Crossing the Rubicon

Starting out as a one- stop-shop for all formulation development needs, Rubicon Research has plans to enter the clinical trial supplies (CTS) packaging segment. Usha Sharma spotlights the company.

Most people avoid risk, but the truly confident embrace it. Rubicon Research, a Mumbai-based contract research organisation (CRO) focussed on oral solid dosage forms and a dispersed system, embraced risk and is now poised to reap the rewards.

The company is named for a line which protected a town from the attacking Roman army. The phrase ‘crossing the Rubicon’ has come to refer to a person (or organisation in this case) who commits to a risky course of action. When the founders, Maharukh Rustomjee and Sudhir Pilgaonkar started in 1999, the industry norm was to specialise in a single service area, say product development or contract manufacturing of proprietary drug delivery technologies or clinical supplies, which included clinical manufacturing, packaging and distribution. The founders however, decided to offer all these services under one roof. This was a risky business proposition for a new start-up. But though Rubicon was new, between its two founders, it had more than half a century of pharma experience. Nine years down the line, both founders, as Chief Operating Officer and Chief Commercial Officer, are actively involved in the company’s plans.

The first steps …

Starting out with just three scientists in a 2000 sq ft laboratory in 2000, the company undertook its first ‘Clinical Trial Supply’ assignment for an MNC exactly one year after inception. As business grew, and in anticipation of further growth, thanks to the booming clinical research and contract manufacturing industry in India, the company shifted to independent premises in 2002 in Bhandup, a suburb of Mumbai.

In 2003, Rubicon passed a major milestone when the Directorate of Science and Technology, Government of India approved the facilities as a commercial Research and Development (R&D) company. “Our Government has taken lot of initiative for encouraging R&D oriented companies. Its initiative helps out for tax incentive, which promotes to companies R&D activity. Definitely, we have also got tax incentive from government which brought our balance sheet healthier. The same year, the company also filed its first international patent for natural speciality techniques

The achievements continued with 2004 seeing the first controlled release product licensed to a US customer and the first international co-operative venture for developing products followed a year later. While in 2006-07 Rubicon has finalised its agreement with Mallinckrodt Baker.

In August this year, the company inaugurated its Clinical Trial Services (CTS) facility, at Ambernath, which is conveniently located 50 kms from the airport, a key attraction for time-bound consignments.

Versatile action

The company is involved in formulation development, right from the initial stages of Intellectual Property (IP) evaluation, feasibility studies, pre-formulation and formulation development, New Chemical Entities (NCE) product development, to analytics, stability management, and clinical trial supplies including manufacturing, packaging and distribution. Rubicon has developed platform technologies that address the commonly occurring formulation problems in a cost effective way. “We have developed several products based on these technologies and can offer the same for out- licensing”, says Pratibha Pilgaonkar, Chief Executive Officer, Rubicon Research.

Rubicon provides a gamut of services to pharma companies, from innovator brand companies, specialty companies, to generic companies, CROs and other cosmetic and nutraceutical companies. It is also involved in formulation development for NCE companies for pre-clinical development, feasibility studies, formulation development and supplies for clinical research.

“We can support formulation development and pre-formulation development for IND submissions and also conduct formulation optimisation exercises for drug discovery companies. We have worked with the biggest pharma companies, as also with small start ups. Under contract research, we give services like pre-formulation studies, NCE product development, solubility services, stability testing services, technology transfer and regulatory support,” Pilgaonkar adds.

The company believes in applying first the principles of science to formulation development and offers a complete basket of services under formulation development ranging from IP evaluation to technology transfer and clinical trial supplies. In this, it has been very successful thanks to the technocrat-founders, who have years of experience in formulation development for regulated markets.

In formulation development, Rubicon has a presence in all therapeutic areas excluding cytotoxic drugs, beta-lactum antibiotics and steroids. It also provides analytical development and validation services and stability testing chambers as per ICH guidelines and can support stability studies across all temperature and humidity zones. “We have an in-house IP cell that evaluates the IP scenario for the formulation being developed and drafts a formulation development strategy. We have technology transfer as an integral part of services and our scientists go to the clients’ manufacturing location to conduct technology transfer,” Pilgaonkar comments. It allocates a separate team for each client, which act as an extended arm of the client’s R&D infrastructure.

Manufacturing facilities

As a vertical expansion of its existing R&D facility at Bhandup, which houses formulation development activities, analytical development and validation, and stability chambers, Rubicon now offers the next step in the pharma value chain: CTS. According to the company, this CTS facility is a first of its kind in India, offering the entire gamut of clinical supplies, from clinical manufacturing to a Clinical Trial Material (CTM) depot. This new facility offers the same expertise and services in its core areas

of formulation development, analytical development, stability studies and technology transfer. Its CTS facility has a built up area of 6,500 sq mtrs, which is around two thirds of the total land available for development. The facility, built to conform to current Good Manufacturing Practice (cGMP) norms in consultation with a US regulatory agency is designed to meet US FDA and EMEA regulatory norms. “Our Ambernath facility still has a lot of spare capacity for expansion and in future, we would be expanding into newer areas like topicals, liquid orals and injectables,” reveals Pilgaonkar.

The Unique Selling Proposition (USP) of this facility, other than being a one stop shop for clinical supplies, is its flexibility to manufacture batches from development quantities (> 5 kg batch size) to 100,000 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 etc.

“At present our total manpower strength exceeds 140, including 120 scientists. We are rapidly expanding and are recruiting for our CTS facility. We expect to touch strength of 200 by the end of 2009,” she adds.

Recently, Rubicon licensed its Orodispersible excipient, RubiODT to Mallinckrodt Baker, Inc, a leading specialty chemicals company from USA. Rubicon is present in US and UK, with a client list including; Novartis, Pfizer India, Solway Pharmaceuticals Netherlands, Collegium Pharmaceutical, Combinator, NeuroSci, Siegfried Generics, Bioglan Niche Generics, Hindustan Lever etc.

Looking ahead, Pilgaonkar says that Rubicon’s service offerings will expand further to include more drug delivery systems and dosage forms manufacturing as well as packaging for clinical trial supplies from their CTS plant which has spare capacity.

usha.sharma@expressindia.com