cGMP Manufacturing Facility

The cGMP manufacturing facility in Penang, Malaysia was designed by an experienced team, collectively responsible for many plants around the world that have undergone successful FDA / EMEA audits and are fully approved manufacturing facilities.

Built in 2007-9 and commissioned in 2010, the Penang cGMP manufacturing facility's design was reviewed by the by the FDA and declared suitable for both clinical trial and early market product manufacture. It incorporates a flexible layout that can be adapted to perfectly suit the client's process design and cGMP manufacturing needs. Click here for information on facility's process plant and technical statistics.

The cGMP manufacturing facility has bioreactor capacity from 10 to 500 litres. Its cutting-edge design allows shortening of the process development and manufacturing process - sometimes by many months - resulting in significant cost reductions for clients.

For example, the facility has three separate Isolation Suites, so that we can initiate product / cell line work prior to the cell line being confirmed as fully characterised and ready for the production of clinical grade material. This includes the development of Master and Manufacturing Working Cell Banks and small scale product manufacture for use in pre-clinical studies.

There are also separate but parallel Upstream and Downstream process halls where work can be undertaken in the same equipment, thus minimising technology transfer risks and delays to the cGMP manufacturing process. Click here for information on Upstream and Downstream processing capabilities.

Alpha can work with clients to either adapt a well developed manufacturing process, or develop a new process from early research phase.

Good Manufacturing Practice: Alpha's team has many years of experience of designing and operating mammalian cell contract manufacturing and in-house manufacturing facilities in compliance with cGMP. They are experienced at working with the regulatory authorities in both Europe and the US to ensure successful facility audits.

Alpha's cGMP biomanufacturing facility was designed in compliance with both FDA and EMEA guidelines. The design has been favourably reviewed by the Centre of Drug Evaluation and Research (CDER) at the FDA, with advice from CDER duly incorporated into the final design. The facility is currently preparing for EMEA and PIC/s audit with an initial independent audit inspection in April 2010.

Contact us on +44 (0) 1223 496070 (UK), +60 (0) 4 5048800 (Malaysia) or info@alphabiologics.com for a quotation or further information.

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