Downstream

Using Monolith-Based Chromatography to Monitor In Vitro Transcription Reactions

In vitro transcription (IVT) is a critical step in messenger RNA (mRNA) production. In a March 2022 webinar, Rok Sekirnik (head of process development for mRNA and plasmid DNA (pDNA) applications at BIA Separations, part of Sartorius) explained that optimizing concentrations of reagents used during IVT helps to maximize the amount of mRNA that is produced. Drug developers have great need for analytical methods that can measure IVT in real time. Sekirnik showed how CIMac PrimaS monolith chromatography columns enable…

Bridging Anti-CHO HCP Antibodies From Two Third Generation Cygnus CHO HCP ELISA Kits by AAE-MS™

This webcast features: Eric Bishop, Vice President, Research & Development, Cygnus Technologies. A well-developed, broadly reactive, and qualified HCP ELISA remains a gold standard method effectively used during the purification process to ensure removal of HCP and to demonstrate process consistency and final drug substance purity. Regulatory guidelines require that sponsors use orthogonal methods for demonstrating antibody coverage to individual HCPs and provide a comprehensive assay qualification package to ensure the HCP ELISA is fit for purpose. In this presentation,…

Transform Your AAV Analytics With Mass Photometry

This webcast features: Gareth Rogers, Product Manager, Refeyn, and Kirsty McManus, Senior Scientist, Characterization Team, Pharmaron Biologics. Mass photometry is a novel, easy-to-use bioanalytical technology that measures the empty-full AAV capsid ratio in minutes using minimal sample amounts and without the need for sample preparation. Circumventing the requirement of large capital expense and skilled operators, it can be employed in different AAV workflows. In this webinar, we present a novel mass photometry instrument called SamuxMP, which is dedicated to the…

Leveraging NISTmAb Prior Knowledge to Demonstrate Analytical Competency

The NISTmAb IgG1κ monoclonal antibody reference material, from the National Institute of Standards and Technology, is intended for use in evaluating the performance of analytical methods that determine physicochemical attributes of biologics. As a case study, Almac Sciences have assessed NISTmAb and its prior knowledge to demonstrate competency in chromatography and capillary electrophoresis methods. Key Takeaways: Analytical challenges during establishment of NISTmAb methods. Comparability assessment of NISTmAb data to demonstrate analytical competency. Transition of capillary electrophoresis methods from 32Karat software…

Streamline cGMP Viral Vector Analytical Challenges With Robust and Sensitive Impurity, Fragment Sizing, and Oncogene Quantitation Assays

This webcast features: Jonas Buege, Product Manager, Thermo Fisher Scientific. The therapeutic potential of viral vector-based gene therapies is tremendous, but with some recently adverse outcomes in clinical trials, the safety of these drugs has come into question. Both regulatory agencies and manufacturers are working hard to define appropriate critical quality attributes and identify process-related impurities crucial to ensuring patient safety. These requirements increase the demand of analytical development teams working on viral vectors, over traditional biopharmaceuticals, to utilize novel…

Minimize Risk With Rapid At-Line Concentration Measurement in Downstream Bioprocessing Applications

This webcast features: Paul Mania, Bioanalytics Applications Specialist, Repligen. Traditional UV/Vis spectroscopy uses fixed pathlengths to measure different analytes, such as nucleic acids, proteins, and cells from biological samples. These samples are often limited in volume or highly concentrated, which presents various challenges. The CTech™ SoloVPE® System uses a patented variable pathlength technology (VPT) to accurately measure the targeted concentration of various analytes. The system measures concentrations without being dependent on sample volume or sample concentration, removing any dilution requirements,…

Increasing Productivity of IVT Reaction Using At-Line Monitoring by HPLC Chromatography

This webcast features: Rok Sekirnik, PhD, Head of Process Development mRNA/pDNA, BIA Separations, now a Sartorius company. In Vitro Transcription (IVT) reactions are normally performed as batch processes. Considering their catalytic basis, it is possible to extend reaction times and yields by continuous addition of consumed reagents to the reaction mixture. However, fed-batch strategies reported to date have only managed to achieve a 40 – 100% increase in the production of mRNA. One of the main limitations of development has…

Viral Clearance: A WuXi Advanced Therapies Perspective

This webcast features: Kathleen Kenney, Associate Director, Viral Clearance, WuXi Advanced Therapies, R. Christopher Manzari, Manager, Viral Clearance – DSP/Virus Production, WuXi Advanced Therapies. Join us for a discussion on the risk-based approach in the development of Viral Validation studies, a key testing requirement for regulatory submissions of viral vector-based therapeutics, at WuXi Advanced Therapies. In this webinar, members of the Viral Clearance Management team will cover the basics of viral clearance, study development and the general timeline. Collaboration between…

Addressing Purification Challenges for Complex Therapeutics with Custom Chromatography Resins

This webcast features: Laurens Sierkstra, Business Segment Leader, Bioproduction Group, Thermo Fisher Scientific. Ongoing progress in biotherapeutics development has initiated an increasing range of complex molecules entering the drug development pipeline such as novel vaccines and therapeutic proteins. This often rises challenges in the manufacturing process of these newer modalities, with downstream operations as a focus point as this part of the production process frequently represents a bottleneck. Addressing downstream challenges requires novel purification strategies for commercial manufacturing which may…

The Way Forward in Therapeutic Antibody Purification

This webcast features: Dr. Anna Le Bris, Senior Application Specialist and Trainer, Thermo Fisher The development of therapeutic antibodies has made an enormous progression in the last decades. Antibodies have become the predominant class of biological drugs and are used to treat a variety of diseases such as cancer. Recently, neutralizing antibodies to halt infectious diseases are entering the clinical pipeline, including against Sars-Cov2. Affinity purification platforms such as Protein A or L are well established in the manufacturing process…