We might take for granted the multitude of medicines available to prevent, treat or cure diseases that may have previously cut our lives short. But behind every drug or vaccine is many years of painstaking research and development. It takes an average of 12 years to take an experimental medicine from the laboratory bench to the market [1].

While many medicines are derived from chemical compounds, biologics, derived from large and complex biological compounds, are now the fastest-growing class of drugs. They include products like vaccines, plasma-derived therapies, cell and gene therapies, and protein-based therapies, such as monoclonal antibodies.

Over the past five years, eight of the top ten best-selling drugs worldwide were biologics, with therapeutic antibodies becoming the principal class of new drugs developed [2]. By the end of 2020, the Food and Drug Administration (FDA) had approved more than 90 antibody-based drugs to treat a range of autoimmune conditions, infectious diseases, and cancers – and many more are in development [3].

“We’re seeing unprecedented market demand for these biotherapeutics globally,” says Merilee Whitney, Head of our BioContinuum^TM Platform. “There’s an incredible amount of growth in the number of molecules that are coming through the pipeline – and are also new classes of treatments, such as cell and gene therapies.”

Today, the biopharmaceutical industry is characterized by new market dynamics and drivers with a new paradigm emerging on how these complex biologics are efficiently developed and manufactured – to meet the increasing demands to deliver these complex drugs to patients as quickly as possible.  

Traditionally, the biopharma industry has largely relied on ‘batch processing’ to manufacture biologics. One facility is usually set up for the manufacture of a single drug through a stepwise process.

Although batch processing can reliably produce billions of doses of biological medicines, there is room to improve overall production efficiency. After each step along the manufacturing process, the material is ‘held’ and tested to make sure it is not contaminated – leading to a series of pauses during production. And the manufacture of the next batch must wait until the current one is complete.

“It can take upwards of 30 or 45 days to get to the final drug product using batch processing,” says Whitney. “As you’re progressing through the manufacturing process, your product is becoming more and more valuable and you’re having to wait until the final safety test, assuring that your medicine is safe to be injected into a patient before a batch can finally be released.”

“Drug manufacturers need to reduce their costs – and not just by 5-10%, but by 90% – which is the target set out by the industry,” continues Whitney. “At the same time, our customers are also looking to increase their flexibility so that they can produce multiple products within the same facility.”

To realize those ambitious goals, the industry is starting to shift away from traditional batch processing and is looking to increasingly adopt a new mode of operation referred to as “continuous bioprocessing”.

In contrast to batch processing, continuous processing aims to take a drug from its raw ingredients through to the final product without any interruptions. This removes the need to shut down equipment between batches and eliminates downtime, and is reducing cost.

“You can eliminate all those intermediate hold steps, which is the first huge benefit,” explains Whitney. “Furthermore, the current digital transformation of biopharmaceutical process development and manufacturing, also known as “Bioprocessing 4.0”, brings automation into drug manufacturing processes so you don’t have all these manual interventions for testing and monitoring, which not only saves a lot of time but also avoids the potential risk of errors and cross-contamination.”

The benefits are predicted to be highly significant.

“You’re shortening the overall time it takes to get the drug to market, from which patients benefit the most,” says Whitney. “But also from an industry perspective, it allows drug manufacturers to get better overall facility utilization, which will help them to meet increased demand and the need for greater flexibility in their facilities allowing them, for instance, to be better prepared for and able to more quickly respond to a global emergency – as we have all seen with the Covid-19 pandemic.”

But moving from batch to continuous to bioprocessing 4.0 is not straightforward. It’s an evolutionary journey across many disciplines. It will require several factors to come together to drive this transformation, as Whitney explains: “There has to be a lot more software and automation to help remove manual steps. There also needs to be the right data analytics – and a move away from traditional big shiny stainless-steel facilities, to smaller, more nimble, single-use facilities.”

Making this shift will not happen overnight.

“Where we are today is that our customers are facing bottlenecks in their processes in terms of the capacity of their facilities – and so we’re seeing this kind of stepwise evolution,” says Whitney. “In the next five to ten years, we’ll see more adoption of these convergent technologies that will get them closer and closer to fully continuous manufacturing and for some of our customers even to the facility of the future.”

The BioContinuum™ Platform represents our belief in and commitment to the evolution of bioprocessing.

“Whether developing an intensified, connected or continuous bioprocess, the BioContinuum™ Platform provides the process and digital building blocks to help our customers achieve their individual bioprocessing goals,” says Whitney.

This convergent offering and holistic, forward-looking view of biomanufacturing actively incorporates advanced processing, software, automation and analytic technologies across our portfolio to enable greater speed, flexibility and quality, empowering drug manufacturers to confidently enter the era of Bioprocessing 4.0 – making the facility of the future a reality.

“We’ve been working with our customers for decades side by side at the bench to develop their processes, help them scale them up, and take that into commercial manufacturing,” says Whitney. “And the breadth and depth of our offering provide another significant advantage – whether you’re looking at the cell lines and growth media, the systems, the consumables and services that are used to manufacture the drugs, or the software, analytical tools and automation components indispensable for better process insights and understanding allowing you to make better informed, data-driven decisions – we’ve got the entire portfolio from start to finish.”

The BioContinuum^TM Platform features next-generation technologies that provide incremental process benefits now, with a mind to the connected and continuous process of the future. For example, we recently launched our Bio4CTM Software Suite, which brings together advanced process systems with software, automation, and analytics into one ecosystem.

“This software allows our customers to aggregate, visualize and analyze their process data in a manufacturing environment in real-time,” says Whitney. “We’ve demonstrated that people can save hundreds of hours by implementing this software instead of having to manually gather data themselves.”

But our vision is to go beyond continuous manufacturing – to what we call “convergent bioprocessing”.

“What we’re driving is this convergence of advanced process technologies, software, automation, and analytics and how that all comes together seamlessly into an integrated process and ultimately into the facility of the future,” explains Whitney. “Many companies have people looking at the process technologies, then a separate team who is working on the software and automation – all in a very siloed and fragmented fashion. But instead, we’ve brought everyone together into one group – so we’re making sure that we’ve got this holistic perspective and that everything works together seamlessly right from the start.”

Although driving an evolution in bioprocessing is by no means an easy journey, the efforts are worthwhile as the potential rewards are huge.

“It’s all about getting those drugs and therapies to patients who desperately need them,” says Whitney. “And we are playing a key role in helping our customers achieve this – as quickly, efficiently, and as cost-effectively as possible.”

_{[1] https://www.medicinenet.com/script/main/art.asp?articlekey=9877
[2] https://jbiomedsci.biomedcentral.com/articles/10.1186/s12929-019-0592-z
[3] https://www.antibodysociety.org/resources/approved-antibodies/}