Leading immunologist and director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), Dr Anthony Fauci, has noted that the pandemic era is upon us with disease outbreaks becoming more prevalent in our increasingly globalised society. With epidemics becoming the new norm, the biomedical sector will play an outsize role in creating a more sustainable society that can accommodate population growth.
While we have seen good progress on vaccine candidates around the world, much of the emphasis has been placed on the discovery process of a vaccine or cure; in short, the research and development aspect. However, governments and scientists have already started worrying about the next big hurdle – meeting the volume required.
Roadblocks in the journey to recovery
Even before the recent need for the mass manufacture of a vaccine at an unprecedented speed, biomanufacturers have already been facing several challenges:
The increasing complexity of global supply chains mean that manufacturing common biologics such as insulin requires hundreds of different components –microbes, testing equipment, sterilisation labs and more – to be activated from across all corners of the world.
Severe disruption caused by border controls and lockdowns emphasise the difficulty manufacturers have in managing, monitoring, and accounting for a rapidly expanding supply-chain network.
- Fluctuating demand
The spike in demand for ventilators, personal protective equipment (PPE), and even hand sanitisers are all indicative of the scenario in which a successful vaccine candidate obtains regulatory approvals.
Medical manufacturing plants are already at maximum capacity and industry players are understandably cautious when making expansion plans due to the significant investment and low visibility on future demand patterns.
- The rise of the remote workforce
Biomanufacturers are taking a double hit in the current crisis – not only is there tremendous pressure to increase production volumes, but social distancing requirements to ensure staff safety have disrupted daily operations.
Staggered shifts and venue capacity limitations impede efficiency but are necessary. Should a single production line employee be infected the entire shift is required to self-isolate. The company may then need to rapidly onboard a new team; one that might be unfamiliar with the processes.
- Quality controls
The damage done by product recalls extend far beyond the logistical process. Contamination occurring in the manufacturing process sustains the financial burdens of deep-cleaning machinery, investigations, potential lawsuits, as well as tarnish brand reputation which can hinder a company’s very license to operate. Quality control, health and safety standards are never more under the microscope than during a pandemic.
Johnson & Johnson famously spent more than US$260 million to recall 31 million bottles of Tylenol capsules and re-establish the brand. More recently, it has been estimated that over half the batches of injectable drugs produced were thrown out because of quality issues, such as bacterial contamination and industrial particulate impurities.
High-tech solutions for high-stakes situations
With over seven billion lives at stake, improving the speed and efficiency of vaccine manufacturing cannot compromise safety and quality standards. In anticipation of the unprecedented demand of a single product, biomanufacturers can look to incorporate next-generation technologies.
- Distributed Control Systems (DCS)
Time is indeed of the essence as speed-to-market becomes a prime concern for manufacturers as product moves further along the pipeline from discovery through clinical trials.
Making laboratory and pilot plant data easily accessible to digital automation systems is essential to accelerate commercial production. A modern DCS can be integrated into legacy software and right-sized to create completely integrated plant-floor solutions as well as analyse raw data to operational and equipment efficiency.
More critically, DCS provide an end-to-end manufacturing solution that lay the foundation for Electronic Batch Records (EBR), validation, and regulatory compliance.
- Electronic Batch Records
EBR systems replace hardcopy workflows with computer-based workflows, reducing the risk of human error and speeding up compliance processes.
EBR systems can do more than just bookkeep. When integrated into a connected factory ecosystem, they can access enterprise-wide information, deliver role-based instruction to workers, provide exception-based reporting, improve batch accuracy and consistency, speed time-to-market, and reduce overhead costs. In the near future, serialisation will become a consistent requirement along with other information about the item, including manufacturer and batch details. EBR systems enable manufacturers to digitally verify and authenticate products against their database at every step in the distribution chain, from the factory to the consumer.
As social distancing measures persist, EBR systems can be connected to mobile devices, giving workers access to information anywhere on the plant floor.
- Augmented Reality
Augmented Reality (AR) and advanced simulation tools capture manual activities in a virtual environment, enabling rapid knowledge transfer that can reduce training time and bridge gaps in expertise with recently redeployed teams.
AR allows remote experts to help onsite personnel perform the critical tasks and maintenance required to recover from unplanned downtime situations. For example, equipment-manufacturer intelligence can be streamed directly to an engineer’s device, even as maintenance staff at other plants help with the diagnosis.
Mixed reality devices also help frontline employees to safety assemble complex products, by equipping them with real-time production data and instructions as required while performing the task. Simulation tools enable engineers to map equipment layouts and study the impact layout changes have on productivity and throughput.
Machine builders can monitor installed bases of equipment from anywhere in the world via VR viewing a digital twin of the entire production process. By analysing real time data from machinery, they can alert customers to maintenance requirements and warranty renewals.
- Independent Cart Technology
Independent Cart Technology (ICT) addresses most shortcomings legacy conveyance systems have; synchronous, fixed transport systems limited to processing stations in a single direction with a preconfigured path at a fixed speed.
ICT deploys linear motor technology for the end-to-end configuration of conveyor modules, creating an electromagnetic force that propels product carriers at a faster speed. Even better, modular ICT carriers operate independently; each fully configurable to accommodate process, assembly and size variations.
A bonus for biomanufacturers is that ICT creates a high-fidelity track and trace record that streamlines validation and compliance.
The age of automation
Even before COVID-19, the global market for bioprocess optimisation and digital biomanufacturing was estimated to reach US$40.5 billion by 2023. It is time for biomanufacturers to embrace the age of the smart industrial plant, converging operations and IT to connect people, processes, and devices under a seamless unified infrastructure.
The pharmaceutical industry is synonymous with innovation and it’s time we applied the same mindset to its manufacturing aspect. Digital transformation is a long-term investment that future-proofs a business. It enables the collation and analyses of big data, helping companies reduce overhead costs and make numerically-driven decisions to predict and capitalise on potential market demand.
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