Advanced Analytical Methodology in Biopharmaceutical Quality Control

Biopharmaceuticals are an emerging unique class of drugs due to their extreme structural complexity. The manufacturing process in the Biopharmaceuticals industry varies with each type of molecule (proteins/peptides/DNA fragments) and is far more elaborate and stringent due to the use of living organisms and complex substrates. Recombinant protein therapeutics/Fusion Engineered protein purity and altered structural characteristics leading to potential immunogenicity have often been of concern when establishing quality and safety. Another important issue dealing with quality control is that recombinant proteins are often unstable, aggregate and/or do not reach the fully native conformation compatible with proper biological activity.
Therefore, the structure of these therapeutic recombinant proteins/biopolymers, such as antibodies, is critically important for their efficacy and safety, and the ability to characterize it at various levels (from sequence to conformation) is essential not only at the quality control stage, but also throughout the discovery/design and development stages.

Several analytical methods offer a variety of approaches to study structure and function of complex recombinant protein drugs for characterizing the covalent structure of protein therapeutics, including sequence and post-translational modifications but also to assess the secondary and tertiary structure, essential to guarantee activity.
During Bioforum Course, fast analytical methodologies will be introduced for biopharmaceuticals quality control aiming at structure characterization (CD, NMR, MS), method selectivity (LC, CE), impurities characterization and determination (LC-DAD-MS, CE-MS), stability studies (CD, MS, NMRLC-DAD-MS, CE-MS), protein folding and misfolding.

Recently, MS-based methods have also begun enjoying a dramatic growth in popularity as a means to provide information on higher order structure and dynamics of Biopharmaceuticals. In particular, hydrogen/deuterium exchange MS and charge state distribution analysis of protein ions in electrospray ionization (ESI) MS offer a convenient way to assess the integrity of protein conformation. Native ESI MS also allows the interactions of protein drugs with their therapeutic targets and other physiological partners to be monitored using simple model systems.

Moreover, regulatory compliance in manufacturing and commercialization of biopharmaceuticals (Good Manufacturing Practice GMP) involves quality control, quality assurance, and batch documentation. Many factors such as host cell development, cell bank establishment, cell culture, protein production, purification, analysis, formulation, storage, and handling are critical for ensuring the purity, activity, and safety of the finished product.

The Bioforum course deals with all these analytical issues involved in biopharmaceuticals quality control.

If you already participated at Bioforum course previous edition(s), do not miss this opportunity to enlarge your knowledge on the most advanced bio-analytical methodologies in biopharmaceuticals quality control by attending SSPA 2013!