07 Mar 2012, BioSpectrum Bureau , BioSpectrum
Entry of multinational companies has been a big boost to Asia's position in biologics manufacturing, especially with cGMP compliance. Singapore has been way ahead than others in attracting global biopharma manufacturers and is home to many leading companies. Lonza's mammalian cell culture plant for contract manufacturing in Singapore has four mammalian bioreactor trains, each with a flexible capacity up to 20,000 liters. Slated as Lonza's second large-scale mammalian cell-culture facility, the facility represents an investment of approximately $250 million.
Another global giant, Novartis is constructing cell-culture production facility in Singapore, which is due for completion by 2012, to support its growing pipeline of biopharmaceuticals.
Taking more interest in Asia, Lonza has invested in the Genome Valley of Hyderabad, India, and is building a small-scale multi-purpose manufacturing plant for biopharmaceuticals and a small-scale bio-therapeutic media manufacturing plant there. Phase I of the entire project is scheduled to be operational in 2012-13.
Exploring the avenues of biologics manufacturing, Australia has attracted US-based DSM Biologics to design, build and operate the first major Australia-based mammalian biopharmaceutical manufacturing facility, which will be located in Brisbane. Over 70,000 square feet facility will offer mammalian process development and cGMP clinical and commercial manufacturing services. The new contract biologics manufacturing facility is scheduled to be operational in 2012.
Korea has been successful in making global companies outsource biopharmaceutical production to its local companies. In 2011, Bristol-Myers Squibb (BMS) signed an agreement with Celltrion for manufacturing biopharmaceutical products, including its abatacept and belatacept products. Celltrion is one of the largest biopharmaceutical manufacturing facilities in the Asia Pacific region, with a large-scale cell-culture contract manufacturing facility and approval from the US FDA. Celltrion is also planning to expand the production facility to 150,000 liters of capacity. Celltrion has also formed a partnership with Hospira, a global biosimilar producer.
Malaysia's InnoBiologics Biopharmaceutical is in a 10-year collaboration agreement with Boehringer Ingelheim for biologics manufacturing since 2009. InnoBio has a manufacturing facility for mammalian cell-based expression system (200 L and 1,000 L) and it is certified as compliant to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S). They are two international instruments between countries and pharmaceutical inspection authorities that provide an active and constructive co-operation in the field of GMP.
The company believes that InnoBiologics and Boehringer Ingelheim's smart partnerships ensure effective capacity utilization and smooth technology transfer for customers who decide to transfer production to big contract manufacturing organizations for large-scale production.