Kemwell, the dedicated contract manufacturing major's advanced biopharmaceutical facility is in its final lap of completion for which the company had started construction in 2009 investing around Rs.250 crore to tap the burgeoning opportunities in the global biologics market.

The new facility is reportedly being made with state-of-the-art research, development, pilot plant, and manufacturing capabilities meant to help its contract research and manufacturing-oriented clients to grow their businesses.

Global CRAMS business is growing substantially as customers are increasingly focusing their internal efforts on research and marketing. The pricing pressure from governments and onslaught of generic competition are also increasing the outsourcing efforts of customers, Anurag Bagaria, chairman and managing director, Kemwell Biopharma told Pharmabiz.

“We are ready with process development and analytical labs and will be commencing work for one of our customers in July. The manufacturing units for Fill and Finish and the GMP compliant drug substance production facility for monoclonal antibodies (MAbs) are now undergoing validation and will be ready by year end,” he added.

The Fill and Finish facility will be commissioned in October this year and will cover drug production in vials and pre-filled syringes including lyophilization. The GMP compliant drug substance facility for the manufacture of MAbs is equipped with two cell culture bio-reactors of 2000 litres and will be operational by December this year.

The advanced biopharmaceutical production plant which is located at Nelamangala in the outskirts of Bengaluru spans over an area of 150,000 sq feet and the core capabilities of the facility cover process development, clinical trial material (CTM) manufacture, commercial product supply, analytical development and stability studies for Mammalian Cell Culture products.

Developments at the company in the last one year included completion and commissioning of the new pharmaceutical development labs, both GMP and non-GMP, in Bengaluru and a new manufacturing facility in Sweden. The oral solids facility in Bengaluru is preparing for the first FDA PAI (pre-approval inspection) this year and is already approved by the EMA, TGA, MCC, MHRA and Health Canada.

“Our first facility at Uppsala, Sweden is doing well and so is newly commissioned facility which is adding customers and products at a rapid pace. The facility is already approved by the EMA and transfers of various products are going on,” he said.

In May 2011, Kemwell had signed an Memorandum of Understanding (MoU) with Avesthagen for the large scale manufacture of biosimilars for which the technology transfer is under discussion.

Plans to take the Kemwell growth forward are now focused on filling up the capacities at the two locations in Bengaluru and Sweden. “We will continue our focus to provide manufacturing services and would not enter into developing our own products. We are also looking at acquisitions in both development and manufacturing businesses in the US, European and Asian markets,” stated the Kemwell chief.