The Ahmedabad based, Celestial Biologicals Ltd, wholly owned subsidiary of Intas Biopharmaceuticals Ltd, plans to invest more than Rs 100 crore for setting up a plasma fractionation facility in Ahmedabad. The construction work of the new facility has already begun and it is expected that the full fledge operation of the facility will commence by the end of 2010.

Celestial Biologicals's plasma fractionation facility will be tailor-made to suit the Indian conditions. For the initial stage the manufacturing unit will have an installed capacity to fractionate 1,50,000 litres per annum of plasma. And company is aiming to scale up this capacity up to 3,00000 litres per annum after the commencement of facility. This unit will include collection, testing and storage facilities along with other subsidiary utilities.

The company will have plasma fractionated into a number of blood products including albumin, gamma globulins, blood-typing sera, clotting factors for people with haemophilia etc. The plasma fractionation process starts with recruitment and screening of blood donors. The screening process includes the review of donor's medical history, health practices and a comprehensive physical examination. Each unit of plasma is individually screened for anti-HIV 1 & 2, HBsAg and VDRI. In addition, special virus inactivation methods are used to ensure safety of products. Every step of all the procedures is in compliance with good manufacturing practices and the final product undergoes strict quality control before its release for human use.

Speaking to Pharmabiz, Ranjit Ajmani, chief scientific officer said, "We are in the process for setting up plasma fractionation facility in Ahmedabad. The laboratory facility has been already set up and the implementation of the facility will enable Celestial to leverage its inherent strengths in the area of biotechnology and transfusion medicine and research. The company has imported latest plasma machinery from Western Europe. Currently, we have manpower strength of 25 and it is expected that same will reach up to 80 in next one year. We are negotiating with couple of European and North American companies, to acquire the Plasma fractionation technology".

The manufacturing unit will also enable expansion of its product range by extracting other plasma proteins from source plasma, including Albumin, Immunoglobulin and Coagulation factors, once parameters such as yields, fractionation charges, market demand, and pricing are established for these products. Celestial is actively engaged in marketing of plasma products - Albumin and IVIG - under the brand name 'Albucel' and 'Globucel' in India.

The company has received permission from DCGI for accessing plasma. At present Celestial is collecting plasma from 25 blood banks across India. The company has entered into a contractual agreement with South-Korea based Green Cross Corporation for fractionation of plasma. The company has obtained all the requisite regulatory clearances. Till date it has shipped more than 18,000 litres of plasma to South Korea for fractionation. "We have received marketing approval from DCGI for fractionate. We will be launching fractionate in India soon. In future we are targeting to make India as a hub of plasma fractionation business for the entire South East Asia.", Ajmani added.

The plasma fractionation units are popular in the west. "The company will be relying on contract fractionation till its own facility starts functioning. In the meantime, Celestial Biologicals will be engaged in improving the regional networks of trustworthy blood banks", said Mani Iyer, executive director.