Costum Manufacturing  
PROCESS Woldwide-PharmaTEC 06-2004

Increasing the hit rate
Pilot fermentation line improves access to natural substances for use in R&D


What options are open to you when you have to invest a lot of time and effort to solve complex problems? The answer is you look for partners to work with. Dolder, based in Basel/Switzerland, is a partner that specializes in biotechnology production of natural substances.

Natural substances play a key role for pharmaceutical and biotechnology companies which are engaged in research to develop new, innovative active ingredients and lead structures. These substances are particularly important in the field of antimicrobial and immunosuppressive agents and cancer therapy. The number of naturally occurring substances is extremely large. Combining parts of different natural substances and synthetic fragments can significantly increase this number even further, and it is a very promising approach to the development of new lead structures for medical and agro-chemical applications, because the biological activity of the derivatives often surpasses that of the original substances. However, the natural substance which is needed is often difficult to obtain or is only available on the market in small quantities at very high prices. Small and medium-size pharmaceutical and biotechnology companies often do not have the technology or capacity necessary for biotechnology production of natural substances, which can be a highly complex process. Outsourcing partners have the technical experience and expertise to provide the support that these companies need.

Taking advantage of synergy effects
This scenario led to the creation of a strategic partnership between Dolder and Novartis Pharma. Companies engaged in pharmaceutical and biotechnology research can make use of Dolder’s outsourcing services to manufacture new or familiar natural substances using existing production methods or to develop a suitable process for making a particular natural substance. The plant has 24 fermenters with reactor volumes up to 3000 liters as well as special equipment for product purification. The company has special know-how in the fermentation and cultivation of difficult microorganisms like mixobacteria, and it is able to produce them in large volumes. The Novartis bio pilot plant benefits from many years of industrial experience in the entire process development chain, and it offers a range of services extending from contract manufacturing to development of a manufacturing process. Dolder is responsible for project management, marketing and sales of natural substances. The company is an international sourcing and distribution organization which handles pharmaceutical active ingredients, advanced intermediates and polymers. Besides focusing on the product portfolio, the company continues to expand its registration, approval and supplier qualification activities. In addition to non-GMP production of natural substances such as staurosporin, hygromycin A and geldanamycin, which are used in applications like drug discovery and the development of substance libraries, the company conducts research into microorganisms for specific natural substances and provides scientific support for the services it provides.

Setting up the right conditions to promote optimal growth of microorganisms is a delicate operation involving a lot of variables. You need trained personnel to keep the process under con-trol.

 Usefull Links 
Product portfolio of Dolder (URL: http://www.dolder.com)
Fast link to Novartis (URL: http://www.novartis.com)




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