Page 15 - REC :: M.Tech. BioTech Curriculum and Syllabus - R2019

 To provide knowledge on the lyophilizedproducts

UNIT-I DRUG DEVELOPMENT 9
Drug development, Pharmacokinetics – Absorrption, Distribution, Metabolism and Excretion. Pharmacodynamics
UNIT-II RECOMBINANT BIOPHARMACEUTICALS &DOSAGEFORMS 9
Medically important recombinant proteins – Factor VIII – Human insulin – Human somatotropin. Formulation
of tablet –coated tablets, gelatin capsules, suspension and emulsion.
UNIT-III BIOSIMILARS 9
Biosimilar medicine-INN nomenclature system – key trends in biosimilar product development – Production of
biosimilar products –Non clinical and clinical study – Regulation and approval process
UNIT-IV LYOPHILIZATION AND PRODUCT ANALYSIS 9
Lyophilization equipment – Protein based contaminants – Detection of protein based impurities –
Immunological approach – Endotoxin and other pyrogenic contaminants.
UNIT-V ADJUVANT TECHNOLOGY AND CONTROLLED RELEASE MEDICATION 9
Safe and potent adjuvant for human use – Development – Mineral adjuvant – Mucosal and non-parenteral –
Adjuvants in non-infectious disease vaccine – T cell adjuvants – Clinical evaluation of adjuvants. Controlled
release medication –oral osmotic pump and osmotic pressure activated drug delivery systems..
Total Contact Hours : 45

Course Outcomes:
 Understand the basic principles of preclinical trials and clinicaltrials
 Obtain knowledge in concept of genetic engineering in the production of recombinantproducts.
 Understand the approval process involved in Biosimilarproduction
 Learn various techniques to produce lyophilizedproducts.
 Obtain knowledge on the formulation of advanced drugedeliverysystem

Text Book(s):
Walsh, G., “Pharmaceutical Biotechnology-Concepts and Application”, John Wiley and Sons Publishers,
1
2007.
Crommelin, D.J.A., Sindelar, R.D. and Meibohm, B., “Pharmaceutical Biotechnology: Fundamentals and
2
rd
application”, 3 Edition, Informa Health care,2007.

Reference Books(s) / Web links:
Carter, S.J., “Cooper and Gunn's Dispensing for Pharmaceutical Students”, CBS Publishers &
1
Distributors,2008.
2 Schijns, V.E.J.C. and Ohagan, D.T., “Immunopotentiators in Modern Vaccines”, Elsevier academic press, 2006
3 Gad, S.C., “Handbook of Pharmaceutical Biotechnology” John Wiley & sons,2007.
4 Reminton”pharmacypractice”

BY19204 IMMUNOTECHNOLOGY Category L T P C
3 0 0 3

Objectives:
 To impart knowledge about the development of immune cells and theirfunction
 To provide knowledge on immune defense mechanism, through which pathogeneliminationoccurs
 To explain the principle of various types of immunologicaltechniques
 To provide basic knowledge on various types of vaccines and theirdevelopment
 To enable the student to lay a strong foundation on immunological orientedresearch.

UNIT-I IMMUNE SYSTEM ANDITSRESPONSE 9
Cells of the immune system and their development – Primary and secondary lymphoid organs – Immunity and
their types - Humoral immune response – Cell mediated immune responses – Hypersensitivity and their types