India-based Kemwell has shown eagerness in biologics manufacturing and joined hands with Boehringer Ingelheim to construct a biopharmaceutical production facility that will feature a 2,500 liter vessel for cell culture. With an investment of $51 million, the GMP compliant facility is scheduled to be completed in 2012. The new Kemwell Biopharma facility of 15,000 sq m will be designed for process development, production, purification and formulation of biologics for early-phase preclinical and clinical studies. It will also consist of a cGMP drug substance manufacturing facility.

Mr Sanjay Lodha, senior director, operations, Kemwell, says India's rising prominence in the field of biologics, specifically in biosimilars, is evident from the fact that the highest number of biosimilar products from India have received marketing approval. In terms of volume, India is the world's second largest supplier of childhood vaccines and fourth largest supplier of pharmaceuticals.

Another leading company from India, Shantha Biotechnics, is into manufacturing of vaccines and biotherapeutics, both as bulk and finished products to be sold in the market. Shantha's facilities qualify the standards set by Indian regulators and the World Health Organization, enabling it to export products to several countries. Very recently, the company also obtained WHO approval to manufacture and commercialize its whole cell cholera vaccine Shanchol.

Dr Harish Iyer, CEO, Shantha Biotechnics, India, says the biotech industry in India is still in its nascent stage, but growth has been rapid. "Shantha is one of the top companies that are involved in biologics manufacturing in India. Overall and across companies, the level of investment in manufacturing has been significant. There have been several new products in the biotech sector, both in the vaccine space and the biopharma space. The availability of vaccines made by biologics manufacturers, such as the hepatitis B vaccine, has made them more affordable for people. Additionally, the availability of biopharmaceuticals, such as interferon, erythropoietin and insulin, has also increased significantly due to stress biopharmaceutical manufacturing," he says.

Over the last couple of years, biologics sector in Korea too has witnessed rapid growth. In 2011, Celltrion signed an agreement with Novacell Technology to develop biosimilars, while Dong-A Pharma signed a memorandum of understanding with Pohang University of Science and Technology for co-operation on new biotechnology-based drugs. The same year, a seasonal flu vaccine by Green Cross also received WHO prequalification.