Speaking at the ‘Innovative Chemistry for Peptide Manufacturing and Analysis’
conference, SB3000’s Chief R&D Officer Jens Bukrinski revealed that continuous manufacturing μLOT® technology could reduce the pharmaceutical industry’s use of toxic chemicals by 100 times.
Batch manufacturing has long been the standard for peptide pharmaceutical manufacturing, but it is hugely inefficient, requiring massive facilities and vast quantities of toxic raw materials. Peptide manufacture is also one of the most wasteful and least green chemical processes, and peptide synthesis is almost universally carried out in toxic solvents[i]. Typically, over 4000kg of toxic solvents are required to produce just one kilo of drug.
In contrast, innovative μLOT® continuous manufacturing enabling technology uses a chemical production line which can be constantly monitored in real time, uses just a tenth of the solvent required in batch processing and being modular is easily moved.
The FDA is actively encouraging a move to Continuous Manufacturing in the pharma industry. It has recognised that continuous manufacturing will reduce drug shortages, minimise batch manufacturing scale-up issues, and enable shorter process times, improve quality control, generate smaller footprints, and increased flexibility in scale[ii].
Jens commented during his presentation to the virtual ‘Innovative Chemistry for Peptide Manufacturing and Analysis’ conference, “μLOT® allows for continuous manufacturing of peptides at large scale, with hugely reduced environmental impact. For example, liraglutideiii is currently manufactured as a recombinant peptide in yeast. If manufactured synthetically with current batch SPPS it would generate 16,000 tons of toxic waste per year. Switching to continuous manufacturing using μLOT® would cut toxic waste by 100 times to just 160 tons toxic waste per year.”
He concluded, “As pressure mounts on the pharmaceutical industry to cut its use of toxic chemicals, the case for adopting μLOT® continuous manufacturing become indisputable.”
SB3000 is already engaged with a top ten pharma and working with a speciality pharma and the biotech Evaxion.
iiiliraglutide - brand name Victoza for the treatment of type2 diabetes – annual sales around $3 billion
25th February 2021
- μLOT® technology could reduce environmental impact of peptide medicine production by 100-fold.- μLOT® will provide an unprecedented quality control throughout the production process
SB3000 ApS solid phase, continuous manufacturing enabling technology has been awarded an Innobooster grant by the Danish Innovation Fund to further refine its ground-breaking technology and dramatically reduce the environmental impact of medicine production. SB3000 is initially focussed on peptide medicines where the existing batch process, on average, requires 4000 kgs of toxic solvents to produce one kilogram of medicine. Currently, about 1500 kg of commercial peptide is produced annually leading to use of >6million kgs of toxic solvent. This is obviously not a sustainable approach in the future.
The patented μLOT® technology is the world’s first enabling solid phase, continuous manufacturing technology to produce solid peptide synthesis of all sizes of peptides. The advanced technology includes a specially developed ribbon which incorporates sachets of resin. The ribbon which winds its way through the various stages of production is constantly monitored for quality doing away with the need for a quality assessment control centre at the end of the production line used in batch processing. In batch production up to 15% of all batches must be discarded due to quality issues. This is extremely costly involving the loss of millions of dollars of product and the costs involved in disposing of the toxic waste.
Zsolt Lavotha CEO of SB3000 commented, “We are pleased to have been awarded the Danish Innovation grant which is a recognition of the environmental benefits our technology will provide. This grant will enable us to further develop the μLOT® technology and the many benefits it brings to our clients in pharma and contract manufacturing. These benefits not only include dramatically reducing negative environmental impact and increasing quality, but also reducing capex by 50% and providing a flexible process which can be used for different medicines and which is easily transportable for on-shore production.”
The grant application was developed together with Innovayt, a European innovation finance consultancy who SB3000 partnered with on their soft funding strategy. Thomas Elmbæk Knudsen partner at Innovayt commented, “This was an extremely rewarding project as SB3000’s technology is truly innovative and could change manufacturing technology not only in pharma but in many other industries. “
SB3000, which has a research agreement with a large international pharmaceutical company and is in advanced stages of negotiations on a commercial agreement with a large European specialty pharma, is currently in it’s Series B financing round raising EUR13M to bring the μLOT® technology to the wider market.
20th July 2020
Zsolt Lavotha has been appointed acting CEO of Swedish Biomimetics 3000 Ltd (SB3000 Ltd), a pioneer in green, continuous manufacturing of pharmaceutical products.
Zsolt has extensive experience in healthcare in both large pharma and biotech including senior global positions in Wyeth and Pfizer, CEO of Orexo and Lavipharm. Zsolt will be taking day to day control of the technical teams who are based in Norfolk UK, Lund Sweden and Copenhagen Denmark and will lead the ongoing partnership programmes with a variety of organisations including major pharma and contract manufacturers.
This follows the resignation of Andreas Segerros, who is joining a life sciences focused venture fund. A search for a new CEO has been initiated.
12th March 2021
SB3000's Chief R&D Officer, Jens Bukrinski, will be speaking about µLOT® technology at the 'Innovative Chemistry for Peptide Manufacturing and Analysis' conference on Wednesday 17th March 2021.
The online conference is free to attend via this sign-up link: https://www.teknoscienze.com/webinars/innovative-c...
21st October 2020
- SB3000’s patented, continuous manufacturing technology μLOT® may be used to accelerate manufacturing development and rapidly deployed for large scale commercial production
- Because μLOT® enabled facilities are modular and a fraction of the size of traditional batch facilities they have the potential to be easily transported to sites around the world.
Evaxion Biotech A/S has received funding from the Danish Innovation Fund to further develop their AI platform RAVEN to rapidly respond against future corona virus pandemics - from initial discovery to first in human trials in as little as 13 weeks. During those 13 weeks SB3000 intends to develop and validate a tailored μLOT® continuous manufacturing process for the vaccine at commercial scale. Being modular and easily transportable the μLOT® enabled production units can be deployed to sites across the world.
Evaxion believes that by combining its structural design tools and prediction algorithms, RAVEN (Rapidly Adaptive Viral Response) will be able to develop a vaccine design that induces both a T and B–cell response. The main aim of the RAVEN platform is to respond rapidly to future emerging viral pandemics, and intends to target the virus behind COVID-19 as a proof of concept in animal models.
Lars Wegner CEO of Evaxion commented, “We believe that it requires high levels of innovation to design and develop a new vaccine very rapidly and we intend to harvest the full potential of our RAVEN AI technology platform. To do this we will be combining it with an equally innovative manufacturing technology to tackle the production bottleneck of current manufacturing technologies to rapidly scale up commercial production. We expect that the SB3000 μLOT® technology for continuous manufacturing of peptides will allow us to accelerate design, development and supply. The manufacturing process will be developed at scale during pre-clinical studies and, upon validation, we expect that this method will be scaled out and moved straight into commercial production with no further development required, at a fraction of the traditional manufacturing cost.”
“We believe that one of the most important benefits of this technology is that a manufacturing facility enabled by μLOT® can be easily set up or relocated due to its modular design. We believe that this is becoming particularly important as more and more countries see securing internal supply of essential medicines as a key strategic element of a nation’s security,” says Head of R&D of SB3000 Jens Bukrinski
SB3000 has been developing the μLOT® technology for some years and in addition to this agreement with Evaxion, SB3000 has a research agreement with, a large international pharmaceutical company, and is in the advanced stages of negotiations on a commercial production agreement with a large European specialty pharmaceutical company.
Zsolt Lavotha CEO of SB3000 commented, “We are delighted to be working with Evaxion, which we believe to be a leader in bringing rapid advances in the discovery and design of potential new treatments through their proprietary AI technology platforms. The COVID-19 pandemic has shown the importance of not only the rapid discovery of new treatments, but also the importance of getting these treatments to patients around the world.”
16th September 2020
Swedish Biomimetics 3000 Ltd, a life science technology company which has developed a world leading green technology platform used in the continuous manufacturing of pharmaceuticals, has established a new head office and scientific research facilities in Copenhagen. The company, which is called Swedish Biomimetics 3000 ApS, believes that it will benefit from the sector specific expertise in Denmark in expanding its capabilities. Going forward, the company will have key operations in both the UK and Denmark.
SB3000 ApS is initially focused on replacing traditional batch manufacturing in the production of peptide medicines, which are particularly expensive and environmentally damaging to produce and are holding back research into the development of new medicines. The company, has recently signed a research agreement with a top-ten global pharma company and obtained a letter of intent from a top EU based specialty pharma company which has initiated negotiations on a commercial agreement.
There is huge pressure by both regulatory authorities such as the FDA and international agreements to move to continuous manufacturing and reduce the amount of toxic chemicals used in the production of medicines. Denmark’s internationally acknowledged leadership in peptide processing and its expertise in green chemistry provides the company with an environment that will help it to further develop its groundbreaking µLOT® Technology. It will continue to work in close collaboration with both Copenhagen University and leading industry life science companies in both Denmark and Sweden.