Global partnership to expand pharma biocatalysis uptake

Codexis, Inc. and Porton Pharma Solutions recently announced a strategic collaboration to deploy Codexis’ world-leading biocatalyst technology within Porton’s global custom intermediate and active pharmaceutical ingredients (API) development and manufacturing business. Dr Kevin Robinson caught up with Porton’s Oliver Ju and Codexis’ John Nicols to find our more

The partnership will accelerate the creation and commercialisation of new, low-cost, sustainable manufacturing processes, exploiting the benefits of biocatalysts to a growing number of the world’s small molecule pharmaceuticals.

Under the terms of the collaboration, Codexis will license core elements of its biocatalyst technologies to Porton, including its proprietary biocatalyst libraries, high-throughput screening and enzyme manufacturing know-how.

Codexis will also provide preferential access to its CodeEvolver protein engineering platform technology for the creation of new biocatalytic process solutions. Porton will install new operations to drive the adoption and optimal application of these biocatalyst technologies into its custom contract development and manufacturing (CDMO) offerings to global pharmaceutical customers.

Additionally, Porton has pledged financial commitments to utilise Codexis’ CodeEvolver protein engineering platform technology.

The partnership reinforces the benefits of reduced costs, enhanced sustainability and improved product quality that biocatalysts can deliver to the manufacturing of the world’s small molecule pharmaceuticals.

These benefits are already impacting a growing set of the world’s drug manufacturing processes and have earned Codexis three US EPA Presidential Green Chemistry Challenge awards for the contributions its biocatalysts have made in these commercial-scale drug manufacturing innovations.

“Technological leadership is central to our strategy to grow and deliver value to our pharmaceutical clients around the globe,” said Oliver Ju, Chairman and CEO at Porton Pharma Solutions. “We believe that biocatalysis is the most impactful technology to improve the future of pharmaceutical manufacturing … and there is not a more capable player to partner with than Codexis.”

Adding some background, Oliver commented: “Porton was established in 2005 as a China-listed CDMO, which now boasts more than 1700 customer-centric employees and three manufacturing sites in the country. We also have two sites in New Jersey, in the US, where we employ 70 process chemists. We’re hoping to increase that number to about 120 personnel during the next 2–3 years and become one of the largest process chemistry organisations in America.”

“As an industry leading partner and provider of custom active pharmaceutical ingredient (API) development and manufacturing services to the global drug industry, we’re bringing significant resources and capabilities in solid dosage form expertise to the partnership,” he added: “Our revenue is at the $200 million level and, now, having rebranded to Porton Pharma Solutions, we’re very focused on small molecule API, late-phase development and commercialisation.”

With respect to the new collaboration, Oliver recognised a need to “become more global to better serve present and future customers in our major markets of Europe and China.” He also emphasised the creation of an end-to-end service model, from early stage development up to Phase I and beyond.

“To do that,” he said, “from both a business and technology point of view, we needed to be more innovative; we believe this partnership will give us fast-track entry into the world of biocatalysts, which is something we can now add to our post-discovery pharma service offering.”

He concluded: “For Porton, we feel that the next 5–10 years will be a very exciting time and a period of substantial growth. Through this new, strategic collaboration, we’re on the right path to becoming a truly global leader in our field and creating additional value for our pharmaceutical clients.”

“We are delighted to establish this unique partnership with Porton,” said John Nicols, President and CEO of Codexis. “Given Porton’s significant and fast-growing presence as a leading global CDMO, we will now be able to reach a greater share of the world’s pharmaceutical manufacturing market.”

Codexis is a leading protein engineering company that applies its proprietary CodeEvolver technology to develop proteins for a variety of applications, including as biocatalysts for the commercial manufacture of pharmaceuticals, fine chemicals and industrial enzymes, and enzymes as biotherapeutics and for use in molecular diagnostics. Codexis’ proven technology enables improvements in protein performance, meeting customer needs for rapid, cost-effective and sustainable manufacturing in multiple commercial-scale implementations of biocatalytic processes.

Shifting the paradigm

“We believe that one in three small molecule drugs could be made cheaper if a biocatalyst was customised for each of those API processes. We’re nowhere near that level of adoption and, so, we started to challenge ourselves and ask: why aren’t we accelerating the uptake of this technology? Already, we’ve had some incredible success stories and significantly transformed a good number of manufacturing processes. But, we realised that we really only had the bandwidth to promote and drive Big Pharma clients to understand and use the technology, and our historical efforts to work with CDMOs hadn’t been overly successful … until we met Porton,” explained John.

“What we realised,” said John, “was that our control of the technology was slowing us down; we kept all the enzyme libraries in house, we didn’t do enough enzyme assessment and screening training, etc. So, with this arrangement, we’ve broken through those barriers and found a very progressive partner who clearly values the technology as a way to advance in the industry.”

With access to a huge library of enzyme products and the ability to do high-throughput screening, Porton will be able to assess, install and implement Codexis enzyme “solutions very quickly and efficiently. “Eventually able to create their own enzymes, we’re essentially cutting out their need for us,” summarised John, “which will make them quicker and more knowledgeable, and us — as partners — in a much more competitive position in the market.”

A key benefit, adds John, is the removal of hurdles such as very little awareness and adoption. “The CDMO world controls a substantial amount of pharmaceutical manufacturing … and we had a zero per cent stake in that. So, either we had to change or simply limit our ability to grow. We had to find a partner we could trust, establish a very special relationship and unlock as much financial potential as possible.”

Beyond pharma

Asked whether the service was limited to the drug manufacturing sector, Oliver comments that, during the first phase of the relationship, the key focus is pharma. “But,” he adds, “there is great potential — particularly in the Far East — for industrial enzymes in detergents. With our chemical process innovation, rapid scale-up and high-quality, cost-effective manufacturing solutions in China, we can certainly help Codexis to gain a foothold in this promising market.”

John adds: “That’s very much a growth sector for us and we’re already able to get some of our proteins into some of the classic industrial enzyme markets. The food space currently represents 10% of our sales and we’re also launching enzymes into molecular biology/diagnostic applications such as next-generation sequencing or PCR workflows.”

The end game is to get drugs to market in a quicker and more cost-effective way using the best process.

“Working together, we’ll now get more objective, real-time evidence to assess whether biocatalysis is the most economic route to market (taking into account the cost of customising the enzyme).”

As an aside, John mentions that a small team can now produce a tailor-made enzyme in 2–3 months.

In conclusion, Oliver notes: “Within the partnership, we can create new, more cost-effective biocatalyst offerings. We can use our position as a low-cost manufacturer to providing the enzyme on site and make biocatalysis a much more competitive route to market than traditional chemical methods.”

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