Pharmaron - Taking Gene Therapy to the Next Level BF112

PHARMARON TAKING GENE THERAPY TO THE NEXT LEVEL

PHARMARON, A GLOBAL R&D SERVICE PROVIDER HEADQUARTERED IN BEIJING, IS LOOKING TO EXPAND ITS LIVERPOOL FACILITY IN THE UK TO MAKE IT A LARGER HUB FOR CELL AND GENE THERAPY MANUFACTURING.

TAKING GENE THERAPY TO THE NEXT LEVEL

PROJECT

MANAGED BY:

LIAM PYWELL

Pharmaron, one of the world’s leading life science service providers, has been investing heavily in the UK – today the company has 5 sites with over 900 employees in the UK, covering a broad spectrum of research, development and manufacturing service capabilities across multiple therapeutic modalities, including small molecules and gene therapy products.

Pharmaron’s Gene Therapy

(GT) CDMO (contract development and manufacturing organisation) operates out of state-of-the-art facilities in Liverpool. The site was previously Allergan’s global centre of excellence for biologic drug substance development and sold to Pharmaron by AbbVie in May 2021, following the latter’s acquisition of Allergan.

Pharmaron has since launched its GT CDMO business from the site and has continued to invest in worldclass innovation in viral vector and gene therapy analytical and

process technology, in order to support partners around the world. The company is now set to implement an ambitious plan for expansion of the Liverpool facility and is investing £151 million into the project, with support from a grant from the UK Government’s Life Sciences Innovation Manufacturing Fund (LSIMF).

The facility is set to be significantly expanded, providing a four-fold increase in gene therapy process development and analytical capacity, accommodating viral vector, DNA and RNA drug substances, plus drug product

Dr Derek Ellison, VP, Biologics Services Europe at Pharmaron.

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formulation. The expansion includes 3,500 m2 for future commercial-scale GMP capacity. The resulting facility will greatly enhance the scale and scope of Pharmaron’s services to vaccine, cell and gene therapy customers and will allow Pharmaron to continue expanding its scientific team at Liverpool.

PROVEN EXPERTISE

Dr Derek Ellison, VP, Biologics Services Europe at Pharmaron, explains that the facilities include advanced analytical platforms, high-throughput process development equipment and purposedesigned viral and plasmid GMP manufacturing suites.

Asked what makes Pharmaron different from other CDMOs he says: “There are two things that make us different. One is our pharma drug developer background; we really understand taking products to market, i.e., we look at any project from the beginning with the end in mind. We provide top expertise, not just on how

to make products, but how to get them approved, and how to develop them. That’s an important differentiator for us.”

“Superb analytics is another,” he adds. “On site, we have the best, leading analytical technologies. We work with manufacturers to develop new instrumentation, for example for gene therapies. Those two aspects are closely interlinked – the best technology goes with the expertise and the knowledge to really understand the product molecules that we are developing.”

The flexible cGMP biomanufacturing facility leverages its industry-leading expertise in a

broad range of biologic products and has also established a solid foundation and expertise in cell and gene therapy product development using a suspension system for manufacturing up to commercial scale. Working with our US lab services team, Pharmaron offers an end-to-end lab to manufacturing GT service.

PEOPLE AT THE CORE

Dr Ellison points out that the highly experienced and skilled talent pool within the organisation has been a fundamental aspect of its ongoing success and one of the key attractors for Pharmaron. He says: “We are very lucky

Pharmaron’s Viral CDMO Facility, Liverpool, UK.

GMP Manufacturing Suite – Large Scale GMP Chromatography Systems.

to have such a great team of people who have been loyal and stayed with us through a lot of changes, which has allowed us to retain this exceptional expertise.”

Human resources are one of the reasons why he is personally so excited about the expansion. “We are a really good place to work and our focus on people and their progression and development is significant. Pharmaron has developed excellent university links for graduates, is a founding member of the Advanced Therapies Apprenticeship Community and sponsors postgraduate degrees.”

“The planned extension will provide new career development opportunities for experienced staff also. It’s important to keep in mind that

if you want people to grow and develop, you need to give them the opportunities to allow that to happen.”

“This is something which is much easier to do within a dynamic, growing company that is prepared to invest. And Pharmaron is prepared to do just that. The excitement isn’t just about a bigger facility and expanded capacity but about the career development opportunities it will provide. And that’s positive for everybody. “

The company is preparing to double staff numbers, he acknowledges. Completing Stage II of the expansion, i.e., moving into GMP commercialscale manufacturing, would add approximately 170 people to the existing workforce of 180.

WE ARE ONLY SUCCESSFUL IF OUR CLIENTS ARE SUCCESSFUL, AND COMPLETING THEIR PROJECTS ON TIME AS REQUIRED IS AND WILL REMAIN OUR PRIORITY.”

Upstream Development Laboratory – Bioreactor Systems Support Design of Experiment (DoE) optimisation.

GENE THERAPY HUB

Following the acquisition, Pharmaron has added customers with 29 gene therapy and vaccine projects running through 2022, making use of the company’s enhanced capability. Through leveraging Pharmaron’s gene therapy plasmid development and in-house manufacturing capabilities, partners can simplify supply chains and take control over both the CMC development for their product and critical plasmid supply.

Pharmaron’s recent gene therapy CDMO partnership announcements include collaborations with Vaccitech to support its novel T-cell immunotherapeutics and vaccines development and manufacturing, and a strategic partnership for the development and clinical manufacture of gene therapy for the treatment of geographic atrophy with Complement Therapeutics Ltd.

In the future, Pharmaron will continue to invest in its industry-leading expertise in process R&D, cGMP manufacturing and advanced analytical capabilities to support its partners in the development and manufacture of gene therapy products.

The expansion, says Derek Ellison, will allow 12 products to be developed in parallel. “This is a very exciting time, but it is important to highlight that our existing facility will remain fully operational during, and after the expansion project. We are only successful if our clients are successful, and completing their projects on time as required is and will remain our priority.”

Analytical QC Laboratory - for release testing of cell banks, plasmids & viral vectors.