Contract biologics manufacturer Alpha Biologics (www.alphabiologics.com) capitalizes on the benefits of a dual operation—European headquarters and process development facilities and Malaysian manufacturing sites. The company says that this translates into more cost-effective manufacturing for clients while retaining the scientific, process development, and project management capabilities of a European base and expertise.
Alpha is based in Cambridge, U.K., and is building a 5,000 m2 mammalian-cell-production plant in the Penang BIOtech Park in Malaysia. The company believes that the facility will be ready for FDA/EMEA cGMP-compliant operation during early 2008.
The concept of transferring biologics manufacturing to countries such as Korea, India, Singapore, or China has been embraced by a number of international CMOs but can be fraught with issues, explains Jon Mowles, Alpha’s European commercial director. “Transferring projects lock, stock, and barrel to the far east can throw up many problems with respect to organizing face-to-face meetings with clients,” warns Mowles, also founder of CTM BioTech, the process development company bought out by Alpha during early 2007. “Language and basic distance barriers can also make clients feel like they have lost control of their project.”
Alpha aims to negate these problems, he continues, by carrying out all scientific research and early development work at its European facility. “Cell line selection and storage, along with scale-up, process development, and non-cGMP preclinical production are carried out in the U.K. on identical equipment to that in Penang. Our director of process development oversees teams of dedicated staff both in the U.K. and in Malaysia, and constant liaison with our expatriate-led Malaysian teams means technical issues are minimized, allowing seamless transfer of the project to Malaysia for cGMP manufacture.”
In addition to carrying out all process development, the U.K. site also acts as the training facility for the Penang staff, Simon Saxby, Alpha’s CEO, points out.
The Penang site, constructed to an FDA-approved design, is dedicated to the production of mammalian-cell-secreted proteins. The facility includes three isolation suites for USP-cell banking, bioreactor seed, or manufacturing. Stirred tank vessels, ranging in volume from 10 to 500 L, are combined with perfusion technology where practical. Alpha believes that this will significantly increase productivity per vessel. The facility also includes two separate DSP suites and separate final filtration/viral removal suites.
“Malaysia actually represents an ideal geographical location for biomanufacturing,” Saxby comments. “The country has a very well-educated population, and English is commonly spoken. The administrative and legal set-ups are very much in line with those in the U.K., and there is also significant Malaysian government support for the bioindustries. These factors, combined with far lower operating costs compared with those in Europe and North America, will allow us to significantly reduce manufacturing costs for our clients, while ensuring they receive the same quality of service and cGMP manufacturing and maintain control of their projects.”
Although focused on mammalian cell culture processes, Alpha also has significant expertise in microbial- and yeast-based systems at its U.K. facility. The Cambridge plant can provide up to a 50-L fermentation capacity for prokaryotic systems and for production utilizing baculovirus or yeast expression. The company also has links with other CMOs for nonmammalian cGMP manufacturing.
Alpha is confident that this business model, providing a new opportunity for the biopharma industry by leveraging the strengths of different geographical locations, will prove an attractive option to a market sector that is increasingly looking to outsource their production requirements.