Almac Clinical Services, a unit of Almac Group, announced it has successfully undergone an inspection at its European campus in Dundalk, Ireland, resulting in a good manufacturing processes (GMP) compliance certification from Ireland’s Health Products Regulatory Authority (HPRA).
During the inspection, the HPRA examined the company’s suites and associated processes at the facility. The authority noted no deviations, while it also updated its manufacturing authorization to include secondary packaging capabilities.
The compliance regards the company’s Almac Adapt services. The program launched in June 2019 and is designed for time-sensitive medicine supply, including cell and gene therapies, oncology trials, immunotherapy, rare and orphan diseases.
Natalie Balanovsky, manager of the Just in Time Manufacturing Solutions division, told us that the service looks to address the ‘changing’ needs of the industry. When asked about how this is changing, she explained the industry is experiencing a rapidly growing and ageing population, to which science responds by developing personalized medicines.
Almac Adapt aims to enable customization of clinical supply, by postponing packaging and labelling until the site or patient’s need arises, with operations triggered directly by distribution orders.
According to the company, this method ensures finished patient kits are packaged, labelled and shipped only when needed, to reduce timelines, wastage and product shortages to ensure budgetary and protocol efficiencies.
Development of the service, as well as of the facilities that offer the same, has cost the company an investment of more than $5.7 million (£4.4 million). This figure includes expenditures at Almac’s sites in Craigavon, UK; Dundalk, Ireland; Pennsylvania and North Carolina, US; and Singapore.
Almac obtained the Ireland facility in 2017 and expanded it in 2018, as part of the company’s strategy to address challenges that may arise due to Brexit. To date, Balanovsky told us, the site has empowered Almac to provide services to its customers, “guaranteeing seamless access to the European Union post UK withdrawal.”