AAI Pharma/Cambridge Major Laboratories adds equipment and capacity for drug product manufacturing

Installs upgrades at its plants in the US and the Netherlands

AAIPharma Services/Cambridge Major Laboratories (AAI/CML), a provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, now has additional capabilities and capacity for oral solid manufacturing at its Wilmington, NC facility in the US, which it says have been driven by significant growth in its drug product portfolio, particularly for orphan drugs and rare disease therapies.

The firm has also upgraded its small molecule manufacturing capabilities at its site in Weert, the Netherlands.

Some of the recent additions to the firm's oral solid capabilities in Wilmington include precision coating for its fluid bed dryer (GEA/MP-4), which allows for bottom spray coating for enteric release products. In addition, it allows top spray granulation and drying for materials from the (GEA/PMA-400) high shear mixer. The additional bottom spray coating capability was introduced along with an extruder spheroniser (GEA NICAS450/NICA140).

A Bosch KKE 1700 capsule checkweigher has also been added to increase encapsulation capabilities. With the addition of this equipment and a second manufacturing shift, AAI/CML has increased its solid dosage capacity by approximately 35%.

'Our facility upgrades in Wilmington for drug product complement the overall progress of our laboratory and headquarters expansions,' said Ted Dolan, Chief Operating Officer. 'We are excited to have this top-of-the-line equipment and added capability for specialised areas of drug product development and manufacturing.'

The new capabilities complement existing specialities such as minitabs, paediatric sprinkles, chewable products, sublingual tablets, orally disintegrating tablets, extrusion granules, and extrusion spheronisation.

In Weert, the firm has installed a DE Dietrich Agitated Filter Dryer for controlled isolation of Intermediates and Active Pharmaceutical Ingredients (APIs). The filter dryer, first introduced early last year (2015), provides a completely closed system unit for isolation and drying, which minimises operator exposure and provides a safer manufacturing environment.

'The investment in this technology has improved containment around isolation, enhanced the safety of our operating environment, and helped increase yields. Our highly active compounds can also be processed using this filter dryer with ancillary equipment, for customers that need additional protection for Occupational Exposure Limits (OELs),' said Dolan.

The DE Dietrich Agitated Filter Dryer also provides packaging efficiencies and the ability to re-dissolve using a second solvent within one system. The unit has a volume of 490 litres, a cake volume of 180 litres and a nominal filtration area of 0.6m2.

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