Scientist at The Heath signs agreement with world-leading Swiss biotech company to commercialise groundbreaking peptide

A scientist operating from laboratories at The Heath Business and Technical Park has made a ground-breaking discovery in the manufacturing process for peptides which are crucial for modern medicine as an essential ingredient for numerous drugs.

Peptides currently synthesized using toxic organic solvents pose safety and environmental problems but research and development by Dr Don Wellings, Managing Director of Runcorn bioscience company SpheriTech and his team, has produced water-based solid-phase peptide synthesis (SPPS) to reduce safety and ecological impact.

Dr Wellings explains: “Over recent years there has been a dramatic surge in the number of peptide drugs approved for human use. Between 2016 and 2023 out of 370 new drugs approved 31 were peptides. The recent approvals of the peptides Semaglutide and Tirzepatide for treatment of obesity open the floodgates for development of new peptide drugs. Clearly, due to the prevalence of obesity in our modern society the demand for these peptide drugs is going to be phenomenal.
“However, the current manufacturing processes are not capable of supporting the forecasted requirements for the supply of these peptide drugs, so a major change has to be made. The majority of peptide drugs are manufactured by SPPS using Fmoc-amino acid based chemistry. The SPPS process uses large quantities of toxic solvents such as N,N-dimethylformamide (DMF). REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulations recently changed the classification of DMF due to its safety profile and environmental concern, so it is now even more difficult to transport and use DMF.”

Dr Wellings says alternative solvents are also now under similar review: “The problem to-date lies in the fact that Fmoc-amino acids have required organic solvents for dissolution. Fmoc-amino acid based chemistry is well established and has dominated the industry for over 45 years. There is now a trend to move towards ‘green chemistry’ choosing solvents with lower toxicity and less environmental impact. However, with numerous groups worldwide working on the problem, nobody has come up with a solution.”
Now SpheriTech’s ground-breaking research is set to be a gamechanger for the industry.
Dr Wellings recalls his ‘Eureka moment’ came on March 8th, 2023, when he discovered a way to dissolve Fmoc-amino acids in water.
He says: “This was as much a shock to me as it still is to my colleagues, fellow scientists and collaborators. The first time I managed to dissolve an Fmoc-amino acid in water on that day in March 2023 I took a photo of it and sent it to a great friend and colleague of almost 40 years, Professor John Wade of the Florey Institute at the University of Melbourne. John Wade is one of the most experienced peptide chemists in the world and sits on SpheriTech’s scientific advisory board along with one of the co-inventors of Fmoc-amino acid based SPPS, Dr Eric Atherton. John was of course equally amazed.
“This is one of the most important discoveries in peptide synthesis for over four decades, so it was essential that we developed the technology further and checked for limitations.”

Dr Wellings and his team immediately set about investigating the potential to carry out Fmoc-amino acid based peptide synthesis in water by the SPPS process and confirmed the potential of his research.
SpheriTech has now entered an agreement with biotech company Bachem AG (Switzerland), who are world leaders in the sector, to commercialise the process.
Bachem says the demand for peptide-based drugs grows, finding sustainable alternatives becomes imperative in an industry that must secure the long-term supply of medical ingredients for millions of patients worldwide. A growing pipeline of clinical projects, including a new generation of medicines against diabetes and obesity, all based on peptides, and combined with tightening environmental regulatory trends, are expected to challenge the current large scale use of solvents approach in the decade to come.
Dr Wellings says: “Since the initial breakthrough we have continued to develop a process for Fmoc-amino acid based peptide synthesis in water over the last 18 months to a stage where we have now demonstrated a robust process which has the potential to be scaled to industrial levels within a very short period of 2-3 years.”
He says that DMF and other toxic and environmentally damaging solvents are not used in SpheriTech’s manufacturing process with peptides now assembled in water on a novel inexpensive solid support also invented and developed at SpheriTech’s laboratory at The Heath.
Dr Wellings adds: “Ultimately, 3-4 patents will be generated from the work we have done on water based peptide synthesis at SpheriTech securing our position as leading innovators in peptide synthesis. Further work yet to be published will confirm that we have the only viable way forward for industrial scale manufacture of peptides.”
John Lewis MBE, Managing Director of SOG Group which owns and operates The Heath Business and Technical Park, said: “This is fantastic news for Don Wellings and SpheriTech. It is yet another example of the marvellous and very innovative research and development being undertaken by the many science businesses operating in the laboratories at The Heath.”

For further information on SpheriTech go to:
https://www.spheritech.com

About The Heath
The Heath Business and Technical Park is a phenomenal regeneration success story. Formed in 2000, its owner and operator, SOG Ltd, has transformed a once single occupancy corporate facility into a thriving independent business park. The Heath now provides office and laboratory accommodation for more than 120 individual organisations, ranging from business services and IT specialists to those at the cutting edge of science, research and advanced manufacturing. Around 2,000 people are employed at the site. For further information, telephone 01928 515988 or visit www.theheath.com

For more information, please see:
www.theheath.com

PAUL SMITH ASSOCIATES
22nd August 2024