Downstream

Less is More in mRNA Therapeutics: Developing Big Ideas in Small Scale

This webcast features: Linda Mathiasson, Strategic Customer Lead, Cytiva. Messenger RNA technology has changed the way therapies are developed. The overall potential of mRNA is clear, with mRNA therapeutics being developed in many research areas. The speed and potential cost gains of mRNA technology make it an interesting technology for personalized medicine. However, much of the current equipment used in manufacturing is repurposed from the biotech industry and is designed for much larger scales than needed for mRNA. In this…

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…

Downstream Process Development for the Purification of Biosimilar Insulin from Escherichia Coli

This webcast features: Sharon Bola, Global Product Manager, Process Chromatography, Bio-Rad Laboratories. With the increasing global demand for insulin product, there is a need to develop a more efficient and economical process for the production of recombinant insulin therapeutics. In this webcast, we will present an efficient downstream processing workflow for recombinant human insulin production using Escherichia Coli as the host system. Data will be presented for sample preparation and purification results of proinsulin and insulin. Size exclusion was identified…

Robust and Scalable MAb Capture Facilitated by a Novel Convecdiff Membrane Structure

Alternative stationary phases are being developed to solve the shortcomings of bead chromatography processes, namely high diffusional resistance leading to long processing cycles (4–6 h). Targeted lifetimes of 75–150 bind and elute cycles, taking sometimes years to achieve and requiring cleaning and respective validation, storage, and column unpacking and repacking, elevate costs and introduce increasingly unacceptable bioburden risks. Chromatographic membranes, due to intrinsically high mass transfer rates, overcome these limitations, enabling residence times of seconds and full lifetime utilization (75–150…

Leveraging Post-Translational Modifications and Bio-Functional Assays for Characterization of Charged Variants

This webcast features: Shawn Fitzgibbons, Senior Manager & Jacob Kraus, Manager, Biologics Analytical, Catalent. The heterogeneity of a biologic product has implications for the safety and efficacy of the final biotherapeutic or biosimilar therapy. It is important to characterize the charged variant profiles of biologics, since many important post-translational modifications (PTMs) impart or alter the charge (isoelectric point or pI) of the molecule, potentially impacting stability, pharmacokinetics, and pharmacodynamics. Examples of charged variants include lysine variants and deamidation products, both…

Enabling mRNA-Based Therapeutics Development Through Efficient and Scalable mRNA Purification Methods

This webcast features: Jenny England, PhD, R&D Manager, Innovation & Applications Group, Thermo Fisher Scientific. As a direct result of the COVID-19 pandemic, mRNA-based therapeutics development has made major progress. The potential of using mRNA as a therapy seems to be endless and an increasing number of indications is filling up the clinical pipeline rapidly. As the development of these therapies continues to rise, the industry is looking into efficient and scalable manufacturing techniques. To support the commercial production of…

Purification of DNA Oligonucleotides Using Anion Exchange Chromatography

This webcast features: William H. Rushton, Process Chromatography Support Scientist, Bio-Rad Laboratories. DNA oligonucleotides obtained by solid-phase synthesis contain incomplete or erroneous sequences that require removal for the advancement of these molecules as therapeutics. These key impurities in crude samples are length-based and are best removed by anion exchange chromatography. In this webcast, data will be presented using Nuvia HP-Q Resin, a high-performance strong anion exchanger, used for the purification of two oligonucleotides (20-mer and 21-mer) having a phosphodiester backbone.…

Next Generation PATfixTM Software

This webcast features: Blaž Goričar, Process Analytics Development Manager, BIA Separations, now a Sartorius company. Process development and production of gene therapy products brings together people with different skills and specializations, hence PATfixTM software is built to address the needs and solve challenges of each. An integral part of the PATfixTM value proposition, the PATfixTM software strips away the complexity of chromatography at the day-to-day operational level, while retaining it for higher level tasks. Analytical chromatography is rapidly gaining supremacy…

Ask the Expert: 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,…