Alpha Biologics is an independent contract manufacturing organization, founded in 2003, specialising in mammalian cell-secreted proteins. Alpha Biologics offers US FDA/EU EMEA cGMP compliant services to the worldwide pharmaceutical and biotechnology industry. The company has process development laboratories in Cambridge, UK and has a cGMP manufacturing facility in Penang, Malaysia. The Penang facility also has process development/scale-up laboratories.
Process development is initially undertaken by Alpha Biologics’ experienced team in the Cambridge facility. This group prepares cell lines and develops upstream and downstream processes for transfer into the cGMP facility in Malaysia. The team in the UK also provide process development for other expression systems, from cell line development through to scale-up.
The Penang facility has the state-of-the art, bespoke processing equipment, monitored 24 hours by an internal Data Management System. The are seperate areas for analytical development, quality control and engineering functions.
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Locations
Alpha Biologics Manufacturing Facility
Plot 302 Penang Science Park
Taman Peridnustrian Bukit Minyak
Seberang Perai Tengah,
Penang 14100
Malaysia,
Asia
GMP Experience
Experienced expatriate staff with many years of cGMP in Europe, India and America. Facility compliant with US-FDA, EMEA and PIC/s guidelines. Will be undergoing PIC/s accreditation procedures Q2 2010.
Alpha Biologics PD, UK
Alpha Biologics Ltd
Babraham Research Park, Babraham
Cambridge,
CAMBS CB22 3AT
United Kingdom,
Europe
GMP Experience
Experienced staff in cGMP acitivities in the UK. Responsible for all technical transfer acitivites for projects and assistance with cGMP documentation for Penang facility.
Alpha Biologics Manufacturing Facility
500L
Alpha Biologics Manufacturing Facility
250L #1
Alpha Biologics Manufacturing Facility
250L #2
Alpha Biologics Manufacturing Facility
70L