Drug maker relies heavily on contract manufacturer
By Staff -- Purchasing, 11/18/1999
Development of new pharmaceuticals has changed dramatically over the past few years. At one time, drug makers relied mainly on their own internal resources for research and development of new pharmaceuticals. But cost pressures and the increasing importance of time-to-market in the pharmaceutical marketplace has made relationships between drug makers and contract manufacturers critical to commercial success of new drugs.Searle, a division of Monsanto, relies on a combination of in-house production and contract manufacturing to produce the quantities of active pharmaceutical ingredients (API) that are required for pre-clinical studies and clinical trials at specific phases of the drug development process.
According to Russell Buchman, director, global sourcing for Searle, criteria that Searle looks for in its contract manufacturers includes:
- Competent technical staff.
- Appropriate production equipment.
- Flexible production capacity.
- State-of-the-art environmental, health, and safety practices.
- Experience with good manufacturing practices (GMP).
- Acceptable costs.
- A strong customer-service attitude.
One such contract manufacturer identified by Searle is Synthetech, which has been involved in several Searle development projects. These projects involved Synthetech's production of key starting materials and/or process intermediates. In some projects, Searle provided the technology to prepare chemical compounds required for the development process. In other cases, Synthetech used its own proprietary technology. In all cases, both companies worked together closely from initial synthesis of small quantities of materials through successive scale-ups to larger quantities.
"A high degree of trust has developed between Searle and Synthetech as the result of the successful collaborations between the two companies," says Buchman. "Synthetech has added value to Searle's research and development programs by consistently supplying high-quality products on-time and within budget. The business relationship has been mutually beneficial. Today, Synthetech is one of Searle's most valued and preferred suppliers," Buchman adds.
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