Dalal Mott MacDonald to help develop India's first biotech drug plant

Indian engineering consultancy Dalal Mott MacDonald has been appointed by Shreya Biotech to help develop a facility to manufacture biopharmaceuticals in Pune, India.

The £4m plant is the first of its kind in India to employ both the bacterial as well as mammalian cell culture routes to produce biotech drugs.

The facility will produce a range of products using the recombinant DNA technique for the bacterial fermentation route and the mammalian cell culture for other products. The rDNA route will initially be used to produce human insulin, while the mammalian cell culture route will be used to produce the hepatitis B vaccine.

India currently has the world's largest population of diabetics, with an estimated 30m people suffering from the disease. According to the WHO, this figure is set to reach 57m people by 2025, virtually doubling insulin demand. The bulk of insulin currently sold in India is porcine insulin extracted from pancreases of slaughtered animals. The recombinant DNA derived human insulin produced in the plant will have greater acceptance and reduced risks.

The facility will have clearly demarcated suites for inoculum preparation, fermentation, downstream processing including isolation and purification as well as lyophilisation and formulation for the individual streams. Associated functional blocks for buffer preparations, CIP stations, cold storage, water systems as well as warehousing and plant utilities are being designed to ensure compliance to prescribed international regulatory approvals.

Dalal Mott MacDonald's role involves scale-up of the process plant, basic and detailed engineering services, procurement assistance, qualification of premises, equipment, utilities and plant validation to achieve US FDA compliance. The plant will be completed by the end of 2004.