Education Sessions
Importance of Science and Engineering
Link in
Technology Transfer
E-MG2
| 4 November 15.00-17.00 | Track: Manufacturing |
ISPE CEUs: 0.2
Technology transfer is one of the most challenging aspects of production today and will continue to be challenging tomorrow. Whether it is development scale-up, transfer of an existing process to a new facility, or expanding the network to a contract manufacturer, success requires the foundation of:
- Comprehensive product (science),
- Process (engineering) knowledge,
- Capable partners (manufacturing), and,
- Attention to detail during execution.
Case studies on both well-managed and difficult projects, along with lessons learned illustrating how to effectively transfer technology will be presented. The ISPE Good Practice Guide: Technology Transfer is also referenced. Soft skills such as team formation and communication are not forgotten as key contributors to successful transfers.
Take Back to Your Job
- Establish an effective cross-functional team composed of development, engineering, and manufacturing to ensure a successful technology transfer
- Formulate the requirements between product attributes, process parameters, and equipment capabilities necessary to produce a successful transfer
- Avoid pitfalls by learning from previous case studies.
Who Should Attend
Individuals involved in all aspects of technology transfer, including, but not limited to development, engineering, manufacturing, quality, regulatory affairs and validation professionals in the biotechnology, pharmaceutical, and device industries.
Session Leader
- Avril Balfrey, Senior Engineer, Amgen Inc
Session Speakers
- Neslihan DelaCruz, Principal Engineer, Amgen Inc
- YC Lee, Senior Director, PharmEng Innovations
- Stephen Perry, President, Kymanox
