Lakes BioScience plans UK mAbs manufacturing facility

A FAST response UK biopharmaceutical manufacturing and process development factory which could help in the fight against Covid-19 and future pandemics is being planned by a partnership of pharma industry experts.

Lakes BioScience Ltd, formed 18 months ago from a collaboration of an industry-connected executive team promising a fast, agile, customer-focused approach, is accelerating plans due to global demand for monoclonal antibodies production.

Pat McIver, one of the founding directors of Lakes BioScience Ltd with more than 30 years of senior-level pharma industry experience, said: “Lakes BioScience will be a game changer, establishing the UK as a leading player in the global biopharmaceutical manufacturing market.

“Lakes BioScience is the company which is going to bring to life the notion of a uniquely agile and customer-focused, large-scale, biopharmaceuticals contract development and manufacturing operation in the UK.

“We will build on a rich regional and national capability and create high-value jobs in a fast-growing sector to deliver life-changing and life-saving treatments to patients globally.”

Mr McIver said now was the time for the UK to act and deliver the capability it urgently needs.

He said: “Supply chains are under huge pressure across the world to provide manufacturing capacity for monoclonal antibodies.

“We have submitted a planning application for the proposed new large-scale facility so we are in a position to respond to this demand.”

About 250 high value jobs will be created if Lakes BioScience’s Project Apex plan to build, commission and qualify a £350m biopharmaceuticals site in Ulverston, Cumbria, gets the go ahead.

Derek Willison-Parry, CEO of Lakes BioScience, has more than 30 years’ engineering, operational and strategic experience in the pharma industry working in Europe, China and the US.

Mr Willison-Parry said: “The time is most definitely now in terms of the global and UK need for this facility.

“Over the last three decades we have allowed other countries to support their biomanufacturing industry at the expense of ours.

“Now is the time to take the opportunity to correct that and reinvigorate the UK biomanufacturing industry.

“Lakes BioScience is that opportunity to reinstate the central importance of manufacturing, in this case biomanufacturing, in the UK.

“We have the team with world class skills and capability to respond to this global need in an innovative, customer-focused way, and we have the location.

“With Project Apex we will deliver a totally customer-focused contract development and manufacturing organisation.

“That will mean that in the future, when there is a future public health emergency such as Covid-19 is impacting us now – and it will be a case of ‘when’ not ‘if’ – we as a country will be stronger in our response.

“We will be able to more quickly develop and manufacture the drugs in order to be able to counter that public health emergency.

“This project is building a facility that would be able to manufacture requirements for Covid-19 therapies in a record time.

“If we are successful we will be contributing to controlling this coronavirus and Covid-19 to the extent that we can start to return to normal.

“Now is the time for those who want this to happen in the UK to make sure that together we grasp this opportunity.”

Lakes BioScience’s vision is that its site will become a major centre for expertise, research and development, manufacturing, and learning.

Mr Willison-Parry said: “What we will create with Project Apex will be a huge driver for growth for industries and universities specialising in the manufacture of biopharmaceuticals.

“It will meet an urgent need for manufacturing capability and capacity in the UK, and also be a catalyst for a grand vision for creating a legacy of skills and expertise in biopharmaceuticals in the UK through PHD, graduates, apprentices and technicians.

“There’s a strong desire for the manufacturing facility to be the catalyst for a major site of high-tech life science manufacturing innovation through mentoring, teaching and learning which will evolve as the science evolves to create a lasting legacy for the UK.

“Other countries, such as the USA manage to achieve this.

“The time is now for the UK and Lakes Bioscience to make this happen with a rapid, agile programme which will enable it to play a key role in a Northern Powerhouse hub of biopharmaceutical capability and capacity.”

Lakes BioScience projects director Adrian Wallis, who has more than 40 years of industry senior management and executive experience working for ICI and Novartis, says speed is of the essence when it comes to delivering on the opportunity.

Mr Wallis said: “Our ability to deliver a production manufacturing facility from ground to first product in a fast time is something which is really important right now in terms of a response to the Covid-19 pandemic.

“Lakes BioScience can provide the pace and speed of response which is required and we have reinvigorated many of our stakeholders’ views about manufacturing being based in the UK.

“Our proposition is to be able to deliver antibodies to the patients that desperately need them and save lives.

“As well as our innovative ability to build the plant to a short timescale and to run the facility, Lakes BioScience is also perfectly positioned to respond to antibody therapy requirements as they change.”

Mr McIver said that longer term vision was also really important in terms of building a sustainable business to deliver growth for the sector.

He said: “Biopharmaceuticals are among the most important medicines that are reaching patients today and they will be in the longer term.

“This is about creating something which can be the seed for growth of the biopharmaceutical sector in the UK.

“It’s also about establishing the UK as a serious participant in the global biopharmaceutical market.

“The research and development, the ideas, the innovations that are happening in the UK are serving a global population.

“Why don’t we do biopharmaceutical manufacturing in the UK? We have all of the know-how, all of the capability, we have brilliant scientists, brilliant engineers, brilliant people, so why aren’t we doing it? At Lakes BioScience we can’t find an answer to that question. So we are going to make this happen.”

Mr McIver points to the expertise of the Lakes BioScience team who have a track record of working fast to ensure rapid and agile responses in delivering customer-focused, innovative and effective solutions.

He said: “A strength of Lakes BioScience’s is the strength of partnership we’ve brought together. We’ve got people, companies and organisations with a tremendous amount of experience, who are leaders in the industry.

“As a team we can bring together the very best people to establish the very best biopharmaceutical manufacturing in the UK.

“Our ambition is to be the best in the world and we have the people who can make that happen.”

Simon Chalk, a strategic advisor to Lakes BioScience, is owner and director at BioPhorum Operations Group and has spent 20 years in the industry specifically working on monoclonal antibody projects across the world.

Mr Chalk said: “I am inspired by this project. Lakes BioScience is a UK-based organisation which will deliver agile, world-class, biopharmaceutical manufacturing capacity to the industry.

“It will fill a gaping hole in UK-based life science capabilities and will catalyse commercial scale biomanufacturing nationally, while also creating jobs and trade.”

Ian Allan is the chief technical officer for Lakes BioScience and managing director of the Digital Technologies Group with more than 35 years’ experience of facility technology design and programme delivery of systems and applications.

Mr Allan said: “These are really exciting times, creating a Digital Factory Solution for a world problem, and delivering a project executed in the UK with first-class expertise.”

Gino Martini, Visiting Professor of Pharmaceutical Innovation at King’s College, London, is a director of the hugely experienced Lakes BioScience team.

Prof Martini said: “Project Apex is an amazing opportunity for change, the opportunity to work with like-minded individuals, people who share my passion, my commitment to make the UK great again when it comes to medicines manufacturing.

“I think UK life sciences, UK research, and our universities are the best in the world and so is discovery and development in manufacturing. So I’ve been disappointed, like many people, to see a lot of our key inventions be farmed out abroad. This is an opportunity to redress that balance, to make us independent, self-reliant and to discover, develop and manufacture in the UK.

“Covid-19 is obviously a major catalyst but the reality was that we were looking at this mission over 18 months ago.

“In fact, if you look at what the French have been doing, what the Germans have been doing, when it comes to antibiotics, they’ve started to re-shore antibiotics manufacture to their countries because they were really concerned about over-reliance on external, foreign suppliers of their medicines. What Covid-19 has done is accelerated those concerns.”

Lakes BioScience has submitted its plans for a manufacturing site in Ulverston to South Lakeland District Council. A decision on planning permission is likely to be made this month.

Residents got their first chance to see plans for the site when Lakes BioScience held a recent exhibition in the town.

Lakes BioScience hopes to start work on the site later this year with manufacture of advanced monoclonal antibodies due to start in 2022.