Technology Transfer 101
Barry Rosenblatt, Ph.D., President, SME Biotech Consulting; is a subject matter expert in the chemistry and manufacturing controls (CMC) of biotherapeutics with a proven 30+ year track record in biotechnology and the pharmaceutical industry. Developed, transferred and validated purification processes and assays for multiple new molecular entities through all stages of drug development, including licensure. Currently serving as a consultant to the industry as President/sole proprietor of SME Biotech Consulting. The proven presenter who has served as an instructor, presenter, as well as Chairperson for conferences and courses. Previously served as associate director of Process Development for Centocor/JNJ (18 years) and 8 years as head of Analytics, Process Evaluation, Contract Manufacturing, and Sterile Services at Charles River Laboratories, Malvern PA... Academic credentials include a Ph.D. in Cell Biology/Immunology from the Albert Einstein College of Medicine, Bronx, NY.
This session explores the elements required for a successful technology transfer between various sites. It is intended for anyone who may be involved in the transfer of information between groups or sites. This includes both internal transfers as well as transfers to a third party. Upon completion of this session, the attendee will have a greater understanding of the process and what is required to ensure a higher probability of success.
Transfer of knowledge between groups is a key part of any drug development. Many projects end up with setbacks due to an incomplete or incorrect transfer of information due to lack of understanding on the part of the team(s) performing the transfer as well as the teams receiving the information.
Areas Covered
- Elements of Technology Transfer
- Equipment and instrumentation requirements
o Qualification - Change control
- Tools of the trade
o Documentation
- Protocols
- Development reports
- Summary reports
o Assessment - Types of Technology Transfer
o Example of different transfers
o Potential pitfalls - Structure of technology transfer team(s)
o Role of core teams vs subteams
o The construct of “shadow teams” - Project management
- Special cases
Course Level - This presentation is at a beginning to intermediate level
Who Should Attend
- Process development scientists
- Project managers
- Manufacturing scientists/managers
- Process Engineers
Why Should You Attend
Any transfer of knowledge between departments or sites is subject to potential failures on multiple fronts, due to
- Lack of information
- Improper planning
- Misjudgment of the capabilities of the receiving site
- Lack of engineering match
- Insufficient vetting of the transfer
The purpose of this presentation is to examine the elements of technology transfer and why it can or cannot succeed
-
$200.00
-
