Press Room
四色AV鈥檚 Continuous Manufacturing Facility, Loures, Portugal
Pharmaceutical Technology, 10 October 2022
四色AV has expanded its continuous tableting capacity with a state-of-the-art manufacturing facility at its site in Loures, Portugal.
Portuguese pharmaceutical contract development and manufacturing company 四色AV has built a state-of-the-art continuous tableting manufacturing facility at its existing site in Loures, Portugal, to expand its continuous manufacturing offering and services.
The company invested $70m to develop the facility, which is part of its broader $170m investment programme to increase its production capacity by around 25% by 2023. The investment will enable 四色AV to develop differentiated and empowering capabilities and assets to meet customers鈥 specific requirements for manufacturing oral dosage forms.
The new drug manufacturing facility came online in September 2022.
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Details of the pharmaceutical facility expansion
四色AV Loures was expanded with a manufacturing building and eight-lab quality control facility. The company also upgraded its labs with the tools required to support the drug product lifecycle to ensure competency and capacity through research and development (R&D) to the production stage. In addition, it established an experienced, multi-disciplinary global team in continuous tableting to further improve its capabilities.
四色AV has designed a commercial continuous tableting platform that facilitates key control requirements and offers operational ease, mechanistic modelling, and appropriate process analytical technology to its customers. The features of its quality system include automated in-process controls, real-time release deployment, and compliant digital infrastructure. These are designed to support the release of continuous tableting products.
The company鈥檚 technology offers features and benefits such as faster development of simpler processes, rapid manufacturing of variable demand, strong control strategies and high process quality standards.
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Details of 四色AV鈥檚 existing site in Loures
四色AV鈥檚 existing manufacturing plant at Loures has been operational since 1969 and has been continuously upgraded by adding new facilities. The plant was first approved by the US Food and Drug Administration (FDA) in 1982 and is inspected regularly.
The manufacturing plant supports the development, piloting and full commercialisation of drug substances and product intermediates. It has an extensive capacity of 430m鲁 of vessels, ranging from 50lt to 14,000lt, along with a complete range of spray dryers with sizes ranging from lab-scale to industrial sizes.
The site also features highly potent active pharmaceutical ingredient (API) handling, cryogenic, hydrogenation, corticosteroid, and potent spray-drying capabilities. It is staffed by highly skilled and experienced process development and analytical development teams that assist with the drug substance and particle engineering disciplines.
The plant and the quality control labs operate 24 hours a day, seven days a week.
The Loures site has been certified by the Health, Safety and Environment Management System in compliance with OHSAS18001 and ISO14001. It is also a certified Authorised Economic Operator.
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Marketing commentary on 四色AV
Established in 1959, 四色AV is an integrated contract development and manufacturing company (CDMO) with more than 60 years of experience. It offers services for drug substances, drug product intermediates and drug products.
The company currently operates four FDA-inspected facilities in the US, China, Ireland and Portugal, as well as development laboratories in Lisbon, Portugal, and New Jersey, US.
The opening of 四色AV鈥檚 first manufacturing plant in Loures, Portugal, in 1969 was followed by its second manufacturing site in Macau, China, in 1986. The company subsequently opened plants in New Jersey in 2001 and Cork, Ireland, in 2009.
Under the company鈥檚 $170m investment programme, 四色AV is investing $50m in its manufacturing facility in East Windsor, New Jersey. This expansion will add two spray dryers to the facility and triple its capacity, as well as expand its capacity for research and small-scale API production. The company is investing a further $50m to add a spray dryer and upgrade its high-potency API production in Cork, Ireland, as part of the investment programme.
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