2020/2021

2021/2022

DM270

CHIM/09 (APPLIED TECHNOLOGICAL PHARMACEUTICS)

DEPARTMENT OF MOLECULAR MEDICINE

MEDICAL AND PHARMACEUTICAL TECHNOLOGIES

Farmaceutico:Biotecnologie farmaceutiche per la ricerca e sviluppo

2°

1st semester (04/10/2021 - 21/01/2022)

9

76 lesson hours

Italian

WRITTEN TEST

CONTI BICE (titolare) - 6 ECTS
CONTI BICE (titolare) - 3 ECTS

=

To provide the knowledge required from the technological point of view for the development of
biotech products; to give proper skills for the production of biotech products and to provide the
knowledge needed from the regulatory point of view for the market authorization of biotech products.

Drug Delivery Systems and Targeting of Biotech Drugs program
Controlled drug delivery systems (cDDS): classification of the DDS as function of the control (temporal, spatial and hybrid) , of release mechanism: diffusion controlled (reservoir and monolithic system), chemically controlled (biodegradable system) and water penetration controlled (swellable and osmotically controlled).
Targeted drug delivery systems (tDDS): targeting to organ (microspheres, microcapsules and microaggregates), to tissue (liposomes, nanospheres and nanocapsules) and to cells (polymeric vectors, monoclonal antibodies and biological macromolecules).
Aim of the course will be to deepen the knowledge concerning controlled and targeting DDSs intended for parenteral administration which is the gold standard administration route for biotech drugs. Discussion of case studies.
Manufacturing and Industrial Systems program
Biotech industry structure and organization, Good Manufactory Practices (GPC), integrated research and development process, batch records, production units, sale-up and validation.
Pharmaceutical production plants, personnel, security . Manufactory, quality control and quality assurance, common technical document.
Technical centralized services for the Pharmaceutical/Biotech industry: steam, water, heat ventilation and air conditioning system, vacuum and, gases.
Unitary processes: theory, technologies, methods and equipment of freeze-drying, filtration and sterilization (clean rooms and production in sterile conditions) processes. Practical laboratory will be organized on these topics.
Regulatory affairs and patent system for Biotech Products program
Applicable regulations. Medicines and the quality control, quality assurance: regulatory agencies (AIFA; EMEA and FDA)
International Conference and Harmonization (ICH).
Market Authorization: Centralized authorization procedure, National authorization procedure, Decentralized procedure and Mutual-recognition procedure. Regulation 726/2004, Directive 2001/83/EC and Directive 2004/27/CE and Legislative decree 219/2006.
Good Manufacturing Practice (GMP) the attention will be focused on biotech Products.
Common Technical Document (CTD).
EMA and FDA guidelines for Biotech products.
Patent and critical aspects related to the biotech products patents.

The course is based on lectures provided by the instructor integrated with practical experience (preparation and characterization of controlled and targeted DDS).

Biotecnologie Farmaceutiche, Crommelin D.J., Sindelar R.D., Zanichelli Editore.
Compendio di Biotecnologie Farmaceutiche, Calabrò M.L., EdiSES Editore.
Fabris L., Rigamonti A. LA FABBRICAZIONE INDUSTRIALE DEI MEDICINALI. Società Editrice Esculapio, Bologna, 2008.
Lachman L., Lieberman H., Kanig J. THE THEORY AND PRACTICE OF INDUSTRIAL PHARMACY, Ed. Lea & Febiger, USA.
F.U.I.XII ed. Eur. Ph. Edizione corrente

Examination on the whole course contents, in oral form.

Examination on the whole course contents, in oral form.