L4-1046 — Annual report 2009
1.
The dilemma of modern integrated approaches to quality assurance and control

Modern biopharmaceutical industry searchs for novel approachs and technologies in the R&D within the umbrella of "Quality by Design" principle. Within the lecture and in the expert's paper author, who is an expert for biopharmaceuticals at the Agency for Medicines (EMEA), novel technologies deal with the discovery of specific peptidic molecules, including a phage display technology, is demonstrated. The main part of the presentation deals with novel approaches of qualty assurance and control from gene construction to final drg product.

B.04 Guest lecture

COBISS.SI-ID: 3727736
2.
The analysis of pharmacologically active compounds in biomolecules in real samples

The analysis of biological molecules, among them peptidic biopharmaceuticals in real samples (urine, blod, liquor, food) represents the scientifc challenge. Methods and technologies were developed and presented in the book, edited by Rade injac and Borut Å trukelj, and published by Transworld Research network Publishing House.

C.03 Guest-associated editor

COBISS.SI-ID: 2686833