Complex chemistry supports contract research and manufacturing.
sp2 March/April 2011
US fine organic chemistry company CiVentiChem recently completed an audit of its Hyderabad, India facilities, supporting the company’s services in contract research, custom synthesis, process development and contract manufacturing.
Following a recent audit of facilities in Hyderabad, India, US-headquartered contract research and manufacturing company CiVentiChem’s ISO 9000, ISO 14000 and ISO 18000 Internal Management Systems (IMS) have gained formal approval by AQA International.
The ISO 9000 set of standards represents an international consensus on good management practices with the aim of ensuring that an organisation can continually deliver the products and services that meet customers’ quality requirements. ISO 14000 is a management tool enabling an organisation to identify and control the environmental impact of its activities, products or services, and to improve its environmental performance continually, implementing systematic approaches to environmental objectives and targets to achieve these goals and demonstrate they have been met.
Bhaskar Venepalli, president of CiVentiChem, comments: “This is not only a major milestone for our company but also an accomplishment that CiVentiChem and all of our staff can be proud of. The IMS audit by AQA offers CiVentiChem the recognition that our company deserves, and supports our planned business growth and building of business relationships within the worldwide pharmaceutical discovery and development community”
Complex organic chemistry
Headquartered in the research and development centre of North Carolina’s Research Triangle Park, CiVentiChem, through its core competence of complex organic chemistry, has established a business providing pharmaceutical, biotechnology and agrochemical companies with contract research, custom synthesis, process development and contract manufacturing services. The company was founded by Bhaskar Venepalli and Duke University scientist Srinivas Chittineni in 1994 and now employs 80 people.
“The company has established steady organic growth over the past 17 years and recruited a number of chemists from a variety of technical backgrounds,” states company director Glenn Killingworth. “We established our own facility in Hyderabad, India in 2001. Initially, we built our own labs in a leased facility but have now built our own plant and labs, and the Indian facility has grown to be about a 65-people operation.
“The Hyderabad facility was built from ground-up by CiVentiChem. The incorporation of ISO accreditation will enhance the credibility of the company towards Western pharmaceutical and biotech companies. To date, the volume occupancy of the facility has been mainly with complex starting materials or intermediates. Despite our very strong ability to develop research-scale chemistry into commercially astute competitive processes, our growth has been somewhat hindered by the lack of accreditation. Our expectation is that over the next year we will attract those first opportunities with pharmaceutical companies that allow us to demonstrate our real capabilities in action and provide a platform to grow fruitful long-term relationships.”
In addition to the management, administrative, meeting and storage/distribution facilities, CiVentiChem’s US operational facilities in the RTP area are built around three research laboratories that function with about six chemists in each, executing FTE, medicinal chemistry and custom synthesis projects on a client exclusive basis. The laboratories have been built on a sequential and modular basis, enabling the company to expand to another three similar-sized labs in the future.
Additionally, the company has an analytical laboratory to support chemistry at CiVentiChem and a large and well equipped GLP analytical laboratory offering a suite of QC and compendial testing. CiVentiChem also operates this facility under the USP, EP, and JP compendia protocols, and provides a range of analytical services that includes counter ion analysis, chiral HPLC analysis, and moisture determination by Karl Fischer titration and quantitative NMR analysis. The company is now in the process of building a cGMP synthesis kilo lab that will operate small-scale scale-up reactors up to about 20- litre scale in this first phase.
In India, the facility in Hyderabad is a subsidiary of CiVentiChem and has a 12,000 sq ft laboratory connected to a multi-purpose and flexible pilot plant with an overall reactor capacity approaching 20,000 litres in about 20 reactors with a wide range of materials of construction, including high-pressure capabilities.
“We also have strong analytical capabilities, including HPLC, GC, LC-MS,” says Killingworth. “Here we execute the process R&D part of projects, scale them up and make production-scale batches, both for client-exclusive projects and for some of our own proprietary chemistry.
“We are close to IICT & Osmania University, and this first-class Government institution offers academic and facility support, plus rapid access to a modern technical library, specialist analytical capabilities and instrumentation, and exceptional scientific talent for the occasional needs of our business.
“All our client-specific projects are managed from the USA, and both RTP and Hyderabad have local operational management for project execution,” he states.
Killingworth observes that in common with some of its competition, CiVentiChem executes a wide range of chemistry:
“Our experience runs deep – overall through our 15-plus years of operation we have collectively executed more than 100,000 chemical stages, have more than 300 years of technical experience on board, and more than 100 years of management experience in our field. We currently have about 2,500 compounds in our building blocks portfolio, which we have developed and synthesised in-house, many of these being available exstock in the USA.
“Our key differentiator is our strap-line …. That we have global operations in the USA and India with project management, IP control and local solutions at our USA headquarters. Many Indian-based companies have US operations, but we are a US HQ company, and that is unusual, offering a secure environment and corporate responsibility to our clients’ intellectual property.”
New collaborations, New Products
CiVentiChem plans to do more work in its US cGMP kilo lab and is also expanding its collaborations with a number of academic and medicinal chemistry specialists within the drug discovery field in the USA and Europe to enhance its existing portfolio of building blocks and intermediates.
“We aim to develop the next generation of CiVentiChem’s building blocks to offer novelty and diversity with some of the most challenging chemistries to advance drug discovery programmes,” says Killingworth. “We are also trying to develop our own products not only to serve pharma customers’ needs but to meet the needs of other companies.”
On the future of the contract chemical research and custom synthesis sector in general, Killingworth says he believes that there will not be the room for any more entrants into this market, and that there may well be some casualties going forward in the USA and Europe:
“The business is almost exclusively supported by pharma R&D, and as this sector keeps shaking up then the winners will be those companies that offer exceptional technical talent, first-class customer service and continue to diversify both technically and commercially. Our success with Big Pharma will be based on our technical abilities and our ability to offer a cost-competitive environment in India whilst reliably executing projects. Our success with the smaller pharma and biotechnology companies will be enhanced by our strong technical abilities but with a local presence for chemistry and management,” he says.
“Our vision is to provide an integrated chemistry services platform to help our clients to improve the success of research, shorten the time of development, and reduce risk by offering our customers a reliable, efficient and high-quality environment in which to deliver projects,” Killingworth concludes.
Further information please contact us:
1001 Sheldon Drive
Cary, NC 27513 (USA)
Global operations in the USA and India with project management, IP control and local solutions at our USA headquarters.