General – Seda https://www.sedapds.com Wed, 19 Nov 2025 15:13:51 +0000 en-GB hourly 1 UK nuclear revolution powers next–generation precision cancer therapies https://www.sedapds.com/news/uk-nuclear-revolution-powers-next-generation-precision-cancer-therapies/?utm_source=rss&utm_medium=rss&utm_campaign=uk-nuclear-revolution-powers-next-generation-precision-cancer-therapies Wed, 19 Nov 2025 15:13:51 +0000 https://www.sedapds.com/news/ The UK is set to give a unique second life to used nuclear materials. A £9.9m investment from the Innovate UK Sustainable Medicines Manufacturing Innovation Programme (SMMIP), backed by a further £8.9m from industry, will support a major project to develop cutting-edge new treatments for cancer. Led by United Kingdom National Nuclear Laboratory (UKNNL) and Medicines Discovery...

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The UK is set to give a unique second life to used nuclear materials. A £9.9m investment from the Innovate UK Sustainable Medicines Manufacturing Innovation Programme (SMMIP), backed by a further £8.9m from industry, will support a major project to develop cutting-edge new treatments for cancer.

Led by United Kingdom National Nuclear Laboratory (UKNNL) and Medicines Discovery Catapult (MDC), the project will use a radionuclide called lead-212 to create treatments called Targeted Alpha Therapies.

These treatments are a type of precision medicine, known as radiopharmaceuticals. Whilst radionuclides are already used worldwide for medical scans to diagnose cancer and other conditions, Targeted Alpha Therapy is an exciting new application. Lead-212 could offer hope to patients with cancers that are currently hard to treat by targeting and destroying cancer cells with minimal damage to healthy tissue and reduced side effects.

UKNNL has developed a way to harvest a sustainable supply of lead-212 from recycled nuclear fuel that has already been used to power homes across the country.

A tiny amount of lead-212’s parent material – equivalent to a single drop of water in an Olympic-sized swimming pool – is extracted through a series of chemical reactions. An even tinier amount of lead-212 is taken from this sample, which, when developed under the right conditions by scientists at MDC, could treat thousands of patients.

The UK has large reserves of lead-212, meaning that this approach could be scaled up to power new cancer treatments for patients in the UK and worldwide.

The funding from the SMMIP will develop the foundations needed to support clinical trials and bring these treatments to patients. This will unlock the UK’s full potential as a global leader in this ground-breaking area of cancer care.

Science and Technology Secretary Liz Kendall said:

“Almost 3.5 million people in the UK are living with cancer – but scientific breakthroughs are giving hope to more of them and their families.

“It’s incredible to think that we could turn used nuclear fuel into cutting edge cancer treatments – but that is exactly what British scientific brilliance is making possible. Remarkable work like this, which could give cancer patients more priceless time with their loved ones, shows precisely why this Government is giving record funding to research and development.”

Julianne Antrobus, Chief Executive Officer at UKNNL, said:

“Through access to the UK’s sovereign supply of lead-212, we have a truly unique opportunity to transform our nuclear expertise into life-saving cancer treatments. Developed from recycled fuel that has already served the nation by powering homes, lead-212 can now serve us again by offering new hope to cancer patients.

“UKNNL is proud to co-lead this pioneering programme alongside Medicines Discovery Catapult. By developing the infrastructure and processes to unlock the UK’s lead-212 supply, we’re not only advancing precision nuclear medicine but also reinforcing the UK’s position as a world leader in both nuclear science and healthcare innovation. This investment will help us deliver treatments that could transform outcomes for patients with previously untreatable cancers, both here in the UK and globally.”

Professor Chris Molloy, CEO of Medicines Discovery Catapult, said:

“Lead-212 is an untapped national asset with extraordinary medical potential. By developing therapies from this uniquely sustainable source, with no additional waste, our consortium has the ambition to improve cancer care for patients and to position Britain once again at the forefront of medicinal radiochemistry. But ambition alone isn’t enough. We need the infrastructure to produce, trial, and scale this evergreen approach. The support from Innovate UK’s Sustainable Medicines Manufacturing Innovation Programme gives us the resources to realise our ambition, and is a clear signal that the UK is ready to innovate for patients here and around the world.”

Dr Mark Talford – Deputy Director, Medicines Manufacturing at Innovate UK, said:

“This project demonstrates the power of UK innovation to tackle some of the most pressing challenges in healthcare. By transforming legacy nuclear materials into life-saving cancer treatments, we are not only advancing precision medicine but also demonstrating how sustainability and science can work hand in hand. Through the Sustainable Medicines Manufacturing Innovation Programme, Innovate UK is proud to support this pioneering collaboration that will accelerate access to cutting-edge therapies for patients and strengthen the UK’s position as a global leader in both medicines and nuclear innovation.”

UKNNL is the Government’s lead civil national laboratory for nuclear fission whose mission is twofold: to enable and deliver nuclear outcomes for government, and to support growth of the UK nuclear sector. A national asset operating ground-breaking technology through world-class expertise, UKNNL is enabling the supply of new sources of medical isotopes for the UK. It collaborates with researchers to investigate new treatments and diagnoses, including cancer, Alzheimer’s and complex heart conditions. The handling of nuclear material and extraction of isotopes are key capabilities and skills that UKNNL provides for the nation.

MDC is a national Life Sciences service dedicated to turning drug discovery into impactful and commercial breakthroughs. It has a high-tech preclinical lab with world-class radiochemistry capabilities and advanced imaging technologies, unique within the UK and a major asset in the development and deployment of novel radiopharmaceuticals.

The project brings together world-class expertise to develop a complete ecosystem. Its five other consortium members are Cyclife Aquila Nuclear, PentaBind, Iksuda Therapeutics, Seda, and entX. Their combined capabilities will build the necessary infrastructure, develop and test the treatments, and deliver a strategy to bring these game-changing medicines to market.

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Seda co-founders and CEO named in the UK’s Top 50 Most Ambitious Business Leaders for 2025 https://www.sedapds.com/news/seda-co-founders-and-ceo-named-in-the-uks-top-50-most-ambitious-business-leaders-for-2025/?utm_source=rss&utm_medium=rss&utm_campaign=seda-co-founders-and-ceo-named-in-the-uks-top-50-most-ambitious-business-leaders-for-2025 Thu, 09 Oct 2025 12:59:59 +0000 https://www.sedapds.com/news/ Dr Paul Dickinson, Chief Scientist & Co-founder, Dr Marcel de Matas MBE, Chief Business Officer & Co-founder and Dr Paul Stott, CEO of Seda have been recognised in The LDC Top 50 Most Ambitious Business Leaders for 2025.  The Top 50 was created by LDC, the private equity investor that is part of Lloyds Banking...

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Dr Paul Dickinson, Chief Scientist & Co-founder, Dr Marcel de Matas MBE, Chief Business Officer & Co-founder and Dr Paul Stott, CEO of Seda have been recognised in The LDC Top 50 Most Ambitious Business Leaders for 2025. 

The Top 50 was created by LDC, the private equity investor that is part of Lloyds Banking Group, in partnership with The Times. Now in its eighth year, the programme continues to celebrate the drive and ambition of Britain’s best and brightest entrepreneurs. 

This year the programme received almost 700 nominations, showcasing the exceptional individuals that are building successful, growing medium-sized businesses right across the UK.  

The business leaders featured in The LDC Top 50 for 2025 are making a powerful impact by creating jobs, making a difference in the communities they serve, championing sustainability and expanding internationally. They are also demonstrating resilience as they drive growth and develop new ideas to innovate and diversify. 

They operate from 67 towns and cities across the UK and span every sector of the economy, whilst collectively they employ almost 10,000 people and generate combined revenues of £1.2bn. 

Seda Pharmaceutical Development Services provides Integrated Pharmaceutical Development and Clinical Pharmacology services and Consultancy to the Pharma and Biotechnology Industries. Our GMP manufacturing division, Seda Clinical Manufacturing Services, provides comprehensive services for the establishment, testing, manufacturing, and distribution of oral dosage forms for clinical trials. 

Paul-Dickinson-Marcel-de-Matas-Paul-Stott-UK’s-Top-50-Most-Ambitious-Business-Leaders-for-2025

Paul Dickinson, Chief Scientist & Co-founder of Seda said: ‘Thank you to Gillian Sharman for championing NW companies and Seda Pharmaceutical Development & Clinical Manufacturing Services in particular.’

Marcel de Matas, Chief Business Officer & Co-founder of Seda said: ‘Great to be recognised in the Top 50 ambitious business leaders in the UK. Proud to be part of such a fantastic leadership team. Hopefully much more to come over the next few years.’ 

Paul Stott, CEO of Seda said: It’s wonderful to be recognised alongside a cohort of fantastic UK leaders. It feels like we are still at the start of our journey with Seda, with lots more exciting things to come.’ 

John Garner, Managing Partner at LDC, added: “In the eight years since we launched The LDC Top 50 we’ve had the honour of meeting some exceptional business leaders. This year’s cohort has shown drive and ambition in their growth journeys, proven remarkable resilience, and together they are making a real difference to their employees, the communities they work in and society at large. I’d like to congratulate them on everything they’ve achieved so far. Their success stories are only just beginning, and we’re excited to see where their journey takes them next.” 

Read more about The LDC Top 50 Most Ambitious Business Leaders for 2025 here: Dr Paul Dickinson Dr Marcel de Matas MBE and Dr Paul Stott – LDC

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Celebrating 10 years of Seda https://www.sedapds.com/news/celebrating-10-years-of-seda/?utm_source=rss&utm_medium=rss&utm_campaign=celebrating-10-years-of-seda Wed, 16 Jul 2025 13:22:53 +0000 https://www.sedapds.com/news/ What began as a vision by two scientists 10 years ago — to transform drug development by integrating pharmaceutical development and clinical pharmacology — has evolved into an exceptional and unique concept in pharmaceutical contract service provision.   In 2015, Seda was founded at Alderley Park, UK, by Paul Dickinson and Marcel de Matas as a...

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What began as a vision by two scientists 10 years ago — to transform drug development by integrating pharmaceutical development and clinical pharmacology — has evolved into an exceptional and unique concept in pharmaceutical contract service provision.  

In 2015, Seda was founded at Alderley Park, UK, by Paul Dickinson and Marcel de Matas as a consultancy-led venture. Operating in lean start-up mode, they set out to test whether integrating clinical pharmacology and pharmaceutical development could deliver real value to biotech and other clients by guiding the development of new medicinal products for clinical evaluation. 

Marcel-de-Matas

‘From Paul Dickinson and me sitting in the BioHub at Alderley Park with nothing but laptops, 10 years ago, to a rapidly growing contract research, development and manufacturing organisation serving customers in some of the world’s most active biotech hotspots. I’m not sure we could have imagined such a rapid evolution at that time. Thanks to all our staff, associates, collaborators, investors and business partners, for making the last decade such a success. Here’s to the next 10 years.’ – Marcel de Matas, Chief Business Officer & Co-founder

Building on the proven value of its integrated approach, in 2017 Seda expanded to provide laboratory services for the design and testing of investigation medicinal products and modelling of product performance in animals and humans to meet growing client demand. 

In 2019, Paul Stott, formerly Vice President of Global Product Development at AstraZeneca, joined Seda as CEO to lead the scale-up of its unique integrated offering – bringing deep industry experience to guide the next phase of growth. 

‘It has been an absolute privilege and the highlight of my career to be a part of the Seda journey. I am immensely proud of the team that have taken us to this point and excited about what is still to come.’ – Paul Stott, CEO. 

Expansion continued in 2020, with continued growth within the team, clients and projects, Seda moved to a larger laboratory and office at Alderley Park. 

In 2021, Oakfield HQ was acquired. To support the continued growth and long-term vision, Seda acquired a larger, purpose-built development facility at Cheadle Royal Business Park. The new Oakfield HQ provided expanded space for collaboration, innovation and project delivery. 

As part of a strategic investment for service expansion, in 2023, Seda acquired the 50,000sq ft Lakehouse building on the same campus. The investment created the space and infrastructure needed to support future capabilities and broaden the integrated development offering to include GMP manufacture and supply of investigational medicinal products into clinical trials. 

In 2024, Seda announced our expansion into GMP services, marking a major step in extending our capabilities to include clinical manufacturing. This expansion allows the company to support clients further along the development pathway, offering end-to-end continuity from early-phase strategy through to clinical supply. 

Over the years Seda has received numerous awards celebrating its innovation and impact. In May 2024, this recognition reached new heights as the company is named a winner of the King’s Award for Enterprise in the Overseas Trade category in recognition of global reach and sustained growth. 

In February 2025 Seda received MHRA approval for our GMP facility, a major regulatory milestone that enables us to manufacture clinical IMPs under licence. We proudly marked a major milestone with the launch of Seda CMS — a new investigational medicinal product manufacturing capability that completes our evolution into a fully integrated, end-to-end service delivering scientific excellence at every stage of the drug development journey. 

Paul-Dickinson

‘10 years, seems like 10 minutes! 10 years ago, only in our wildest dreams, might we have hoped to be working on such exciting and diverse projects that are at the cutting edge of medical innovation. So, listen to your wildest dreams!’ – Paul Dickinson, Chief Scientist & Co-founder 

 We would like to say a huge thank you to our incredible team, loyal clients, and trusted partners. You’ve been part of every step of our 10-year journey. Here’s to the next chapter – together. 

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Seda Wins Medilink Award for Outstanding Achievement https://www.sedapds.com/news/seda-wins-prestigious-medilink-award-for-outstanding-achievement/?utm_source=rss&utm_medium=rss&utm_campaign=seda-wins-prestigious-medilink-award-for-outstanding-achievement Mon, 16 Jun 2025 14:55:11 +0000 https://www.sedapds.com/news/ Seda are thrilled to announce that we have been awarded the Medilink Award for Outstanding Achievement, in recognition of the launch of Seda Clinical Manufacturing Services division with state-of-the-art GMP facility.  This inception integrates model-informed formulation design, clinical pharmacology services and GMP manufacturing, creating a seamless service for optimised dosage forms. This innovative integration speeds up...

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Seda are thrilled to announce that we have been awarded the Medilink Award for Outstanding Achievement, in recognition of the launch of Seda Clinical Manufacturing Services division with state-of-the-art GMP facility. 

This inception integrates model-informed formulation design, clinical pharmacology services and GMP manufacturing, creating a seamless service for optimised dosage forms. This innovative integration speeds up the delivery of investigational medicines, improving efficiency and reducing development timelines. Additionally, Seda designed bespoke quality systems tailored to early-phase clinical manufacturing, integrating regulatory compliance with operational flexibility for rapid project execution.  The launch of Seda Clinical Manufacturing Services has significantly enhanced our end-to-end pharmaceutical development capabilities, accelerating drug development timelines, especially critical in oncology.  

Seda’s bespoke quality system ensures rapid project execution while ensuring full compliance with GMP standards. This transformative step sets Seda apart by providing a comprehensive solution for global biotechs, driving innovation and boosting the UK’s global standing in life sciences. Addressing the need for agile, small-scale, early-phase GMP manufacturing and creating 100 high-skilled jobs, Seda reinforces Manchester’s reputation as a thriving biotech hub, contributing to the region’s economic growth and scientific advancements. 

Seda’s partnership with Santander NW involved meticulous planning and development. The £8.5 million investment, supported by a £5.5 million flexibly structured loan, was strategically aligned with construction and commissioning milestones. Santander’s phased disbursement plan ensured funding was available when needed, while full interest accrued only on drawn down funds. This innovative financing strategy mitigated revenue downtime challenges pre-MHRA inspection. Opting for bank financing over VC or PE funding allowed Seda to retain operational autonomy. 

This award highlights Seda’s unwavering commitment to uphold high-quality standards and innovative solutions through cutting-edge technology, sustainable practices, and a relentless focus on quality and impact. 

The Medilink Awards are known for spotlighting organisations that demonstrate exceptional performance, and this accolade is a testament to the dedication, creativity, and hard work of the entire Seda team. 

Receiving the Outstanding Achievement Award is not only a proud moment for us but also a powerful motivator to continue pushing boundaries and delivering meaningful change in the industry. We would like to thank Medilink and all our partners, clients, colleagues and Santander who have supported us on this journey.  

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MHRA license approved for GMP Manufacturing https://www.sedapds.com/news/mhra-license-approved-for-gmp-manufacturing/?utm_source=rss&utm_medium=rss&utm_campaign=mhra-license-approved-for-gmp-manufacturing Mon, 16 Jun 2025 14:20:19 +0000 https://www.sedapds.com/news/ Seda are delighted to announce The Medicines and Healthcare products Regulatory Agency (MHRA) approval of our Good Manufacturing Practice (GMP) Manufacturer’s Authorisation.  The MHRA has officially granted Seda a GMP license, marking a significant milestone in Seda’s company growth since its inception.  The GMP license has been awarded after rigorous inspections and compliance checks, ensuring...

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Seda are delighted to announce The Medicines and Healthcare products Regulatory Agency (MHRA) approval of our Good Manufacturing Practice (GMP) Manufacturer’s Authorisation. 

The MHRA has officially granted Seda a GMP license, marking a significant milestone in Seda’s company growth since its inception. 

The GMP license has been awarded after rigorous inspections and compliance checks, ensuring that we meet the highest standards of quality and safety in the production of medicinal products. This approval not only enhances our credibility but also opens new avenues to accelerate our clients’ transition into and through the clinical phases of development by providing GMP product and associated testing of the very highest quality. 

The GMP license will allow us to combine the expertise of our development and manufacturing divisions, positioning ourselves as a trusted partner, supporting our clients throughout their entire development journey. Offering a seamless transition from development into clinic. 

The MHRA’s GMP certification is a testament to the Seda team and our dedication to quality and regulatory compliance. It reflects our ongoing efforts to adhere to stringent manufacturing practices and ensure the consistent production of high-quality medicinal products. 

CEO Paul Stott commented ‘This marks the transition of Seda into a full service CDMO. I am incredibly proud of what the team has achieved and excited to see the evolution of our service offering. Thanks to everyone who has supported us along the way.’ 

To find out further information about our capabilities following our GMP authorisation take a look at our Clinical Manufacturing Services website or contact us to find out more about how we can support your programme. 

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Seda Wins Bionow Investment Deal of the Year 2024 https://www.sedapds.com/news/seda-wins-bionow-investment-deal-of-the-year-2024/?utm_source=rss&utm_medium=rss&utm_campaign=seda-wins-bionow-investment-deal-of-the-year-2024 Wed, 12 Mar 2025 15:18:51 +0000 https://www.sedapds.com/news/ Seda Pharma Development Services has proudly received the prestigious Bionow Investment Deal of the Year 2024 award. This honour recognises the transformative impact of their £5.5 million Capital Growth funding from Santander NW Ltd, which has been crucial in developing their state-of-the-art GMP manufacturing facility.   This innovative funding deal combined traditional financing with tailored...

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Seda Pharma Development Services has proudly received the prestigious Bionow Investment Deal of the Year 2024 award. This honour recognises the transformative impact of their £5.5 million Capital Growth funding from Santander NW Ltd, which has been crucial in developing their state-of-the-art GMP manufacturing facility.

 

This innovative funding deal combined traditional financing with tailored structures to support Seda’s growth. Santander’s phased disbursement plan ensured funding was aligned with construction and commissioning milestones, with interest accruing only on drawn-down funds. These flexible terms were essential in mitigating challenges, such as revenue downtime before MHRA inspection. Over a trusted nine-year partnership, open dialogue and a shared commitment to UK life sciences have solidified this collaboration. Choosing bank financing over VC or PE funding allowed Seda to maintain operational autonomy, ensuring a steadfast focus on client service excellence.

The launch of Seda Clinical Manufacturing Services strengthens the UK’s position as a global leader in life sciences, generating over 50% of its revenue from international markets and repatriating contracts typically outsourced to lower-value regions like China. Beyond exports, the facility stimulates local economic growth, creating up to 100 high-skilled jobs and fostering collaboration within Manchester’s thriving biotech ecosystem. By showcasing the UK’s capabilities in pharmaceutical innovation, Seda is contributing to a stronger, more competitive global presence for the nation’s life sciences sector.

This partnership between Seda and Santander NW exemplifies the impact of strategic, flexible financing and visionary leadership. Together, they are setting new benchmarks for fostering innovation, driving economic growth, and advancing life-saving therapies on a global scale.

Debbie Worthington, Relationship Director Commercial Clients, Corporate and Commercial of Santander said of the award;

“Congratulations to Seda’s well deserved win at the Bionow awards for the Investment Deal of the year. We are delighted to see a company that has banked with us since inception grow so rapidly and have such an exciting future. Seda are making a significant and positive contribution to medical science globally. As their banking provider, we feel proud and privileged to be able to support this next phase of their growth.”

Seda CEO, Paul Stott, remarked;

“We are deeply honoured to receive the Bionow Investment Deal of the Year Award. Debbie and the team at Santander have been exceptional partners throughout our journey, providing invaluable patience, guidance, and flexibility to support our growth and expansion.”

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Andy Burnham Opens Seda’s State-of-the-Art GMP Facility https://www.sedapds.com/news/andy-burnham-opens-sedas-state-of-the-art-gmp-facility/?utm_source=rss&utm_medium=rss&utm_campaign=andy-burnham-opens-sedas-state-of-the-art-gmp-facility Thu, 28 Nov 2024 14:26:15 +0000 https://www.sedapds.com/news/ Andy Burnham, Mayor of Greater Manchester, Inaugurates Seda’s New State-of-the-Art GMP Facility, Projected to Generate 100 Jobs and Boost UK Life Sciences Sector Cheadle, Greater Manchester, UK, 22nd November — In a significant milestone for the North’s life sciences sector, Andy Burnham, Mayor of Greater Manchester, officially opened Seda Group’s new state-of-the-art drug product GMP...

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Andy Burnham, Mayor of Greater Manchester, Inaugurates Seda’s New State-of-the-Art GMP Facility, Projected to Generate 100 Jobs and Boost UK Life Sciences Sector

Cheadle, Greater Manchester, UK, 22nd November — In a significant milestone for the North’s life sciences sector, Andy Burnham, Mayor of Greater Manchester, officially opened Seda Group’s new state-of-the-art drug product GMP (Good Manufacturing Practice) facility. The event was marked by a tour of the cutting-edge site, where Andy was accompanied by Labour MP for Waddon, Councillor Rowenna Davis. This new facility promises to enhance Greater Manchester’s reputation as a hub for life sciences innovation and is expected to create up to 100 high-skilled jobs over the next five years, with more than half of its projected revenue coming from international clients.

Mayor of Greater Manchester, Andy Burnham, with Dr. Paul Dickinson (Seda Co-founder and CSO), Dr. Marcel de Matas (Seda Co-founder and CTO), and Dr. Paul Stott (CEO)

The newly established division, Seda Clinical Manufacturing Services (CMS), complements Seda’s existing Pharmaceutical Development Services (PDS) arm, expanding into GMP manufacturing, testing, and supply. The facility enables Seda to supply investigational medicinal products for testing in clinical studies by their global biotech client partners.

Andy Burnham, Mayor of Greater Manchester, with Paul Stott, Seda CEO

“We are thrilled to expand our capabilities with the launch of Seda CMS, enhancing our support for both domestic and international clients,” said Dr. Paul Stott, CEO. “This facility not only generates jobs and revenue but also reinforces the North of England’s role as an innovation hotspot.”

Located adjacent to Seda Pharmaceutical Development Services (PDS), this expansion builds on nearly a decade of success. Founded in 2015, to address a gap in the market for pharmaceutical development integrated with clinical pharmacology, Seda has consistently innovated to meet unmet client needs and growing demand. In 2019, it relocated to state-of-the-art labs and offices on Cheadle Royal Business Park and saw substantial growth despite the recent economic climate. This £8 million investment, partially funded by Santander NW, positions Seda to supply drugs for Phase 1 and 2 clinical trials, with its robust order book for GMP manufacturing pending MHRA approval and licensing.

Andy Burnham (third from right) with members of the Seda Leadership Team (L-R Linette Ruston, Vijay Masaun, Effi Baetzner, Mike Hingley, Shanoo Budhdeo and Darren Gill)

The opening follows Seda’s recognition with the prestigious 2024 King’s Award for Enterprise in International Trade. Drawing ~60% of its revenue from international markets, Seda exemplifies global trade excellence while driving local economic growth.

Mayor Andy Burnham’s presence underscored Manchester’s commitment to fostering innovation. “This facility serves to support the local and UK Life Sciences infrastucture” he noted during the tour.

Mayor and councillor in GMP facility
Andy Burnham and Councillor Rowenna Davis during a tour of Seda’s state-of-the-art GMP facility

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Paul Dickinson presents at the PBBM Conference 2024 https://www.sedapds.com/news/paul-dickinson-presents-at-the-pbbm-conference-2024/?utm_source=rss&utm_medium=rss&utm_campaign=paul-dickinson-presents-at-the-pbbm-conference-2024 Wed, 27 Nov 2024 11:41:00 +0000 https://www.sedapds.com/news/ Seda’s Paul Dickinson took the stage at the PBBM (Physiologically Based Pharmacokinetics Modelling) Conference 2024, hosted by the MHRA and APS. The event was a fantastic opportunity for regulatory agencies, innovator and generic drug companies, consultants, academia, commercial software providers, and others in the field of oral drug product modelling and simulation to come together...

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Seda’s Paul Dickinson took the stage at the PBBM (Physiologically Based Pharmacokinetics Modelling) Conference 2024, hosted by the MHRA and APS. The event was a fantastic opportunity for regulatory agencies, innovator and generic drug companies, consultants, academia, commercial software providers, and others in the field of oral drug product modelling and simulation to come together and explore the latest advancements in PBBM while influencing the future pathway for regulatory use.

About Paul’s Talk:
Paul’s presentation was titled: Clinically Relevant Dissolution Specifications: Implications for Use in the Post-Marketing Setting & Tension with f2 Similarity Testing. We are proud to see Paul, one of the originators of the “safe space” concept, contributing to this vital conversation. His influential paper on the Clinical Relevance of Dissolution Testing in Quality by Design has set a benchmark in our field.

Access the slides from Paul’s presentation can be found here.

For me the big ticket CMC items to get ticked off as soon as possible for any NDA/MAA submission are:
1. Dissolution method and specification
2. Registered Staring Material
because if these are not accepted the whole CMC package is at risk and the ‘right’ answer is open to interpretation. PPBM can support the Sponsors justification of Item 1 and so maybe of critical value in regulatory discussions and so it is good for drug developers to have awareness of the strengths and limitations of PPBM is supporting approval and post-approval changes. As an aside in any submission demonstration of good control and understanding of API solid-state form /polymorph is also an important factor sometimes overlooked in dossiers. – Paul Dickinson, Chief Scientist

This was an inspiring event that will shape the future of biopharmaceutics!

Read more about Seda’s pk modelling services or contact us to speak to one of our expert team.

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Seda Launches Clinical Manufacturing Services (CMS) https://www.sedapds.com/news/seda-launches-clinical-manufacturing-services-cms/?utm_source=rss&utm_medium=rss&utm_campaign=seda-launches-clinical-manufacturing-services-cms Wed, 23 Oct 2024 13:34:53 +0000 https://www.sedapds.com/news/ We are thrilled to announce that Seda has reached an exciting new chapter with the launch of our Clinical Manufacturing Services (Seda CMS)!   Our manufacturing facility is now fully completed, commissioned, and ready to take on client projects.  As a complementary division of the Seda group, Seda CMS was created to provide a seamless...

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We are thrilled to announce that Seda has reached an exciting new chapter with the launch of our Clinical Manufacturing Services (Seda CMS)!  

Our manufacturing facility is now fully completed, commissioned, and ready to take on client projects. 

As a complementary division of the Seda group, Seda CMS was created to provide a seamless transition from the development of investigational medicinal products to their GMP manufacturing, testing, and supply.  

This new division offers state-of-the-art facilities co-located on the same campus as Seda Pharmaceutical Development Services (PDS), while maintaining a dedicated team of experts and independent quality systems. 

Seda CMS upholds the same exceptional quality standards you’ve come to expect from Seda PDS, ensuring precision, compliance, and excellence in all of our GMP clinical manufacturing services. 

Maximise your value from asset to approval with Seda CMS 

‘I am extremely proud of what the team has achieved here. It has been a momentous effort to reach this milestone and sets us up to provide an end-to-end service to our client partners.’ – Paul Stott, CEO

‘Another fantastic string to the Seda bow’ – Marcel de Matas, Co-Founder and Chief Business Officer

 Contact us at enquiries@sedacms.com to discuss your GMP clinical manufacturing requirements. 

Witness our extraordinary journey from empty space to state-of-the-art facility; 


 

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Seda attend a Civic Reception to celebrate King’s Award win https://www.sedapds.com/news/seda-attend-a-civic-reception-with-the-mayor-of-stockport-in-recognition-of-receiving-kings-award-for-enterprise-2024/?utm_source=rss&utm_medium=rss&utm_campaign=seda-attend-a-civic-reception-with-the-mayor-of-stockport-in-recognition-of-receiving-kings-award-for-enterprise-2024 Wed, 17 Jul 2024 13:48:41 +0000 https://www.sedapds.com/news/ On Monday 15th July, we had the privilege of attending a civic reception, hosted by the Mayor of Stockport, Councillor Suzanne Wyatt, inside the impressive surroundings of Stockport Town Hall to celebrate the King’s Award win. We were also joined by Leader of Stockport Borough Council Councillor Mark Hunter, Immediate Past Mayor of Stockport Councillor...

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On Monday 15th July, we had the privilege of attending a civic reception, hosted by the Mayor of Stockport, Councillor Suzanne Wyatt, inside the impressive surroundings of Stockport Town Hall to celebrate the King’s Award win.

We were also joined by Leader of Stockport Borough Council Councillor Mark Hunter, Immediate Past Mayor of Stockport Councillor Graham Greenhalgh, Deputy Lieutenants Mr Paul Brearley JP, Mr Gerry Yeung OBE and Rev Charles Kwaku-Odoi, who all joined us to celebrate our achievement of being Stockport’s only recipient of the King’s Award for Enterprise 2024.

During the reception, we discussed Seda’s exceptional growth, future growth potential through our investment and expansion into GMP manufacturing, our rapidly expanding global Client portfolio and the positive impact this is having on the local economy and our ability to create new, high-skilled jobs in the region.

A special thank you to Madam Mayor Suzanne for hosting this wonderful event and for the opportunity to connect with the other Council leaders and Deputy Lieutenants.

We welcome the opportunity to continue this collaboration with our local community leaders to drive positive change into the Stockport eco-system.

About King’s Awards for Enterprise
The King’s Awards for Enterprise are the most prestigious business awards in the UK. The awards were first established in 1965 and since then over 7000 companies have achieved a King’s Award. 2024 marks the second year of The King’s Awards for Enterprise, reflecting His Majesty The King’s desire to continue the legacy of HM Queen Elizabeth II’s by recognising outstanding UK businesses.

The awards celebrate the success of exciting and innovative businesses which are leading the way with pioneering products or services, delivering impressive social mobility programmes, or showing their commitment to excellent sustainable development practices.

This year 252 businesses have been recognised for their contribution to International Trade, Innovation, Sustainable Development and Promoting Opportunity (through Social Mobility). A total of 257 Awards are made with five companies being recognised with two Awards.

The King’s Awards for Enterprise 2024 include:
• 161 Awards for International Trade
• 59 Awards for Innovation
• 29 Awards for Sustainable Development
• 8 Awards for Promoting Opportunity (through social mobility)

Congratulations to our fellow Kings Award winners. Click here for the full list.

 

The post Seda attend a Civic Reception to celebrate King’s Award win appeared first on Seda.

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