February 1, 2012
By:Fiona M Greer BSc (Hons) MSc PhD, SGS Life Science Services
Various countries have established pathways to allow “copies” of an off-patent biotherapeutic product on the market. This paper addresses the regulatory hurdles and characterization challenges of developing a Biosimilar product.
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January 31, 2012
By:Srinivasa Rao, Yuanxue Hou, Hongmin Zhang, Yury Agroskin, Chris Pohl, Thermo Fisher Scientific
These new Thermo Scientific MAbPac SCX small particle phase columns were developed for high resolution separations wand orthogonal selectivity for MAb charge variant characterization. Separations using these columns on the bio-inert Thermo Scientific Dionex UltiMate 3000 Titanium LC System revealed high-resolution, fast analysis of MAb variants.
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January 31, 2012
By:Rick Johnson, PhD, Bioproduction Group(Bio-G)
QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process. This whitepaper looks at how biomanufacturing organizations can achieve continuous quality verification. We focus on simple, practical examples of how top-tier biomanufacturers have implemented QbD.
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November 29, 2011
By:George Limpert, Celsis Analytical Services
Celsis has added a Dionex ICS-3000 ion chromatographic system. This system determines inorganic anions, cations and organic acids, as well as uses amperometric detection for accurate analysis of traditionally difficult pharmaceuticals.
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November 29, 2011
By:Dr. Richard Easton, SGS Life Science Services
Glycosylation is a diverse form of post-translational modification. Mass spectrometry based techniques provide a powerful tool to characterize and to assess and modify the developmental pathway of a therapeutic glycoprotein.
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November 29, 2011
By:Peter Soelkner, Vetter Pharma International GmbH
With fewer blockbuster drugs in the pipeline, companies are on the lookout for an enduring solution to meet market challenges. To maintain or expand market shares, pharmaceutical companies must devise new strategies to remain competitive.
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October 25, 2011
By:Dr. Andrew J. Reason, SGS Life Science Services
A number of new monoclonal antibody products and monoclonal antibody biosimilars are in development, all require extensive characterization to obtain the necessary approvals for clinical trials and eventually marketing approval.
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