BASIC LAB TECHNIQUES

MODULE 1CHAPTERS 2

Life cycle ofA biotech company

The business of biotechnologyProduct 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 affairschapter 2

LIFE CYCLE OF A COMPANY

•START UP•MANUFACTURE•COMPANY GROWTH

• MARKETING & SALES• BUSINESS DEVELOPMENT• ACCOUNTING• HUMAN RESOURCES• PACKAGING• METROLOGY –MAINTAINING INSTRUMENTS• MANAGE CLINICAL RESEARCH

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

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

WHAT TYPE OF LABS

ARE IN A BIOTECH

COMPANIES?

TYPES OF LABS

RESEARCH

& DEVELOPMENT

QA/QC

ENVIRONMENTAL

MONITORING