DRUG INDUSTRY AND PHARMACEUTICAL BIOTECHNOLOGIES

Course Topics

Part I

Pharmaceutical Biotechnologies

1. Introduction

Section I

Fermentative Biotechnologies

1. General notions of fermentative biotechnologies
2. Pharmaceutical fermentative biotechnologies

Section II

Genetic Biotechnologies

1. The flow of genetic information2. Recombinant DNA Technology3. Recombinant Human Insulin4. Interferon

5. Other drugs obtained by recombinant DNA technology

Part II

The management of the industrial drug production

Section I

1. Development of a drug (design, production and implementation of the pilot phase)
2. Industrial production of the drug. Pharmaceutical companies
3. Elements that generate quality product; Equipment qualification and validation of manufacturing processes

Section II

1. Rules of good practice in manufacturing and evaluating the pharmaceutical products
2. Classification and evaluation of variations in composition and process for the industrial pharmaceutical products
3. Design and analysis of pharmaceutical quality

Part III

Industrial Pharmaceutical Technology

1. Materials used for the conditioning drugs
2. Materials used for the construction of the machinery used in drug industry
3. Corrosion and corrosion protection methods

Practical Work Topics

Part I

Pharmaceutical Biotechnologies

1. Introduction
2. Genetic Biotechnologies. The study of nucleic acids
3. Expression and purification of proteins of pharmaceutical interest

Part II

Industrial Plants

1. The reactor
2. Mechanical Operations
3. Hydrodynamic Operations
4. Thermal Operations
5. Other Operations
   

Part III

Technological processes for industrial production of pharmaceuticals (Tolbutamide, sodium saccharin, Hydrochlorothiazide, Lidocaine, salicylic, metamizole sodium, Paracetamol, Oxichinolul, Clorquinaldolul, nicotinic acid and derivatives, Trimethoprim, methyl p-hydroxybenzoate, Iodiseptul, ascorbic acid etc.)

Part IV

1. Technological flows for obtaining pharmaceutical forms of drugs in enterprises.
2. Pilot station

Selective Bibliography

Alberts B., Johnson Al., Lewis J., Raff M., Roberts K., Walter P., Molecular biology of cell, Garland Science, Taylor & Francis Group, New York, 2002;

Andries A.A., Lupuleasa D., Oteleanu D., Zuchi Gh., Hancu L., Sultana Nita, Cazacincu R.,  Procese tehnologice de obtinere industriala a unor substanALe farmaceutice, Ed. Universitara Carol Davila, Bucuresti, 2006;

Constantinescu D., Vaireanu D. I., Maior Ioana, Stiinta materialelor, Ed. Matrix Rom, Bucuresti, 2004;

Aiache J.-M., Beyssac E., Cardot J.-M., Hoffart V., Renoux R., Inistiation a la connaissance du medicament, Elsevier Masson SAS, 2008;

Couper J.R., Penney W.R., Fair J.R., Walas S.M., Chemical process equipment, Elsevier, 2005;

Jurcoane Stefana, Biotehnologii, Ed. Tehnica, Bucuresti, 2000;

Kimball N., Glossary of biotechnology terms, CRC Press, 2002;

Klefenz H., Industrial pharmaceutical biotechnology, Wiley, 2002;

Leucuta E. Sorin, Tehnologie farmaceutica industriala, Ed. Dacia, Cluj-Napoca, 2001;

Muntean Marcela, Ghizdavet AL Z., Proiectarea fabricilor, Ed. Matrix Rom, BucureAYti, 2003;

Mitrea Niculina, Lupuleasa D., AndrieAY A.A., Enoiu Milica, Biotehnologii utilizate in prepararea medicamentelor, Ed. Medicala, BucureAYti, 2002;

Popovici Iuliana, Lupuleasa D., Tehnologie farmaceutica vol. I-III, Ed. Polirom, IaAYi, 1997;

Scriban R. Biotechnologie Ed. Technique & Documentation, Lavoisier, Paris, 1993;

Walsh G., Biopharmaceuticals, Wiley, 2004;

***Pharmaceutical Manufacturing Encyclopedia, Third Edition, William Andrew Publishing, Norwich, NY, USA, 2007;

*** Farmacopeea Romana, Editia a X-a, Ed. Medicala, Bucuresti, 1993;

*** European Pharmacopoeia , Ed.8.0, Directorate for the Quality of Medicine & Health Care (EDQM), Council of Europe, Strasbourg, France, 2013;

*** The United States Pharmacopeia, The United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852, 36, 2013.