Rubicon inaugurates the first CTS facility in India
Our News Bureau – Mumbai
Dr Pratibha Pilgaonkar
inaugurates the seminar
Rubicon Research, a product development and drug delivery company, held a seminar on ‘Clinical trial supplies-Challenges and opportunities’ to mark the inauguration of its cGMP Clinical Trial Supplies (CTS) facility at Ambernath (50 kms from Mumbai international airport) on August 19,2008. The event comprised of scientific and business sessions delivered by various global industry leaders.
Key speakers at the event were Professor Clive Wilson, University of Strathclyde, Glasgow, Scotland, who spoke about the value and critical nature of clinical trials; Gopal Pai, Neuromolecular Pharma, who discussed the various outsourcing strategies in CTS; K V Subramanian, President and CEO, Reliance Life sciences, who addressed the global issues plaguing the biotech and pharma industry; and Nitin Deshmukh, CEO-Private Equity, Kotak Mahindra Bank, who provided an insight into the growth of Indian biotech industry in 2008.
Rubicon’s CTS facility can accelerate the vertical integration Rubicon’s business model in the area of formulation development, allowing the company to speed up product development lead times from product development to pivotal batches manufacturing required for product registration. It will also allow submission of CMC data for any NDA/sNDA/ ANDA applications, thus eliminating the need of technology transfer to other companies thereby protecting the intellectual property. Clinical trials supplies can be organised for multicentric trials in a structured way from this facility.
Earmarked for future expansion, the facility has been built in consultation with a US regulatory agency and is designed to meet US FDA/MHRA regulatory norms. This is a first of its kind facility in India, offering the entire gamut of clinical supplies, from clinical manufacturing to clinical trial material (CTM) depot. Through this facility, Rubicon also would extend expertise and services for its clients in the current core areas of formulation development, analytical development, stability studies and technology transfer.
Other than being a stop shop for clinical supplies is its flexibility to manufacture batches from development quantities (less than 5 kg batch size) to 1,00,000 units (120 kg batch size) and its containment suite to handle NCEs and high potency compounds along with packaging capabilities to accommodate complex CTS requirements like blinding, randomisation, patient packs.