Master of Industrial Drug Development, MIND
Hold

Process Development and Production of Active Pharmaceutical Ingredients (API)

Uddannelsen giver indsigt i udviklingen af et lægemiddel fra forskning og udvikling til klinisk afprøvning, produktion og optimering.

Uddannelsen henvender sig til forskere, ledere og andre professionelle, som beskæftiger sig med udvikling af nye lægemidler. 

Den typiske deltager har en baggrund inden for områder som teknik, farmaci, kemi, biokemi eller sundhedsvidenskab.

Uddannelsen foregår på engelsk.

Holdinformation

Startdato: 30/05/2023
Slutdato:
02/06/2023
Optagelsesfrist:
03/04/2023
Afholdelsesform:
Dagundervisning
Hjemmeside:
Kontaktinformation: Københavns Universitet (Kbh.Univ.)
Undervisningen foregår: Blegdamsvej 3B
2200 København N
Pris:
12 900.00
Tilmeldingsblanket:
Skolens tilmeldingsblanket
Skolens tilmeldingsside:

Beskrivelse

The course is intended for drug development professionals with contact to chemical process development.
Content
All relevant subjects related to the chemical process development of biologically active compounds used as pharmaceuticals will be discussed. The course will begin with the discovery synthesis and end with the full-scale production process.

Basic conventions terms and definitions will be discussed. Focus will be placed on scale-up, process optimization, yield considerations, purification, validation, registration, and regulatory approval for new processes.

Various strategies to achieve a safe, more economical, and defensible process will be covered. Other topics to be covered include: Design of Experiments, route scouting, telescoping, 2nd generation processes, process monitoring, selection of appropriate in-process controls, process analytical technology (PAT), thermogravimetric analysis, reaction calorimetry, and differential scanning calorimetry.

Examples of process developments will be given both for small molecular compounds and biopharmaceuticals.

Further subjects are quality assurance, GLP and GMP considerations, Quality-by-Design (QbD), environmental considerations, life cycle management, emission limits and monitoring, resource consumption and CO2-emission, safety, hazard and operability, risk assessment and handling excessive reaction conditions.

Uddannelsessteder