The demand for more environmentally friendly production of pharmaceuticals is growing, thus driving in turn the demand for alternative solutions to purify biopharmaceuticals, said the developer.
Bio-Works, which produces WorkBeads chromatography resins for purification of peptides, proteins, and other biomolecules, has been awarded a 250,000 SEK (€23K) grant from the EU's regional structure fund to develop a production method for chromatography resins that eliminates the use of fossil-fuel based solvents. The fund is part of the EU’s initiatives aimed at reducing the region’s carbon footprint.
“If the production of biological drugs is going to become climate neutral, a fossil-fuel free purification process is critical,” said Jonathan Royce, CEO at Bio-Works,
Purification with the help of chromatography resins is a step in the production of biological drugs which is critical to ensure that that the drug can be administered to patients. A new type of resin, based on fossil-fuel free raw materials, would significantly shrink the final product’s total carbon footprint. Today, there are no completely fossil-fuel free resins on the market, said Bio-Works.
The company is planning to execute the project next year, with the new production method expected to be implemented between 2024 and 2025.
Patent-pending process
Royce said that, traditionally, chromatography resins are produced either from polymers sourced from oil such as methacrylate or polystyrene or via an emulsification process in which a natural material like agarose or cellulose is emulsified in an oil phase that is sourced from fossil-based materials including toluene and xylene.
“At Bio-Works, we are developing a manufacturing method that uses natural materials (traditionally our resins are based on agar) but eliminates the need for the fossil-based materials. This process is patent-pending, and the patent application is not public yet, so we can’t reveal much more than this about the new process, but it significantly reduces the dependence on fossil-based solvents for the manufacture of resins," he told BioPharma-Reporter.
In addition to the EU grant, Royce outlined how the company is funding this sustainability focused project with its own finances. “We raised US$8.5m in capital in November 2021, and some of this money is being used to fund this important initiative.”
In terms of the assessment of the new environmentally friendly resins, the company will evidently evaluate the performance of the new product(s) against its existing portfolio of WorkBeads resins. But it will also look to collaboarate with customers in respect of such testing.
Looking to cost implications of such innovation, Royce said: “We believe that removing these materials from resin manufacturing processes will be cost-neutral to overall drug production costs but will at the same time provide significant environmental benefits which are realized by both Bio-Works and its customers.
"Many pharmaceutical companies have very specific climate impact goals, and the use of environmentally friendly alternatives can significantly contribute to achieving those goals.”
Critical gap between aspiration and action
A Deloitte report, Embedding environmental sustainability into pharma’s DNA, published in October, found that although pharma companies are adopting ambitious and measurable environment related goals and setting out a plan of action, the choice of targets, measurement of achievements and the pace of progress is variable. It outlined how there is often a critical gap between aspiration and action.
“To achieve their targets, companies need to take proactive steps to increase transparency and collaboration, establish and analyze extensive data sets to generate actionable insights and consider a radical reform of existing processes to deliver a bold, lasting transformation.
“The pharma industry will need to fundamentally reimagine existing drug development and manufacturing processes, business models, supply chains and digital infrastructure to collectively reach their commitments, and they need to do this now given the long development cycles. While pharma’s products in development are not for today’s market, but for the next decade and beyond, detailed consideration will also need to be given to the environmental footprint of products already in the market.”
