Indian conglomerate Piramal Group’s Pharma Solutions business opened its expanded antibody-drug conjugate (ADC) manufacturing facility in Grangemouth, Scotland, UK, in December 2023.
The expanded facility increased Piramal’s ADC production capacity by 70% to 80%, as demand for commercial ADCs and early-phase clinical materials continues to increase. It also strengthens Piramal’s ability to serve more customers through the complete drug development lifecycle.
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Piramal Pharma Solutions invested approximately £45m ($60.85m) for the expansion, the groundbreaking of which took place in February 2022.
The expansion created between 40 and 50 new jobs at the Grangemouth site.
Location
Piramal’s ADC manufacturing facility is located on a 5-acre (2 hectare/ha) brownfield plot within Earls Gate Business Park, less than 100m from the existing site on Earls Road in Grangemouth, Stirlingshire.
It can be accessed from Roseland Hall Road, served by the A905 Beancross Road and Caledon Green.
Piramal’s ADC manufacturing facility expansion details
The expansion occupies an area of 1.92ha (4.7 acres) and included the construction of a new three-storey building for ADC bulk manufacturing suites along with associated buffer preparation, storage and support utilities. The ADC building has a gross floor space of 13,153m² (141,577ft² ) with a maximum height of 15.7m.
The first phase expansion added two ADC manufacturing suites to the facility, complementing the site’s three existing suites.
The facility is supported by analytical laboratories, including quality control, cell-based assay and enzyme-linked immune sorbent assay, and good manufacturing practice, along with warehousing, office space and supporting utilities.
The site expansion also included a new customer experience centre for clients who are visiting the site during development and manufacturing activities.
The facility is designed to accommodate further expansion in the future. Future phases of expansion are expected to include a sterile fill/finish suite dedicated to ADCs, as well as two additional ADC manufacturing suites that can handle large batch sizes.
Facility details
The expansion enabled the scale-up of commercial ADC manufacturing batches at the state-of-the-art, multi-product manufacturing facility, which is characterised by specialised or single-use product-contact manufacturing components.
In addition, the facility is equipped with an ISO 5 filling area and ISO 7 processing area along with good manufacturing practice production suites for clinical and commercial manufacturing.
Another notable feature of the facility is ADCelerate™, the company’s branded solution for the quick early-stage development of ADC drugs.
The solution enables the development of monoclonal antibody, conjugation, linker/payload and sterile fill/finish into a single integrated programme across global Piramal sites including Grangemouth. It enhances the site’s capacity to manage the entire lifecycle of ADC development and manufacturing.
Financing details
Scottish Enterprise, Scotland’s national economic development agency, provided a grant of £2.4m for the project.
Piramal Pharma’s ADC capabilities
Piramal is a leading player in ADC contract development and manufacturing offering integrated end-to-end services. Its capabilities include conjugation development, clinical and commercial good manufacturing practice batch manufacturing, and sterile fill/finish services.
The company’s new facility produces low-bioburden ADC products on a contract basis for pharmaceutical companies. It increases Piramal’s research and development and production capacity to help in the development, scale-up and commercial manufacture of drugs for the treatment of cancer.
Every year, between 46 and 69 batches are expected to be produced, with a potential to reach 80 on completion of the final phase of expansion.
Contractors involved
Piramal awarded a £30m contract to Merit Health, an engineering and construction company, to build the ADC manufacturing facility. Merit used its FLEXI POD® hybrid construction solution to construct the facility.
The new facility was designed by Integrated Project Services, an engineering, procurement, construction management and validation company based in the US.
Acies, a property and construction consultancy and a subsidiary of civil engineering firm RSK Group, provided civil and structural engineering services for the project. French engineering and consultancy group Systra Group provided transport consultancy services.
ECOS Countryside Services provided ecological consultancy services for the expansion, which included assessing its impact on local wildlife.
Scottish geo-environmental consultancy Mason Evans Partnership was selected to undertake site investigation works.
Flood Kaya Consulting, a provider of flood risk assessments, hydrological studies and environmental impact assessments, was selected to conduct a flood risk assessment for the expansion.
Scotland-based consultancy firm Ironside Farrar was selected to prepare the environmental impact assessment report for the project.
