Almac Addresses Industry Demand for Multiparticulate Drug Products
In response to increasing client demand for multiparticulate drug delivery systems, Almac Group is providing fluid-bed processing and encapsulation services to its global partners from its UK development and commercial manufacturing facilities.
Multiparticulate systems — including pellets, beads, granules and mini-tablets — are typically formulated to optimize drug performance, enhance patient tolerance and safety and extend patent protection. Development and scale-up of these dosage forms can be challenging, however, Almac’s clients are seeking the technical expertise and equipment capabilities that provide scalable solutions.
Almac’s most recent addition in multiparticulate technologies is focused on commercial-scale support. Almac has qualified both a Glatt GPCG PRO 120 fluid bed processor and an IMA Adapta 100 high speed encapsulator. The Glatt accepts modular inserts for each of the three common fluid bed processes: bottom spray, top spray or drying.
Most recently, Almac’s development and commercial teams have successfully registered and commercially manufactured a product at 250kg scale using the bottom spray Wurster insert. Utilizing the dedicated fluid bed drying / encapsulation suite, multiparticulates from those batches were then filled into capsules using our Adapta 100, which has a high throughput capacity of up to 100,000 capsules per hour and an integrated online checkweigher with feedback loop to maintain high yields.
As John McQuaid, VP Technical Operations at Almac, explains “Having both small and large scale fluid-bed and encapsulation technologies allows us to meet our clients’ needs for multiparticulate drug products from early phase clinical supplies through to ongoing commercial demand. Our clients benefit from a single-partner and single-site approach that eases tech transfer, provides scientific continuity and delivers savings in terms of both time and cost.”