Manufacturing of Biotechnological Drug Products
A.Y. 2018/2019
Learning objectives
This course aims to provide students with knowledge on the following topics:
- industrial processes used in the production of medicinal products of biotechnological origin;
- organization of manufacturing in a pharmaceutical company with specific reference to the production of finished products containing substances of biotechnological origin;
- cell therapy and advanced therapy medicinal products;
- legislative framework defining the requirements necessary for marketing application of medicinal products according to EC regulations.
- industrial processes used in the production of medicinal products of biotechnological origin;
- organization of manufacturing in a pharmaceutical company with specific reference to the production of finished products containing substances of biotechnological origin;
- cell therapy and advanced therapy medicinal products;
- legislative framework defining the requirements necessary for marketing application of medicinal products according to EC regulations.
Expected learning outcomes
Undefined
Lesson period: First semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
Course syllabus and organization
Single session
Responsible
Lesson period
First semester
Technology processes and pharmaceutical regulatory affairs
Course syllabus
· Utilities in pharmaceutical facilities: water and air.
· Sterile drug and biological products: consideration on production, implants and GMP. Requirements of critical areas for the production by aseptic processing.
· General aspects of lyophilization
· Lyophilization of protein
· Nanotechnologies and "complex" generics,
· Workplace safety
· Common Technical Document (CTD): e-CTD and variations
· EMA guidelines for the production of biotech medicinal products
· Structure and organization of biotech plant
· Quality assurance of Good Manufacturing Practice (GMP)
· Quality risk management (ICH Q9),
· Pharmacovigilance
· Cellular therapy and advanced therapy
· Access to pharmaceutical market
· Introduction to Quality by Design (ICH Q8),
· Introduction to Design of Experiments (DoE)
· Patents for biotechnological produces
· Technology transfer
· Viral validation
· ADC (Antibody Drug Conjugates)
· Sterile drug and biological products: consideration on production, implants and GMP. Requirements of critical areas for the production by aseptic processing.
· General aspects of lyophilization
· Lyophilization of protein
· Nanotechnologies and "complex" generics,
· Workplace safety
· Common Technical Document (CTD): e-CTD and variations
· EMA guidelines for the production of biotech medicinal products
· Structure and organization of biotech plant
· Quality assurance of Good Manufacturing Practice (GMP)
· Quality risk management (ICH Q9),
· Pharmacovigilance
· Cellular therapy and advanced therapy
· Access to pharmaceutical market
· Introduction to Quality by Design (ICH Q8),
· Introduction to Design of Experiments (DoE)
· Patents for biotechnological produces
· Technology transfer
· Viral validation
· ADC (Antibody Drug Conjugates)
Pharmaceutical production organization
Course syllabus
· Utilities in pharmaceutical facilities: water and air.
· Sterile drug and biological products: consideration on production, implants and GMP. Requirements of critical areas for the production by aseptic processing.
· General aspects of lyophilization
· Lyophilization of protein
· Nanotechnologies and "complex" generics,
· Workplace safety
· Common Technical Document (CTD): e-CTD and variations
· EMA guidelines for the production of biotech medicinal products
· Structure and organization of biotech plant
· Quality assurance of Good Manufacturing Practice (GMP)
· Quality risk management (ICH Q9),
· Pharmacovigilance
· Cellular therapy and advanced therapy
· Access to pharmaceutical market
· Introduction to Quality by Design (ICH Q8),
· Introduction to Design of Experiments (DoE)
· Patents for biotechnological produces
· Technology transfer
· Viral validation
· ADC (Antibody Drug Conjugates)
· Sterile drug and biological products: consideration on production, implants and GMP. Requirements of critical areas for the production by aseptic processing.
· General aspects of lyophilization
· Lyophilization of protein
· Nanotechnologies and "complex" generics,
· Workplace safety
· Common Technical Document (CTD): e-CTD and variations
· EMA guidelines for the production of biotech medicinal products
· Structure and organization of biotech plant
· Quality assurance of Good Manufacturing Practice (GMP)
· Quality risk management (ICH Q9),
· Pharmacovigilance
· Cellular therapy and advanced therapy
· Access to pharmaceutical market
· Introduction to Quality by Design (ICH Q8),
· Introduction to Design of Experiments (DoE)
· Patents for biotechnological produces
· Technology transfer
· Viral validation
· ADC (Antibody Drug Conjugates)
Pharmaceutical production organization
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Lessons: 24 hours
Professor:
Adami Marco Oreste Luca
Technology processes and pharmaceutical regulatory affairs
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor:
Adami Marco Oreste Luca
Professor(s)
Reception:
to be arranged by email