The biologics processing and manufacturing industry is experiencing a big data and digital revolution. The digitalization of the biomolecular manufacturing process has created immense opportunities for businesses to incorporate data management, analytics, modeling, automation, machine learning, and other AI tools into their manufacturing processes to optimize them.
Currently, these digital tools are being used to improve process robustness and product quality in areas like supply chain, operations, quality, clinical development, process development, and manufacturing of life sciences and pharmaceutical products.
By utilizing parameters such as equipment health and real-time process updates, digital biomanufacturing makes it easier to optimize manufacturing processes. Software for digital biomanufacturing boosts asset availability and dependability while lowering maintenance needs.
By integrating technology into equipment through digital biomanufacturing 4.0, applications like raw material analysis and predictive maintenance can also be facilitated in the system.
The Agency for Science, Technology, and Research claims that digital biomanufacturing streamlines the biomanufacturing process by integrating physical assets with digital technologies. The digital transformation of biopharmaceutical process development is known as Bioprocessing 4.0.
Currently, the bio manufacturers are facing immense pressure to increase productivity delivery and marketing biotherapeutics at a faster pace. Due to the outdated and inefficient paper-based processes, 70% of collected biomanufacturing data remains unused. Eventually, this leads to data loss and contributes to long turn-around time and high costs of biologics drug development.
Hence, the pharmaceutical and life sciences industry is working toward an end-to-end process in which all systems will be digitally enabled and connected to optimize and reinvent their operations while enabling an accessible supply of drugs and inexpensive treatments. These facilities are a component of Bioprocessing 4.0, a new phase in biomanufacturing that is based on automation, software integration, and digitalization.
According to a recent study conducted by BIS Research, the global digital biomanufacturing market was valued at $15.9 billion in 2021 and is expected to reach $55.9 billion by the end of 2031. The market is expected to grow at a CAGR of 13.12% during the forecast period of 2022-2031.
The Bioprocessing 4.0 movement has given the biomanufacturing industry the potential to modernize its manufacturing processes and align them with the latest industrial revolution. Managers and process engineers are both interested in converting their plants into smart manufacturing facilities because of the promise of enhanced productivity and flexibility. A few of these developments in the digital biomanufacturing industry are discussed further in this article.
Rockwell Automation and Cytiva Bring Digital Operations to their Pharmaceutical Development Center
On June 22, 2022, Rockwell Automation, the world’s largest company dedicated to industrial automation and digital transformation, announced its advanced digitalized life sciences production solutions that are expected to play a key role in an innovative pharmaceutical development center in Uppsala, Sweden.
To advance the growth of the life sciences industry and its production skills, the Testa Center was founded in 2018. It is a partnership between the Swedish government and Cytiva, a major life sciences supplier on the international stage. This partnership has supported Rockwell and Cytiva's long-standing collaboration and their joint work on automation in the biomanufacturing sector since 2019.
To illustrate, assist, and expedite the industry's digital transformation, Rockwell Automation and Cytiva have developed a powerful, flexible, and scalable platform that combines their expertise in biomanufacturing and automation.
The companies are investigating ways of using the Industrial Internet of Things (IIoT), Augmented Reality (AR), and other cutting-edge technologies for connectivity across the production process. An Automation and Digital Transformation Center has also been established in Shanghai by Rockwell Automation. With cutting-edge factory field management solutions under development, Rockwell Automation and Cytiva are paving the way to a bright future of digital solutions for biopharmaceutical companies. These solutions will improve operator efficiency and training, accelerate batch review, simplify equipment management, and increase productivity.
According to Sa Arvidsson, vice president of Rockwell Automation's EMEA North region, "Adaptability and scalability are the fundamental components of any modern life sciences business. Manufacturers require the flexibility to design, test, enhance, and manufacture at a significantly faster speed than ever before as individualized therapies, single-use skids, and rapid-development programs have become widespread. Only digitalized process and automation systems created expressly with pharma demands in mind can accomplish this effectively”.
An Attempt to Develop Sustainable and Green Biomanufacturing Design
The biopharma sector sometimes experiences a difficult time in achieving its goal of green, sustainable biomanufacturing. Thus, bio manufacturers are starting to advance sustainability by investing in resources to understand the issues regarding the same.
Bio manufacturers have realized that being green can result in financial savings. According to William Whitford, life sciences strategic solutions leader at DPS Group Global, many actions that led to bioprocess intensification started to save money and time, which in turn lowered environmental load per kilo of product. For instance, adopting big volume or high-density cryopreservation (preservation of cells by subjection to extremely low temperatures) lowers the quantity of plastic trash produced per kilogram of product. Additionally, using modern digital inventory management can lessen the amount of single-use system (SUS) goods that are thrown away after their expiration date.
However, environmental burdens are not always visible, and removing one burden might lead to the creation of another. Thus, Whitford says, “Changes should be evaluated holistically to consider both their overall and life cycle effects. Water for injection (WFI) and bioreactor clean/steam energy, single-use (plastic) systems, spent media, and the substantial shipping and packing for single-use systems are only a few examples of the hidden burdens.”
Whitford, along with his colleagues Daniel Jones and Sean Kinnane, recommends lowering energy and water usage, the production of solid waste, and implementing more effective and sustainable materials, processes, and recycling layouts. Choosing the materials and methods to use should be the subject of careful analysis, such as life cycle evaluation.
Moving Closer to Real-Time Biomanufacturing Analytics
Two fresh technologies for quick bioprocess analysis have been created by a team of British experts. The University College London team has created a "viral laser" and an unnamed system for almost real-time product and impurity monitoring.
As an alternative to ELISA, a widely used test for measuring soluble molecules, including proteins and antibodies, the viral laser technique is a ligand-binding assay. The goal of the researchers is to create a collection of biorecognition probes that can connect to the target molecules while simultaneously producing a laser field. The first probe, hence the term viral laser, was a dye-labeled M13 bacteriophage.
According to John Hales, a research fellow from the department of biochemical engineering, “The ligand-binding assay could rapidly report on the concentrations of product or impurities through laser concentration, ideally working at-line to the bioprocess”.
In 2020, Hales was awarded a $14.40 million U.K. Research and Innovation Future Leaders Fellowship to work on the virus laser.
The second innovation, which is still unnamed, intends to quantify proteins in mixtures in real time without the need for labels. For instance, when proteins co-elute from chromatography columns.
The system uses a short-pulse nanosecond laser with UV emission at a wavelength of 266 nm. The pulse is directed toward a capillary, such as one in which proteins are exiting a chromatography column, in which the proteins are flowing.
The proteins get activated, and an ellipsoidal reflector and a photodiode then record the fluorescence of the activated proteins. The research team then digitizes the signal using a sampling oscilloscope and applies data-processing techniques, such as protein identification, to the signal.
Conclusion
A new generation of automated smart biomanufacturing laboratories is revolutionizing the biomanufacturing sector as global demand for bio-based products and resources grows. Conventionally, metabolic engineering projects were carried out by hand, with a lot of trial and error involved.
Hence, the biomanufacturing sector has the chance to modernize its production processes in order to keep up with the latest industrial revolution.
