Aesica Containment Facility, United Kingdom

Aesica, a supplier of active pharmaceutical ingredients, broke ground on a new high-potency facility at its Queenborough site on 17 August 2010. The new facility will allow Aesica to expand its formulation offering in the growing market for contract manufacturing of high-potency drugs.

The facility will increase the company's formulation and packaging capacity of liquid and solid dosage forms. It is scheduled to begin operations by May 2011. Aesica is investing €3m ($4.6m) towards the construction of the facility, which is expected to be completed in November 2010.

Located in Isle of Sheppey, Kent, England, the Queenborough facility was acquired by Aescia from Abbott Laboratories in September 2007. The deal, which included a five-year supply agreement with Abott Laboratories, tripled the workforce of the company, boosted capacity and took Aesica into secondary manufacturing.

Facility

The new high-potency facility will house multiple suites for granulation, tabletting and blister packing. All the suites will be equipped with appropriate heating, ventilating, and air conditioning (HVAC) and cleaning facilities. To avoid any occurrence of cross-contamination, the facility will be a segregated unit constructed at a distance from the remaining facilities of the company.

The company says that the design and construction of the purpose-built facility will be in conformance with environmental requirements. The new facility will be equipped with security systems that will ensure the production of Schedule II controlled drugs including opiates.

The multi-purpose Queenborough facility is designed in compliance with ISO14001 standards. It is equipped with a range of capabilities including production of solid dosage forms, anaesthetics, and controlled medicines and packaging facilities that accommodate blister packs, sachets and bottles.

Technology

The Queenborough facility is equipped with a range of technologies including high shear granulation, low shear granulation, fluid bed drying, tray drying, blending, compression, bi-layer compression, tabletting with B&D tooling, film coating, liquid manufacturing, blister packaging, solid bottle filling, liquid bottle filling, sachet filling and capsule filling. Other technologies include those for control release, alcohol-based liquids and device assembly.

Production

The new high potency facility will allow Aesica to develop Schedule II controlled substances, potent active pharmaceutical ingredients (API) and intermediates that are classified as Category 3 by Safebridge Consultants, Liverpool UK. The new facility will boost Aesica's the production capacity of Schedule II compounds. Aesica began production of Schedule II compounds in 2009 after the approval of its Cramlington, Northumberland facility.

Compounds categorised as high potent are effective in treating a range of diseases at low doses.

The compounds, however, have to be produced in an environment equipped with appropriate safety measures.

The Queenborough facility specialises in the production of drugs containing APIs that require special handling needs including high potent medicines or controlled substances.

It currently manufactures a range of formulated products including anti-infectives, cardiovasculars, anti-virals, anaesthetics, anti-inflammatories, haematinics and hormones. The products are manufactured in solid dosage forms, liquid dosage forms, anaesthetics and potent drugs. The facility can additionally perform packaging in bottles, blister packs and sachets.

Capacity

The facility can operate at an annual wet granulation capacity of more than 500t, including low shear, high shear and fluid bed drying. Annual tablet production capacity including single, bilayer and film coating is more than 2bn. The facility can additionally manufacture 1.5m litres of liquid at non-critical temperatures and up to 300,000l of liquid at critical temperatures every year. Blister packaging capacity of the facility is 90m packs per annum.

The facility can also pack 15m bottles of solids including tablets and granules and 14m bottle packs of liquids every year.