CARBOGEN AMCIS is part of a multi-site, transcontinental organization, offering our customers the opportunity to obtain a comprehensive range of chemical and manufacturing solutions from one single supplier. This extends from rapid Active Pharmaceutical Ingredients (APIs) supply for preclinical use to large-scale manufacture of intermediates and APIs. An efficient technology transfer process is the key for a successful transfer either from the customer to CARBOGEN AMCIS or among the CARBOGEN AMCIS sites.

With the operation of the CARBOGEN AMCIS high potency plant in India, expertise in the technology transfer process will be of considerable advantage to CARBOGEN AMCIS customers.

Technology Transfer Process
Complex, multi-step processes under both Good Manufacturing Practice (GMP) and non-GMP have been successfully transferred. For transfer outside of Switzerland, a specialist team follows an established three-stage procedure:
1.    Initiation: the scope and goals are agreed upon by all parties – preparation of technology transfer master plan, definition of responsibilities, as well as preparation and transfer of technical information package;
2.    Piloting: the process is trialed in the lab and in small production runs and extensively reviewed – compliance with regulatory and quality standards; and
3.    Sign-off: the mutually agreed process is accepted by all parties – production against established batch instructions.
A crucial element in successfully transferring technology processes across linguistic and cultural barriers is frequent communication involving our experienced personnel.
Clear definitions of the responsibilities of the technology transfer team members during the transfer process minimize the time and effort needed for this critical step in the successful scale-up of intermediates or APIs.

Case Study 1: Cost Advantages and Continuous Local Management
The first three steps from a registered process, previously run in Switzerland on 1,600 L scale, were successfully transferred to operations in India within a timeframe of five months. The intermediate of an API which goes generic in a few years required us to provide larger quantities of intermediates at lower costs. The process is now being performed on a scale up to 4,000 L with the intermediate being sent to Switzerland for further conversion to the final API. This approach offers the maximum flexibility in handling the cost and quantity demands of the product in development and commercialization life cycles.
The customer benefits from cost advantage and continuous local project management.

Case Study 2: Cost Savings and Project Scale
For a US customer, a three-stage process to manufacture an intermediate starting material of a launched product was transferred within six months from the CARBOGEN AMCIS Ltd site in Manchester, where it was successfully produced in a 600 kg campaign (several batches up to 200 kg), to India. The process was scaled up there in campaigns of 1,500 kg. This commercial product requires a very high purity and the team was able to successfully duplicate the process. This is another critical step toward the projected demand of approximately eight metric tons per year.

Case Study 3: Cost and Feasibility Aspects
For a Japanese customer, a multi-stage production process for a non-GMP intermediate was performed at CARBOGEN AMCIS’ Manchester site and subsequently transferred to India within six months. A chemist from Manchester supported the transfer on-site. There, the production now runs in 300 kg batches toward a five metric ton campaign. A further capacity expansion to run a 28 metric ton campaign is planned for the end of 2008 in India. The transfer was driven by the scale of production.