With the cost of manufacturing accounting for as much as 70% for cell and gene therapies, industry must look to bioprocessing efficiencies and collaboration, says Waters Corporation.
Waters Corporation is an analytical instruments, software, and service company. At the firm’s 2022 investor day last week, CEO Udit Batra spoke about the difference between producing small molecules, where “you get approval to produce a product with specific chemical and physical properties,” and the present biomanufacturing landscape, where the approval is for the process.¹
“Product is way better because then you can optimize the manufacturing process,” he told stakeholders, adding this is increasingly necessary as the cost of production comes under scrutiny by governments and payors.
In the early days of biologics, “the economic incentive was not there, and the technology did not exist,” he said. “How the world has changed in 25 years, especially with the arrival of cell and gene therapy.
“The challenge is it costs a lot to make it. The manufacturing cost is roughly 50% to 70% for a $1 million dose of these products on average – I’m talking $500,000 to $700,000 for a manufacturing process for a single patient. And the number one bottleneck to providing these therapies to many, many patients is the manufacturing process.
“Now that’s a problem worth solving. That’s a problem we want to solve. The proof of concept already exists. The technology has been developed to the point where we have BioAccord [a liquid chromatography-mass spectrometry (LC-MS) launched in January 2019]. We now need to make sure that we understand the process train of these complex biologics and take simple measurements downstream. That’s the ambition.”
He noted that mass spectrometry can now detect very large molecules. “Our technology has evolved from the small-end protein and small molecule size, the megadalton size, about 10 to the 6 Dalton, right up now to viruses and large molecules.”
But to further tackle biomanufacturing bottlenecks, Batra stressed the need to work in collaboration with others in academia and the industry. As an example, Waters is combining BioAccord with Sartorius’ Ambr multi-parallel bioreactor systems through a collaboration forged last September to accelerate speed and increase accuracy in bioprocessing analysis.
Meanwhile, Waters has just opened its second Immerse Lab: a collaboration with the University of Delaware that aims to give students, faculty, and industry researchers access to analytical technologies. The first such lab in Cambridge, Massachusetts also encourages academia and stakeholders to address biomanufacturing bottlenecks.
And as well as collaboration, Batra hinted at M&A activity aimed at addressing bioprocess bottlenecks. “We are going to collaborate with someone; We’re going to buy a company or two to advance the technologies […] and of course, we’re going to work on it organically.”
1 – Clarification: The original article stated the approval is for the product. This has been changed to process. A Waters spokesperson told us: “The FDA strictly controls changes to the manufacturing processes that evolve during the development of the biologic, as well as after licensing. Biologics are much more sensitive to process changes than are small molecule drugs – even a small change in the manufacturing process can result in an adverse change in the biological product.
“Changes to the biologic’s manufacturing process, equipment, facilities, or handling have the potential to affect the products identity, safety, purity, and potency. Therefore, any changes to production must be brought to the attention of the regulatory authorities, and the FDA will use its “comparability” ruler to determine if additional studies are required to support the license application.”