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Chapter 2 basic lab techniques
- 1. BASIC LAB TECHNIQUES MODULE 1 CHAPTERS 2 Life cycle of A biotech company
- 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
- 6. WHAT TYPE OF LABS ARE IN A BIOTECH COMPANIES?
- 7. TYPES OF LABS RESEARCH & DEVELOPMENT QA/QC ENVIRONMENTAL MONITORING
Notas del editor
- 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