Technology Transfer and Integration for Pharmaceutical and Biotech Industry 2013

Technology transfer and integration for pharmaceutical operations are critical, time-consuming processes. Intra-company project and product transfers within and between research and development and commercial manufacturing sites require great attention. It is imperative to avoid suboptimal transfers as the business and regulatory consequences are severe. As the pharmaceutical business has evolved, there has been a greater use of contract research organizations, contract manufacturing organizations, in-licensing, mergers, and acquisitions. Timely, cost-effective technology transfer processes are therefore increasing and successful transfers and integrations are to maintain business continuity. This course is designed to cover a range of transfer and integration challenges ranging from a single project to a large portfolio. Throughout the short course, examples and case studies highlighting real life examples will be used. Initially, the basic building blocks of a transfer process will be reviewed. A recently developed "equation for success" will also be employed to demonstrate the key components in transfer processes. Each building block will be reviewed in appropriate detail. Useful tools to aid in transfers will be covered. The course will then review transfers of drug products (including sterile products) and active pharmaceutical ingredients. Typical challenges faced and potential pitfalls will be shared. A short interactive exercise for audience participation is included to cover salient aspects from the earlier presentations.
Upon completion of the short course participants should be able to 1) list the critical requirements of technology transfer process for drug products, API, and analytical methods; 2) describe the regulatory requirements for technology transfers; 3) identify resources for technology transfer process; 4) discuss critical technical requirements for successful technology transfers; and 5) identify major challenges associated with technology transfer between companies.