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article imageQ&A: Advantages of continuous manufacturing for pharma Special

By Tim Sandle     Jan 20, 2020 in Business
Continuous manufacturing forms part of the industry 4.0 paradigm, and following success in other sectors this approach is being applied to pharmaceuticals (moving from "batch manufacturing" to "continuous manufacturing").
The company Debut Bio has announced their seed funding of $2.6 million, with KdT Ventures leading. The round was oversubscribed and included participation from Better Ventures, FTW Ventures, and SpringTide Ventures.
Debut Bio helps the pharmaceutical and specialty chemical industries manufacture high value molecules by combining custom-designed immobilized enzymes with continuous biomanufacturing processes. The company’s cell-free platform has the ability to transform low-value bio-renewable materials (like glucose) into high value therapeutics and specialty chemicals.
To learn about the approach, Digital Journal caught up with CEO Joshua Britton.
Digital Journal: How was Debut Bio formed?
Joshua Britton: As chemists, we truly understood first-hand how hard it is to create products found in nature (called natural products). Yet how we develop natural products hasn’t changed much in the last 70 years.
Debut Bio was formed when our founding team saw the potential of enzymes in cell-free systems to create complex pharmaceuticals in ways that chemists could only dream of. Enzyme pathways and evolved proteins hold the key.
After filing two patents at the University of California, Irvine, we decided to license the technology we developed after years of research and commercialize the use of complex enzymes for the industrial creation of therapeutics and specialty chemicals. We officially founded the company in May, 2019.
DJ: How does Debut Bio assist the pharmaceutical sector?
Britton: The grand challenge of the twenty-first century is the transition to greener, more sustainable manufacturing processes that efficiently use raw materials, eliminate waste, and avoid the use of toxic and hazardous substances. At present, the pharmaceutical industry relies on a production process known as batch manufacturing that has remained the status quo for 75+ years. This lengthy step-by-step “chemical vat” process often requires the use of oil products, scarce metals, and costly intermediates. In short, batch is dirty, slow, and expensive. In fact, it is estimated that the pharmaceutical industry alone wastes nearly $50bn per year on inefficient batch manufacturing processes. To remain competitive, many incumbent manufacturers are interested in partnerships that will allow them to transition to bio-based chemical production.
At Debut Biotechnology, we offer customer validated, patented, and scalable solutions that help shift our partners away from batch manufacturing toward more sustainable, clean, and cost-effective methods of production. Our core technology relies on the combination of immobilized enzymes with continuous manufacturing in a cell-free environment. By immobilizing enzymes and readying them for continuous manufacturing via plug and play cartridges, we can achieve a wide variety of benefits over incumbent batch chemical synthesis.
At its core, we create therapeutic molecules in a faster and cheaper manner while avoiding toxic metals and resultant waste streams. Nature has evolved enzymes for millions of years to perform bio-transformations to exacting specifications in a green and sustainable manner. To that end, we’ve created a platform for cell free biocatalysis utilizing immobilized enzymes and continuous flow chemistry to help our customers re-think the way they perform chemical synthesis.
By leveraging Debut Biotech's platform, pharmaceutical companies will no longer have to perform long and tedious syntheses when they want to create complex pharmaceuticals that resemble the molecules found in Nature. Instead, they can simply use our enzyme-based system to turn low-value materials, such as glucose, into high-value therapeutics and intermediates in a sustainable manner. When companies want to get the exact molecules found in Nature with therapeutic benefits, they can again use our technology platform. As Debut Bio advances, we expect our platform capabilities to broaden to a large number of small molecule therapeutics that will allow quick, green, and cost-effective access to these value-added molecules.
DJ: What is continuous manufacturing and what are the advantages?
Britton: In continuous manufacturing, a pump (or pumps) continuously passes a low value reactant solution through a reactor in which it is transformed. In our case, the reactor contains a large number of complex immobilized enzymes. After a set amount of time, the product exits the reactor and is collected. Continuous manufacturing often provides improved enzyme stability, reaction rates, selectivity, lifetime, and efficiency to cell-free systems, yet no continuous cell-free system exists. In general, continuous manufacturing is the distinct opposite to batch manufacturing.
In batch manufacturing, a reaction is started, it is run for a certain amount of time, and then the reaction is stopped. Then, the product is isolated and the whole process starts again. In continuous manufacturing, a solution is continuously passed through a reactor. As the solution enters one side of the reactor and then exits, it is transformed. In this sense, the reaction can run indefinitely and through a smaller infrastructure. Additionally, continuous manufacturing allows for quicker reaction times and better control, as well as the potential for analytical technology to follow the reaction in real time.
DJ: Which types of companies and processes are you helping to develop?
Britton: We are helping the pharmaceutical and specialty chemical industries manufacture high-value molecules
DJ: What is your latest news relating to seed funding?
Britton: On January 7th, we were extremely excited to announce the close of our $2.6M seed round. The oversubscribed round was led by KdT Ventures, with participation from Better Ventures, FTW Ventures, and SpringTide Ventures.
DJ: What will be your next phase of development?
Britton: Currently, we are already working with two large manufacturers to integrate the Debut Bio platform into their existing pipelines and processes. Looking forward, we're excited to continue our commercialization efforts of an automated and reconfigurable continuous manufacturing system for the production of therapeutics using in vitro enzyme pathways.
More about continuous manufacturing, batch manufacturing, Manufacturing, Pharmaceuticals
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