2. The business of biotechnology
Product Life Cycle
Research early studies. If successful
then:
development: establish product and
production process the scale up. Some
time between development and
production there is
(Pilot plant – a medium size)
Production
QC/QA
Regulatory affairs
chapter 2
3. LIFE CYCLE OF A COMPANY
•START UP
•MANUFACTURE
•COMPANY GROWTH
• MARKETING & SALES
• BUSINESS DEVELOPMENT
• ACCOUNTING
• HUMAN RESOURCES
• PACKAGING
• METROLOGY –MAINTAINING INSTRUMENTS
• MANAGE CLINICAL RESEARCH
4. INTELLECTUAL PROPERTY
NEEDS TO BE PROTECTED (INFRINGEMENT)
PATENT LASTS ABOUT 20 YEARS
LICENCE
PATENTING LIVING ORGANISMS – RIGHT OR
WRONG?
TRADE SECRETS GIVES ADVANTAGE TO THE
OWNER
EMPLOYEE , SUPPLIERS SIGN NONDISCLOSURE
AND NON COMPETE AGREEMENT
5. TYPES OF LABS
RESEARCH LAB - STUDY NATURE IN A
CONTROLLED ENVIRONMENT
TESTING LAB – ANALYSIS PERFORMED
TEACHING LABORATORY – WHERE STUDENT
STUDY NATURE
WHAT IS THE PRODUCT OF A LAB?-
KNOWLEDGE
7. TYPES OF LABS
RESEARCH
& DEVELOPMENT
QA/QC
ENVIRONMENTAL
MONITORING
Hinweis der Redaktion
R&D: Most biotech companies have research in academia or in their R&D departmentDocumentation required for each step in R&DProduction: Bioreactors, small vessels, plant cultures, purification processesQA/QC: QC – monitoring the process, lab testingQA – ensure the final quality of the program. Check paperwork, documentation, investigate problemsRegulatory affairs – if product is regulated by the government. To complies with government rules and regulations.Employees work with regulatory agencies
PATENT: INNOVATION, INVENTION NOT OBVIOUS, INVENTION IS USEFUL, THE OWNER IS THE FIRST TO INVENT THE ITEM