Following the opening of its office in Boston earlier this year, UK based CDMO Quay Pharma has significantly extended its presence in the United States with the securing of a 55,000 sq ft facility for pharmaceutical development and clinical manufacturing.
The premises, in the Greater Boston area, will enable Quay to support the scaling up of products from Phase II to Phase III and the market introduction of products for oral and topical delivery, together with customer projects in small molecules as well as the oral and topical delivery of biologicals, including live biotherapeutics and other microbiome-based therapeutics. The new facility will be initially fitted out with analytical, formulation and pilot labs, and the first GMP manufacturing suites will be operating early Q3 2021. The site will create over 100 jobs within three years of being operational.
Since its foundation in 2002, Quay has built up a world-class reputation in formulation development and specialist clinical manufacturing, completing over 300 successful projects for a global client base from its UK site. The new US manufacturing operation will complement Quay’s existing European MHRA and FDA inspected facility in the UK to provide additional flexibility for future projects, with the ability to undertake clinical trial manufacturing from either site and allow rapid transfer between the two.
“This is an extremely exciting and at the same time a natural move for the company, as we have been working with a great many US clients for several years and have built up a strong and growing customer base in the country,” commented Maireadh Pedersen, Quay Pharma’s CEO. “The ability to support our customers from either location whilst understanding the regulatory differences between the EU and US will enable us to build in the groundwork for the relevant quality requirements at an early stage, allowing our customers to efficiently transition through the clinical phases as they expand their clinical trial sites around the world. The Greater Boston facility will be one of the first facilities established in the US for the development and manufacture of live biotherapeutic finished dosages and Quay will be the first company to support this type of manufacture for microbiome-based medicines in both Europe and the US.
“We are now able to respond even more speedily and also globally to support the development of new treatments, which will clearly be more critical than ever in the future, as underlined by the current fight against Covid-19.”
Local recruitment and work to equip the new facility is already underway, and senior Quay personnel from the UK will be overseeing the build of the infrastructure as well as starting to transition some customer projects to the new site during 2021.