On-Demand Webinars: Pharma & Biopharma

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Farmaceutika i biotehnologija

Biopharma

The Multi-Attribute Method (MAM): Advancing Biopharmaceutical Discovery, Development, and Manufacturing
The multi-attribute method (MAM) for structural confirmation of protein therapeutics involves a targeted search of peptide mapping data using advanced, GMP-compliant-ready software, for pre-determined components that are indicative of numerous critical quality attributes (CQA).
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Understanding Biotherapeutic Product Quality Attributes through a Multi-Attribute Method (MAM) Lab-of-the-Future
In the development of biotherapeutics, a thorough understanding of a molecule’s product quality attributes (PQAs), and their effect on structure-function relationships and long-term stability, is key for ensuring the safety/efficacy of the product. At present, numerous routine chromatographic and electrophoretic assays are used to characterize and monitor individual PQAs for batch release, stability time-points and process/formulation development support. However, execution of multiple routine methods is time/resource intensive and often provides an indirect measure of biologically-relevant PQAs. Learn about an MS-based multi-attribute method (MAM) “Lab-of-the-Future,” that provides concurrent detection, identification, quantitation and quality control (monitoring) of PQAs.
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Assessing Critical Quality Attributes and Structural Conformation of Biotherapeutics by HDX-MS
Full structural characterization is critical in biopharmaceutical development where the subtle but critical local conformational changes of a therapeutic protein can impact safety and efficacy. Hydrogen deuterium exchange (HDX) mass spectrometry (MS) is a powerful tool for studying the dynamics of higher order structure of protein-based therapeutics. The rate of hydrogen-to-deuterium exchange within the amide hydrogen on the backbone of biotherapeutics provides solvent accessibility information and thus protein structure and conformation can be inferred.
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Characterizing Biopharmaceuticals and Bioprocesses Using Native Thermo Scientific Orbitrap LC-MS View webinar
New Enzymatic Workflows for Analysis of O-Glycosylated Biopharmaceuticals
O-glycosylation is a difficult post-translational modification to analyze. The heterogeneity of O-glycosylation can make MS analysis difficult. Currently, there is a growing interest in this type of glycosylation and a need for new tools. The OglyZOR enzyme is an O-glycosidase able to remove O-glycans from proteins under native conditions. Paired with PNGase F, a total deglycosylation of complex biopharmaceuticals can be achieved by middle-level MS.
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Top-Down Characterization of a Site-specific Antibody-drug Conjugate
Peptide mapping is the gold standard for in-depth characterization of biotherapeutics; however, sample preparation, LC runtime and data analysis can be labour intensive and time consuming. Top or middle-down mass spectrometry experiments show promise as an alternate technique for primary order structure confirmation. However, historically top or middle-down characterisation has been limited by bottlenecks in data processing, and lower sequence coverage.
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On-demand Webinar: Taking Charged Variant Analysis of Therapeutic Proteins to the Next Level
Take charge of your protein analysis and learn about updated methodology for protein characterization. Attend this on-demand webinar to learn about advances in therapeutic protein charge variant characterization, and how to see your therapeutic proteins in higher resolution or with additional on-line identification.
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Easily navigate biotherapeutic modifications View webinar  
Peptide separations with pinpoint precision
How to achieve ultimate retention time reproducibility & high resolution separation of peptides. Learn how to increase confidence in biopharma peptide mapping. In this webinar series, four new technologies will be demonstrated that dramatically improve upon established mapping workflows.
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Take the smart route to protein digestion
How to increase reproducibility whilst reducing preparation time. Learn how to increase confidence in biopharma peptide mapping. In this webinar series, four new technologies will be demonstrated that dramatically improve upon established mapping workflows.
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MAb Characterization Webinar View webinar
High Resolution Accurate Mass (HRAM): The capability of next generation mass spectrometers for quantitative bioanalysis
HRAM, next generation mass spectrometry for quantitative bioanalysis. High-throughput methods for quantitation of biotherapeutics by both intact protein and proteolytic peptides.
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FTIR Spectroscopy for Structure Elucidation of Proteins
During the past decade, FTIR spectroscopy has gained significant prominence as a tool for structure elucidation of proteins – from formulations in R&D to Quality Control in Manufacturing. FTIR has many advantages including measuring: 1) at dosage concentrations – both low and high; 2) in different states such as liquid and solids; and 3) with variety of excipients.  The measurements are straightforward and the equipment is very affordable.  Regulatory agencies often list FTIR as one of the techniques recommended for proof-of-folding and structure comparability. This webinar will describe the process of determining protein secondary structure.
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Pharma

Polar and Ionic Components in Pharmaceutical and Biopharmaceutical Industry | On-Demand Webinar
This webinar recording gives an overview on ion chromatography (IC) solutions for pharma and biopharma analysis. Hear examples on counter ion and degradation products analysis, and learn about bio-ion chromatography for anions, organic acids, sulfur containing compounds, carbohydrates, amino acids, proteins and peptides.
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The Role of Ion Chromatography in the USP Monograph Modernization Initiative
In this educational webinar, Dr. Ravi Ravichandran discusses the role of ion chromatography in the USP’s efforts to modernize its existing monographs.
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Understanding the Challenges of E&L Contaminant Analysis for Pharmaceutical Quality Assurance
Discuss the basics of Extractables and Leachables with respect to Pharmaceutical QA
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Two-Dimensional HPLC in Pharmaceutical Analysis View webinar
Driving Confidence in Your Process: Tools for FTIR QA/QC
Whether your data will be used in process control, in court, or in assuring upstream and downstream quality, you need hardware and software tools designed to give your stakeholders – and you – confidence. The Thermo Scientific line of  FTIR spectrometers provides everything you need, from ASTM compliance to digital signatures. This webinar will examine some of these tools and show practical processes for data-critical labs.
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Ensuring Integrity of Drug Formulation from Development to QC
Substantial testing is required to assure that chemical and structural integrity are preserved throughout the drug development process to maintain its functionality. Among the techniques used to study changes in chemical integrity are infrared and Raman spectroscopy. This webcast will discuss where efficiencies can be made in data collection, regulatory compliance, instrument qualification, method validation, and data integrity all along the development pipeline up to final quality control (QC) testing. Learn how to quickly identify changes in polymorphic structure, monitor API to excipient distribution, and troubleshoot out-of-specification (OOS) product lots, while preserving data integrity needed for audits. Key Learning Objectives Where along the drug development path can FTIR, NIR and Raman techniques be used and what knowledge is gained How to minimize the number of laborious steps in analytical method validation, verification, and transfer to QC and manufacturing What to look for in a hardware-software platform to not only assure drug formulation integrity but also data integrity.  
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Pharmaceutical Analysis with FTIR, Near-IR, Mid-IR and Raman in a Compact Platform
Pharmaceutical laboratories face strong regulatory requirements and market pressures at every step along the product development pipeline. This webinar presents data that shows how the analytical needs of these laboratories – for speed, reliability and flexibility – can be improved with the new Nicolet iS50 FTIR spectrometer. Switching between multiple techniques can be achieved in seconds to customize workflows or perform confirmatory testing on a single sample. Learn how this multi-functional platform enables: Basic drug research and structural elucidation Formulation development and validation Quality control processes for incoming and outgoing materials Packaging testing  
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Infrared and UV-Vis Spectroscopy in Pharmaceutical QC – Part 1: Regulatory Considerations
Ensuring compliance with regulatory requirements for pharmaceutical and medical device manufacturers is essential for delivering safe and effective products. Poor quality data can lead to a multitude of consequences, including out-of-specification results, delays in product release or even product recalls. The first webinar in this two-part series guides you through the challenges of effectively navigating the regulated environment. We address the need to quickly commission the spectroscopy equipment and ensure proper day-to-day use through system qualification, SOP development and system suitability testing.  
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Infrared and UV-Vis Spectroscopy in Pharmaceutical QC – Part 2: Ensuring Product Quality
During the pharmaceutical manufacturing process, quality control is required at every step to ensure safe and effective products. Poor product quality can lead to a multitude of consequences, including delays in product release or even product recalls. The second webinar in this two-part series presents how UV-Visible and Infrared spectroscopy play a critical role as essential quality control tools in the manufacturing process. We address how these tools help ensure product quality while bringing simplicity to your work.  
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Ensuring Integrity of Drug Formulation from Development to QC
Substantial testing is required to assure that chemical and structural integrity are preserved throughout the drug development process to maintain its functionality. Among the techniques used to study changes in chemical integrity are infrared and Raman spectroscopy. This webcast will discuss where efficiencies can be made in data collection, regulatory compliance, instrument qualification, method validation, and data integrity all along the development pipeline up to final quality control (QC) testing. Learn how to quickly identify changes in polymorphic structure, monitor API to excipient distribution, and troubleshoot out-of-specification (OOS) product lots, while preserving data integrity needed for audits. Key Learning Objectives Where along the drug development path can FTIR, NIR and Raman techniques be used and what knowledge is gained How to minimize the number of laborious steps in analytical method validation, verification, and transfer to QC and manufacturing What to look for in a hardware-software platform to not only assure drug formulation integrity but also data integrity  
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Raw Material Identification with NIR Spectroscopy
Both pharmaceutical and dietary supplement manufactures are required to perform 100% ingredient identity testing under current Good Manufacturing Practice (cGMP) regulations. Supplied materials such as API, bulking agents, lubricants and solvents must be qualified at the point of entry into the factory to ensure finished product integrity. FT-NIR spectroscopy is well-suited for this type of analysis because it is, fast, non-destructive, does not require sample preparation, and can be performed by non-technical operators with limited training. It also allows chemicals with almost any functional group to be identified within seconds replacing costly and time consuming primary wet chemistry techniques such as HPLC. You will learn how to: Achieve rapid, multi-component analysis without chemical or disposable costs Replace wet chemistry techniques that are time consuming and labor intensive Determine the quality of incoming raw materials at intake Monitor and control your process, maximize production, and profitability See advantages that Near Infrared has for ID testing  
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Visualizing, characterizing, and analyzing pharmaceutical constituents with raman imaging
45 minutes
Presenter: Dr. Robert Heintz, Raman Applications Specialist, Thermo Fisher Scientific Pharmaceutical formations are typically complex mixtures that need to be carefully verified and understood. Raman spectroscopy is a proven method for identifying and verifying the presence of a variety of different components and providing detailed information on molecular structure and chemical environments.  Raman imaging adds a spatial dimension to the analysis and extends the power of Raman spectroscopy across the sample. Some of the applications of Raman imaging relevant to pharmaceutical evaluations include: Revealing  spatial distribution of components –  homogeneity and content uniformity Assessing particle size including relative percentages of components Differentiating and displaying  chemically similar components such as polymorphs Quickly surveying larger areas and conducting detailed studies of smaller areas  
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Visualizing, characterizing, and analyzing pharmaceutical constituents with Raman imaging
45 minutes
Presenter: Dr. Robert Heintz, Raman Applications Specialist, Thermo Fisher Scientific Pharmaceutical formations are typically complex mixtures that need to be carefully verified and understood. Raman spectroscopy is a proven method for identifying and verifying the presence of a variety of different components and providing detailed information on molecular structure and chemical environments.  Raman imaging adds a spatial dimension to the analysis and extends the power of Raman spectroscopy across the sample.
Some of the applications of Raman imaging relevant to pharmaceutical evaluations include: Revealing  spatial distribution of components –  homogeneity and content uniformity Assessing particle size including relative percentages of components Differentiating and displaying  chemically similar components such as polymorphs Quickly surveying larger areas and conducting detailed studies of smaller areas    
View webinar ›