Journal of Proteomics & Bioinformatics
Open Access

Analytical characterization for novel biological entities and biosimilars

5^th International Conference on Proteomics & Bioinformatics

September 01-03, 2015 Valencia, Spain

Alastair Waugh

3P Biopharmaceuticals, Spain

Scientific Tracks Abstracts: J Proteomics Bioinform

Abstract :

Biopharmaceutical products are hugely successful but expensive, and making copies of them as â�?�?Biosimilarsâ�? represents the new direction to control costs and increase availability. They are very attractive for existing and new players within the industry. Biopharmaceuticals, as proteins, are fundamentally complex and require extensive analytical characterization to understand their structure and hence assure their clinical function and safety. The activity of Analytical Characterization forms a core part of the regulator submission package, and is subcategorized into various studies. The definition of the Critical Quality Attributes (CQA) and hence the establishment of the Quality Target Product Profile (qTPP) are required for all products, and for Biosimilars there is an additional requirement to prove the Analytical Comparability to the innovator product. Using a monoclonal antibody as a case study, the analytical methods required to determine the primary structure, higher order structure, heterogeneity and post translational modification, glycosylation and in-vitro activity will be explored. Within this context, the power in use of orthogonal approaches to look at the same analytical attribute but with different methods and the factors required to establish comparability will be considered.

Biography :

Alastair Waugh completed his PhD in Protein Biochemistry from the University of London and continued with Post-doctoral studies at UCL. Subsequently, he has gained 10 years experience within the biopharmaceutical industry, where he has focused on analytical development of protein drugs as novel entities or as biosimilars. He has wide experience for the analytical techniques and the analytical studies required to bring products to market. Currently he is the Head of Analytical Development at 3P Biopharmaceuticals, which is a contract development and manufacturing organization for biopharmaceuticals.

Email: acw.waugh@gmail.com