Purification and formulation of biotechnological drug products

A.Y. 2020/2021
8
Max ECTS
64
Overall hours
SSD
CHIM/08 CHIM/09
Language
Italian
Learning objectives
The course is intended to cover principles and general requirements for the development of biotechnological medicinal products from the isolation and the purification of the active substances to the formulation of pharmaceutical dose forms. References are made to the quality assays, compendial and not, to characterize active substances and dosage forms. Regulatory aspects relevant to production and marketing are also addressed.
Expected learning outcomes
At the end of the course, the student will acquire principles required to design biotechnological medicinal products, based on the specific properties of the active substance and the therapeutic requirements. Starting from the main chemical-physical characteristics of the molecules, the student will be able to propose the most suitable methods to produce, isolate and purify the related drug substances under sterile conditions according to the Good Manufacturing Practices.
Thanks to the knowledge and understanding acquired, the student will be able to individuate the criticisms and to define an appropriate control strategy in the attempt to satisfy the Regulatory Agencies' requirements.
Course syllabus and organization

Unique edition

Responsible
Lesson period
Second semester
Downstream processing of biopharmaceuticals
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 0
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 0
Lessons: 32 hours
Formulation of biotechnological medicinal products and Regulatory Aspects
CHIM/08 - PHARMACEUTICAL CHEMISTRY - University credits: 0
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 0
Lessons: 32 hours
Professor: Minghetti Paola