Analysis of Biopharmaceuticals: A Deeper Dive into Bioseparations

Ensuring the safety and efficacy of biotherapeutics from research to development, and then from manufacturing to quality control is essential to bring a product to market. Large molecules pose unique challenges for biotherapeutic analyses in that they often require running a panel of tests to ensure product efficacy and safety.

Industry efforts have evolved towards comprehensive analytical workflows that enable researchers to monitor critical quality attributes (CQAs) of highly complex and diverse biotherapeutic molecules.

Part 2: A Deeper Dive into Bioseparations

In the second session of this series we will discuss the range of bioseparation approaches used for characterization of CQAs in more detail. This includes solutions available for native (Size Exclusion, Ion Exchange, HIC) and reduced state (RP, HILIC) bioseparations for analysis of mAbs and other biotherapeutics.

 

Donna Potts
Biopharma Market Specialist EMEA IDO
Agilent Technologies

Donna is a Biopharma Market Specialist for Agilent Technologies; over the last decade she has been responsible for business development for Agilent analytical solutions in the Biopharma market space. Donna has worked extensively with biomolecules during her career, with a strong emphasis on Life Science and Biopharma applications using LC-MS.

After completing Postdoctoral Research at Boston University School of Medicine, she worked as an application specialist before becoming a Market Specialist in 2013. Donna holds a PhD in Analytical Chemistry from The University of Manchester, UK, where her studies focused on protein quantitation using mass spectrometry.

 

Cecilia Mazza
Product Specialist, EMEA IDO – Chemistries & Suppliers
Agilent Technologies

With more than 20 years of professional experience, Cecilia is presently the Product Specialist for columns and supplies at Agilent. Supporting distributors and laboratory users in the analysis and purification of small and large molecules, for a wide range of LC and GC applications as well as sample preparation.

Cecilia holds a Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute in US.

 

Register and watch on demand >

 

Analysis of Biopharmaceuticals: Introduction to Workflows

Ensuring the safety and efficacy of biotherapeutics from research to development, and then from manufacturing to quality control is essential to bring a product to market. Large molecules pose unique challenges for biotherapeutic analyses in that they often require running a panel of tests to ensure product efficacy and safety.

Industry efforts have evolved towards comprehensive analytical workflows that enable researchers to monitor critical quality attributes (CQAs) of highly complex and diverse biotherapeutic molecules.

Part 1: Introduction to Workflows

This presentation will provide an insight into the basics of the biopharma industry and introduce how analytical tools can be utilised as part of comprehensive workflows for characterisation of CQAs.

 

Donna Potts
Biopharma Market Specialist EMEA IDO
Agilent Technologies

Donna is a Biopharma Market Specialist for Agilent Technologies; over the last decade she has been responsible for business development for Agilent analytical solutions in the Biopharma market space. Donna has worked extensively with biomolecules during her career, with a strong emphasis on Life Science and Biopharma applications using LC-MS.

After completing Postdoctoral Research at Boston University School of Medicine, she worked as an application specialist before becoming a Market Specialist in 2013. Donna holds a PhD in Analytical Chemistry from The University of Manchester, UK, where her studies focused on protein quantitation using mass spectrometry.

 

Cecilia Mazza
Product Specialist, EMEA IDO – Chemistries & Suppliers
Agilent Technologies

With more than 20 years of professional experience, Cecilia is presently the Product Specialist for columns and supplies at Agilent. Supporting distributors and laboratory users in the analysis and purification of small and large molecules, for a wide range of LC and GC applications as well as sample preparation.

Cecilia holds a Ph.D. in Chemical Engineering from Rensselaer Polytechnic Institute in US.

 

Register and watch on demand >

 

InfinityLab OnLine HPLC Solution

In modern production of small molecule pharmaceuticals, biopharmaceuticals, and, in fact, ALL production batches, the reaction has to be closely monitored and potentially even controlled by, for instance, online reaction monitoring analytics. Therefore, connecting a UHPLC instrument by a sampling device to the reaction vessel can be helpful. The 1260 Infinity II Prime Online LC offers a combined UHPLC and integrated reactor sampling interface for automated reaction sample analysis with the Agilent 1260 Infinity II Online Sample Manager. This device enables the drawing of samples from a reactor and dilution/quenching prior to an injection.

This presentation will include a look at the hardware and software used for the Agilent OnLine LC system.  We will log into a live system to view the setup possibilities and review data acquired on the system.

 

Bob Giuffre
Application Engineer
Agilent Technologies, Inc.

 

Bob Giuffre has been working with HP/Agilent for almost thirty years as an Application Scientist for the HPLC product line. During that time Bob has worked on applications ranging from small molecule pharmaceutics to large molecule polymers, to monoclonal antibodies. Currently, Bob is working in the area of ultra-high pressure two-dimensional liquid chromatography as a means to increase peak capacity for complex formulations. Bob has authored a chapter on the use of Diode-Array Detection in Pharmaceuticals. He is currently writing a chapter on Troubleshooting Peptide and Proteins Analysis using LC-MS.

 

Register and watch on demand >