that too in real time. This helps manufacturers go ahead and promptly detect any kind of deviation and make the required adjustments so as to maintain process integrity along with product quality. PAT goes ahead and helps the manufacturers optimize their overall processes in many ways:
• Process Understanding as well as Control- By way of offering insights into relationships between the process parameters as well as product attributes, PAT helps with a deeper understanding of the bioprocessing environment. Manufacturers can make use of this knowledge so as to implement advanced control strategies like feedback control loops or even model predictive control in order to optimize process performance as well as ensure product consistency.
• Decreased cycle times along with increased productivity- PAT-enabled optimization enables streamlined bioprocessing operations by way of identifying opportunities for process intensification as well as efficiency improvements. Through continuous monitoring as well as optimizing process parameters, manufacturers can go ahead and thereby reduce cycle times, elevate throughput, and also enhance complete productivity.
• Quality by Design Execution- PAT happens to sync with the principles pertaining to quality by design (QbD) by way of helping the design of robust processes that go on to consistently deliver products with desired quality attributes. By way of integrating PAT tools in the design and development phases, manufacturers can go ahead and build quality into the process from the outset, thereby minimizing the risk pertaining to product failures as well as deviations.
• Decreased Manufacturing Costs along with Waste- Consistent monitoring as well as control enabled by PAT can go on to help identify and also reduce process inefficiencies, lessening raw material consumption, energy use, along with waste generation. This not only goes on to lower manufacturing costs but, at the same time, also contributes to sustainability objectives by way of minimizing environmental effects.
• Facilitation pertaining to Regulatory Compliance- PAT offers manufacturers the tools as well as the data that’s needed to demonstrate process understanding, control, and consistency to the regulatory authorities. By way of implementing PAT-enabled optimization strategies, manufacturers can go ahead and streamline regulatory submissions, speed-up the product approvals, and also ensure compliance with the strict regulatory requirements.
In its entirety, PAT-enabled optimization goes ahead and serves as a powerful opportunity within the continuous bioprocessing market, thereby encouraging manufacturers to achieve higher levels pertaining to process efficiency, quality, and regulatory compliance.
High productivity and affordability drive adoption in terms of chromatography systems in continuous bioprocessing
It is well to be noted that the consistent bioprocessing market happens to be further segmented by product into chromatography systems with filtration systems along with devices; consumables; bioreactors; cell lines, cell culture media, buffers, and reagents; and also other products. The chromatography systems as well as consumables have in them resins, membranes, buffers, solvents, columns, reagents, and other consumables like autosamplers, along with fittings and tubing detectors, among others. Consistent chromatography techniques are indeed critical in continuous downstream bioprocessing so as to achieve high purity for the proteins, and these processes happen to be at an advanced level and have several opportunities. Continuous operation can be maintained by way of running multiple chromatography columns in countercurrent or even in a concurrent manner. This is due to the fact that the loading is done in the first column, and all the other following stages, such as elution, regeneration, washing, and re-equilibration, happen to be completed within the succeeding columns. The continuous mode of the operation goes on to 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.
Due to an increased demand pertaining to biologics, the requirement for intensification of the upstream bioprocess so as to boost productivity as well as lower manufacturing costs has risen. There happen to be several studies that have been published by the National Center for Biotechnology Information- NCBI thereby showing the successful application of integrated continuous bioprocessing in the production of monoclonal antibodies- mAbs. For example, a study achieved an almost 80% rise in productivity by way of utilizing one-column continuous chromatography- OCC and perfusion bioreactor culture with alternate tangential flow technology- ATF.
Furthermore, manufacturers happen to be increasingly shifting their focus to chromatography systems so as to streamline their production processes and also meet growing market requirements. In June 2023, Waters Corporation and Sartorius AG went on to announce a partnership to come up with integrated analytical solutions for downstream biomanufacturing.
Emphasis on Downstream Processing
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 processes go on to typically include products such as cell filtration systems as well as devices, chromatography systems, and consumables, along with associated accessories and other products. Continuous chromatography systems, in particular, are revolutionizing downstream purification by way of enabling continuous separation as well as the purification of biopharmaceutical products that have exceptional precision and throughput. It is well to be noted that periodic countercurrent chromatography- PCC, continuous CTC, MCSGP, SMB, as well as aqueous two-phase extraction- ATPS has been successfully made use of for the continuous capture from process development to the manufacturing scale all throughout large biopharma companies to thereby avoid the potential process bottlenecks. These techs enhance the process efficiency, product quality, as well as cost of goods. For continuous capture, there happen to be a variety of resins that are available for the Protein A resin screening step, which include MabSelect Sure PCC-Cytiva and Poros ProA-Thermo Fisher Scientific. Such technologies are anticipated to be adopted by more midsize biotech companies as well as CDMOs in the years to come.
Hence, growing focus stressing on reducing production costs in the case of biosimilars and innovator drugs; rising technological advancements like single-pass tangential flow filtration and multicolumn chromatography; the elevating need for intensification of the downstream bioprocess because of an increased titer; and the growing demand for biopharmaceuticals happen to be some of the factors that are responsible for the segment’s high share within the market.
Application-Based Analysis of the Continuous Bioprocessing Market
Based on the application, the consistent bioprocessing market happens to be segmented into mAbs, vaccines, cell as well as gene therapy, and also other applications. mAbs happen to form one of the largest segments pertaining to the biotechnology drug market. The large share as well as the high growth rate within this segment happen to be attributed to the increasing pharmaceutical R&D drug pipeline, the rising focus on continuous bioprocessing in the production when it comes to mAbs, the rising clinical pipeline of monoclonal antibodies; and also growing regulatory approvals pertaining to therapeutic antibodies.
Continuous bioprocessing happens to be rapidly gaining momentum within monoclonal antibody bioprocessing, thereby offering potential advantages like smaller facility footprints, lesser investment costs, flexibility, and process economies. The commercial success of mammalian cell-derived mAbs has gone on to lead to an increased demand for novel single-use bioreactor systems that happen to provide much better productivity and flexibility and also reduce costs. A study has gone on to successfully demonstrate the feasibility of a completely integrated continuous process from the pilot scale bioreactor to the drug substance, thereby paving the way for its broader adoption within the industry.
Other elements that happen to be supporting market growth within this segment go on to include the growing incidence of cancer as well as the growing demand for cancer therapeutics. mAbs go on to offer minimal side effects as compared to chemotherapy. For example, the new emerging classes of more effective as well as efficient mAbs, like anti-PCSK9 monotherapy, are also a major factor that contribute to market growth. Blockbuster mAbs such as Humira, Rituxan, Avastin, and Pembrolizumab-Keytruda are anticipated to lose their patents within the coming years. The loss of patents has gone on to prompt the biopharmaceutical companies to go ahead and incorporate mAbs within their drug manufacturing pipeline. Hence, the rising pharmaceutical drug pipeline as well as rising regulatory approvals for the mABs are all set to drive demand when it comes to cost-efficient approaches like continuous bioprocessing.
Conclusion
It is well to be noted that the continuous bioprocessing market happens to stand at the forefront of innovation, thereby poised to revolutionize pharma manufacturing practices across the globe. Due to its seamless and uninterrupted production flow, consistent bioprocessing goes on to offer unparalleled advantages when it comes to efficiency, productivity, and quality control vis-Ã -vis traditional batch processes. The market happens to be driven by a series of factors, such as an increasing demand pertaining to biopharmaceuticals, emergence when it comes to integrated end-to-end continuous bioprocessing, regulatory and government initiatives for innovative technologies that are favorable, and also a growing adoption among CDMOs as well as CMOs. As pharmaceutical manufacturers go ahead and embrace continuous manufacturing practices, the market is indeed witnessing fast expansion and diversification. Right from upstream cell culture as well as fermentation to downstream purification along with formulation, continuous bioprocessing solutions are getting deployed throughout the entire biopharmaceutical production workflow. Furthermore, the integration of process analytical technology- PAT as well as automation further goes on to enhance process control along with optimization, thereby driving efficiency and ensuring regulatory compliance.
