Example 1: Antibiotic Production Isolation or collection of cultures Development of pilot plant Screening of cultures to detect those production methods with antimicrobial activity Submission of licence for clinical Development of methods for submerged-culture production Testing of purified antibiotic Development of methods for Development of plant scale isolation and purification of production methods antibiotic Obtaining a product licence for Determination of antibiotic clinical use properties(physical: adsorption Other miscellaneous considerations and absorption, chemical: reactions, Development of methods to control solubility in solvents, stability to production of antibiotic acids, alkalis, heat etc. Development of new applications Evaluation of antibiotic Development of marketing and Pharmacological tests distribution system Antimicrobial activity Financing of business Comparison with existing antibioticExample 1: Antibiotic Production • Isolation or collection of cultures • Screening of cultures to detect those with antimicrobial activity • Development of methods for submerged-culture production • Development of methods for isolation and purification of antibiotic • Determination of antibiotic properties (physical: adsorption and absorption, chemical: reactions, solubility in solvents, stability to acids, alkalis, heat etc.) • Evaluation of antibiotic – Pharmacological tests – Antimicrobial activity – Comparison with existing antibiotic • Development of pilot plant production methods • Submission of licence for clinical trials • Testing of purified antibiotic • Development of plant scale production methods • Obtaining a product licence for clinical use • Other miscellaneous considerations: – Development of methods to control production of antibiotic – Development of new applications – Development of marketing and distribution system – Financing of business