Analytical techniques as instruments for biopharmaceutical characterization

Gjorgieva Ackova, Darinka and Smilkov, Katarina and Janevik-Ivanovska, Emilija and Stafilov, Trajče and Arsova-Sarafinovska, Zorica and Makreski, Petre (2017) Analytical techniques as instruments for biopharmaceutical characterization. In: 17th CEEPUS Symposium and Summer School on Bioanalysis, 2-8 July 2017, Ohrid, R. Macedonia.

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Drugs with biological origin or biopharmaceuticals are products where the active substance is composed of or derived from living organisms and often represent the crossing of the boundaries of medical science and different fields of research (Walsh, 2003). They can be composed of carbohydrates, nucleic acids, proteins, or complex combinations of these substances, or may be composed from live cells or tissues. Unlike chemically synthesized small molecules that have a well-defined structure and are thoroughly characterized, the pharmaceutical products with biological origin are complex in structure and therefore their full characterization is great achievement.
Analytical methodology that is currently in use enables a comprehensive characterization and identification of biopharmaceuticals (determination of molecular weight and particle size, physico-chemical properties, identity, purity and homogeneity, biological activity, immunochemical properties, purity/impurities (if present), present isoforms and structures of higher order, and stability of the product) and covers implementation of variety of physico-chemical, immunological and biological methods (ICH, Specifications Q6B; Tuma, 2005; Wakankar et al., 2011; Gjorgieva Ackova et al., 2015).
Here, we used a multiple set of analytical techniques (HPLC, SDS-PAGE, ICP-MS, MALDI-TOF, TLC, UV/VIS, FTIR and Raman spectroscopy) for extensive characterization of immunocomplexes of antibody rituximab intended for use as radiopharmaceutical.

Item Type: Conference or Workshop Item (Poster)
Subjects: Natural sciences > Biological sciences
Natural sciences > Chemical sciences
Medical and Health Sciences > Health biotechnology
Medical and Health Sciences > Health sciences
Medical and Health Sciences > Other medical sciences
Divisions: Faculty of Medical Science
Depositing User: Katarina Smilkov
Date Deposited: 11 Dec 2017 12:50
Last Modified: 11 Dec 2017 12:50

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