Digital Bioprocessing Is Set To Improve Drug Product Quality

One of the market reports has gone on to show that the digital biomanufacturing segment is expected to grow at a CAGR of 11% between 2023 and 2035 and will be driven largely by digital transformation.

The influencing factors identified in the report are competitive pricing, higher competition, tech advancements, evolving regulatory guidelines, and, of course, the inflation rate. All these factors have led to what one may call industry 4.0 technologies. For example, digital biomanufacturing, also known as digital bioprocessing, has shown immense promise in helping to aid the robustness of the process as well as the quality of the drug product.

Since the COVID-19 pandemic hit, the biopharmaceutical sector has been under immense pressure to reduce the timelines of production and also enhance capacity when it comes to manufacturing, all without compromising the product. Elevated interconnectivity of technologies as well as equipment has also gone on to put demand on manufacturing operations.

When it comes to bioprocessing 4.0, the physical equipment gets integrated with the digital software as well as platforms so as to help in streamlining the entire biomanufacturing process. The examples include process analytical technologies, manufacturing execution systems, digital twins, and data analysis software.

Above 140 digital technologies have been developed at present or are being developed by 100 plus industry stakeholders so as to enable biologic manufacturing. Besides, of the technologies that presently enable smart biomanufacturing, 48% happen to be based on process analytical technologies, followed by 28% using manufacturing execution systems and 10% using digital twins.

When it comes to the technology type, the digital biomanufacturing segment for digital twins is anticipated to grow at 19% until 2035. The report also went on to identify that the rising popularity of cloud-based tech is also expected to hold a large market share.

The research also went on to highlight that more than 75 strategic collaborations pertaining to digital biomanufacturing have been modelled since 2018, which goes on to suggest that the software providers happen to be actively upgrading their technology-related capacities and are also accommodating the present as well as expected demand in terms of digital biomanufacturing.

The report also stated that digital bioprocessing is perceived to have changed manufacturing principles in areas such as operations activities, process development, logistics, as well as supply chain management as and when used in combination with technologies that happen to be advanced, such as AI, IoT, and machine learning.

It is well to be noted that last year, the quantity of approvals when it came to biologic drugs in the biotech sector only surpassed the approvals for small molecules. This was the time when almost half of the biologic approvals were allocated to novel classes of modalities such as antibody drug conjugates, cell and gene therapies, and bispecific antibodies.

The elevated demand for biologics along with consistent innovation has led to such outcomes, as per the report. Hence, there is a rise in the requirement concerning digitally led and connected end-to-end process solutions so as to improve bioprocess operations. Report says, currently, 20% of the organisations have already gone on to adopt a digitalized approach when it comes to biomanufacturing.

Numerous leading biopharma players, for example have gone on to claim to achieve a 40% rise in quality, a 15% reduction in cost, a decrease in process variability of 80%, and operational timelines that happen to be 20% shorter by making use of digital biomanufacturing advancements.

The digital transformation in biomanufacturing can aid in improving efficiency, getting a higher yield in product, better product quality, integrity of the data, less manual intervention, and a limited risk as far as contamination is concerned. Significantly, the report also went on to state that digital transformation has gone on to become an essential element when it comes to biopharma manufacturing.

At present, batch-to-batch variation as well as product validation are major bottlenecks when it comes to the biologic sector, the report says. Digital biomanufacturing has tech like monitoring real-time, data analytics, automation, and process optimisation. This is anticipated to help in the creation of a uniform process that can help in decreasing the quality deviation across every batch.

Lucrative opportunities are expected for the market players who offer bioprocessing 4.0 services because of access to real-time operations as well as rising interest in paperless manufacturing.