Millipore India's Access Lab having the first integrated validation and process development services facility serving the pharma-biotech industry will now further bolster its activities in the country. The lab which completed five years in India has proved its economies of scale, time line deliveries besides easing the communication and coordination hassles for companies. Now it will step up its assistance in the area of stringent global regulatory compliance.

The lab in Bangalore which was set up at a total cost of Rs.4 crore will see further expansion. Details of the additional infrastructure and fund infusion were not made available.

The expertise includes filtration, purification, process development and process optimization for the development and manufacture of sterile drugs, vaccines and difficult to manufacture biologics. More than 30 top biopharmaceutical companies have accessed the expertise for filter validation and process development services.

Since its inception in 2004, customers have been supported with development of downstream processes for over 10 biotech products. Around 750 pharma-biotech customers are trained at the Advanced Pharmaceutical Filtration schools on aseptic processing, process monitoring, biotechnology processes, updates on regulatory affairs and emerging trends and technologies in flexible bio-processing and single use solutions.

Projects that used to take 6-9 months to complete in labs abroad are now being done in Bangalore where experienced teams are equipped to deliver results in 45 days to three months depending on the scope of the project.

The Lab has made a measurable difference to the quality of consultancy available in the country. With increasing regulatory pressures to protect the integrity of biopharmaceutical processes, safety of final drug, and the cost pressures on R&D/manufacturing productivity, the lab has performed a critical role for companies to speed up regulated market entry initiatives, stated Sudhir Kant, president, Millipore India.

For Millipore Corporation, the Access Lab in India is the fourth facility after Billerica (US), Molsheim (France) and Yonezawa (Japan). All labs have the same protocols, training sessions and there is no difference in terms of infrastructure and expertise with regular interaction.

Apart from compliance with worldwide Millipore standards and processes, companies have benefited from the range of QA/QC services and studies like extractable, bacterial retention, product integrity, filter compatibility and preservative binding tests. There is also domain expertise in monoclonal antibodies (MAbs), manufacture of biologics, recombinant proteins, sterile active pharmaceutical ingredients (APIs) as major Indian manufacturers have partnered with Millipore. Other emerging areas where the company is taking the early initiative is flexible bioprocessing solutions, mycoplasma, and rapid microbiology.