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2014 Pittcon Tosoh Bioscience Seminars
Please reserve a seat and a complimentary gift for me in Seminar Room 05 in the Exhibit Hall at Pittcon 2014 for the seminars, dates, and times I have selected below:
Monday, March 3, 2014 - 1:00 pm
Monoclonal Antibody Purification with High Capacity Protein A Resins: What is the Benefit?
Chris Manzari, Process Marketing Manager, Tosoh Bioscience
The past 15 years have seen advances in biotechnology that have allowed the increased use of monoclonal antibodies (mAbs) as the main constituent of therapeutic drugs. With the increased commercial utilization of these molecules, it is imperative that chromatographers have access to the tools necessary to develop purification processes that maximize productivity while keeping operating costs to a minimum. This presentation will discuss the use of High Capacity Protein A resins as a productivity enhancer in the monoclonal antibody capture step, and how the use of these resins can influence purification steps further downstream.
Monday, March 3, 2014 - 1:30pm
Scaling-Up from Bench to Process Scale With Pre-Packed Chromatography Columns
Steve Tingley, Vice President, BioProcessing Sales & Marketing, Repligen
Many of the world’s leading biopharmaceutical companies have adopted single use and disposable technologies for faster product changeover, favorable economics, and improved safety. While single-use and disposable technologies are prevalent in many areas within upstream and downstream processing, up until now there has not been a broadly applicable solution for chromatography steps. In this presentation, the scalability, durability, and cost savings associated with pre-packed disposable chromatography columns will be discussed.
Monday, March 3, 2014 - 2:00 pm
Aggregates in Monoclonal Antibody Manufacturing Processes – A Brief Review of Separation by Analytical and Large Scale Chromatography
Atis Chakrabarti, Ph.D., Manager, Technical Service, Tosoh Bioscience
Monoclonal antibodies have proven to be a highly successful class of therapeutic products. Pharmaceutical antibodies are manufactured through a complex process which involves both large-scale manufacturing including process development as well as analytical development. Clinically approved therapeutic proteins need to be adequately stable. An unstable protein may cause immunogenic reactions or may simply lose its therapeutic value. Both can potentially be harmful for a patient.
Aggregation is one of the many factors which can compromise the quality of the drug product. The extent of aggregation at all different stages of the manufacturing process, starting from fermentation until the final step of storage may vary but need to be analyzed. Tosoh Bioscience offers a comprehensive line of process media and high and low pressure analytical columns to meet every kind of purification need in this regard. This presentation will primarily discuss the tools from the different chromatographic modes used to analyze and separate aggregates during monoclonal antibody industrial production and analytical development.
Monday, March 3, 2014 - 2:30 pm
Troubleshooting, Column Lifetime Tips and Tricks
Justin Steve, Technical Service Specialist, Tosoh Bioscience
HPLC systems and analytical chromatography columns are costly. Method development is time consuming and can also be costly. It is important to employ an HPLC system that is optimized with regards to extra-column band broadening to take full advantage of the high column efficiency that can be obtained on analytical columns. This presentation is about common but often ignored method development and troubleshooting issues - in general, a discussion of column lifetime issues encountered in different modes of analytical chromatography.
Monday, March 3, 2014 - 3:00 pm
The Multiple Utilities of Gel Permeation Chromatography for Polymer Analysis
Amandaa Brewer, Ph.D., GPC Sales Support Lead, Tosoh Bioscience
Since its inception the principle use of gel permeation chromatography (GPC) has been to determine the molar mass averages and distributions of natural and synthetic polymers. In general these properties have been characterized through the application of calibration curves via a single-detector instrumental set-ups e.g. GPC-refractive index (RI). Over the years the complexity of polymers has increased, making the ability to obtain accurate and precise distributions of both their physical and chemical properties more difficult. These challenges have piloted a new era of polymer analysis: multi-detector GPC.
Here, we will discuss the multiple uses of single- and multi-detector GPC in the polymer industry, namely the coupling of GPC to various combinations of RI, UV-Vis, multi-angle light scattering (MALS), and differential viscometry (VISC) to detect differences from batch-to-batch or lot-to-lot of a given polymer, to monitor reaction processes, to determine variations in molar mass averages obtained through different synthesis routes, and to distinguish between polymers with the same chemical composition but different end-use properties. Additionally, we will provide an overview of using the addition of a MALS detector to a single-detector GPC system in a research and development type environment for the determination of not only the absolute, calibrant-independent, molar mass and molar mass distributions but also polymeric size information.
Monday, March 3, 2014 - 3:30 pm
High Temperature Gel Permeation Chromatography using Refractive Index Detection
Ilir Koliqi, Laboratory Products Manager, Tosoh Bioscience
The main utility of single-detector high temperature gel permeation chromatography (GPC) is to extract quantitative information from the elution curves obtained via a concentration sensitive detector with accuracy and precision. Traditionally, molar mass averages and distributions of polymers are determined using peak position calibration involving polystyrene standards of known molar mass and chemistry analyzed by GPC coupled to a differential refractive index detector (RI). The repeatability and reproducibility of the molar mass averages obtained by GPC/RI are directly dependent on the baseline stability of the RI detector.
Here, we introduce the newest GPC instrument from Tosoh Bioscience for polymer characterization, the EcoSEC® High Temperature GPC System. The repeatability, reproducibility, and baseline stability of a dual flow RI detector in the EcoSEC High Temperature GPC System for the determination of molar mass averages via peak position calibration at temperatures up to 220 ° will be discussed. The dual flow RI detector design is shown to compensate for any changes in the refractive index of the solvent over time by continuously flowing pure solvent through the reference side of the flow cell, thus significantly increasing baseline stability of the RI detector and the repeatability and reproducibility of the molar mass averages. Additionally, the durability and stability of Tosoh Bioscience’s new high temperature GPC columns will be showcased.
Monday, March 3, 2014 - 4:00 pm
High Resolution Heterogeneity Analysis of Therapeutic Antibodies by HPLC
Atis Chakrabarti, Ph.D., Manager, Technical Service, Tosoh Bioscience
Monoclonal antibodies(mAbs) are now widely used for therapeutic treatment, with an increasing number of mAb candidates entering into the market. During production, storage and transportation, therapeutic mAbs may undergo structural modifications such as aggregation, fragmentation, truncation of C-terminal lysine, deamidation of asparagine, isomerization of asparate, oxidation of methionine, etc… Generation of the variants can affect the efficacy, safety and stability of the mAb, so the analysis and characterization of variants is essential. In this presentation, we will demonstrate how variants can be separated by employing three modes of HPLC; Size exclusion chromatography, Ion exchange chromatography and Hydrophobic interaction chromatography.
Tuesday, March 4, 2014 - 1:00 pm
Monoclonal Antibody Purification with High Capacity Protein A Resins: What is the Benefit?
Chris Manzari, Process Marketing Manager, Tosoh Bioscience
Tuesday, March 4, 2014 - 1:30pm
Scaling-Up from Bench to Process Scale With Pre-Packed Chromatography Columns
Steve Tingley, Vice President, BioProcessing Sales & Marketing, Repligen
Tuesday, March 4, 2014 - 2:00 pm
Aggregates in Monoclonal Antibody Manufacturing Processes – A Brief Review of Separation by Analytical and Large Scale Chromatography
Atis Chakrabarti, Ph.D., Manager, Technical Service, Tosoh Bioscience
Tuesday, March 4, 2014 - 2:30 pm
Troubleshooting, Column Lifetime Tips and Tricks
Justin Steve, Technical Service Specialist, Tosoh Bioscience
Tuesday, March 4, 2014 - 3:00 pm
The Multiple Utilities of Gel Permeation Chromatography for Polymer Analysis
Amandaa Brewer, Ph.D., GPC Sales Support Lead, Tosoh Bioscience
Tuesday, March 4, 2014 - 3:30 pm
High Temperature Gel Permeation Chromatography using Refractive Index Detection
Ilir Koliqi, Laboratory Products Manager, Tosoh Bioscience
Tuesday, March 4, 2014 - 4:00 pm
High Resolution Heterogeneity Analysis of Therapeutic Antibodies by HPLC
Atis Chakrabarti, Ph.D., Manager, Technical Service, Tosoh Bioscience
Wednesday, March 5, 2014 - 1:00 pm
Monoclonal Antibody Purification with High Capacity Protein A Resins: What is the Benefit?
Chris Manzari, Process Marketing Manager, Tosoh Bioscience
Wednesday, March 5, 2014 - 1:30pm
Scaling-Up from Bench to Process Scale With Pre-Packed Chromatography Columns
Steve Tingley, Vice President, BioProcessing Sales & Marketing, Repligen
Wednesday, March 5, 2014 - 2:00 pm
Aggregates in Monoclonal Antibody Manufacturing Processes – A Brief Review of Separation by Analytical and Large Scale Chromatography
Atis Chakrabarti, Ph.D., Manager, Technical Service, Tosoh Bioscience
Wednesday, March 5, 2014 - 2:30 pm
Troubleshooting, Column Lifetime Tips and Tricks
Justin Steve, Technical Service Specialist, Tosoh Bioscience
Wednesday, March 5, 2014 - 3:00 pm
The Multiple Utilities of Gel Permeation Chromatography for Polymer Analysis
Amandaa Brewer, Ph.D., GPC Sales Support Lead, Tosoh Bioscience
Wednesday, March 5, 2014 - 3:30 pm
High Temperature Gel Permeation Chromatography using Refractive Index Detection
Ilir Koliqi, Laboratory Products Manager, Tosoh Bioscience
Wednesday, March 5, 2014 - 4:00 pm
High Resolution Heterogeneity Analysis of Therapeutic Antibodies by HPLC
Atis Chakrabarti, Ph.D., Manager, Technical Service, Tosoh Bioscience
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