Ask the Experts

Accelerating mRNA-Based Therapy Development with Scalable Purification of In Vitro Transcribed mRNA

This webcast features: Kelly Flook, Senior Product Manager, Purification Products, Thermo Fisher Scientific The diversity of potential mRNA-based therapies has led to increased interest in using synthetic mRNA as a tool in the treatment of multiple diseases, such as cancer, stem cell therapies, and infectious diseases. Nevertheless, obtaining larger quantities of synthetic mRNA for clinical treatment remains a challenge. Currently available mRNA purification methods are becoming a bottleneck for large-scale manufacture as the limits of research-scale purification techniques are realized.…

Ask the Expert: Translating Inhaled and Nasal Technologies for Biologics Delivery

Gastric delivery is unachievable for most biopharmaceuticals, so drug developers formulate biologics primarily for intravenous infusion or injection. However, inhaled and nasal delivery options are attracting considerable attention because they enable targeted delivery of a wide range of therapeutic proteins. On 23 June 2020, Mark Parry (technical director at Intertek) presented an “Ask the Expert” webinar that described critical considerations for inhaled and nasal delivery for biologics. Parry’s Presentation Because biopharmaceuticals are complex products, developers need compelling reasons to choose…

Ask the Expert: Ultrapure Gelatin Can Optimize Your Excipient Screening for Vaccine Formulation

In his 28 May 2020 “Ask the Expert” presentation, Jeroen Geeraerts (business development manager at Rousselot) highlighted that, as of May 2020, 118 candidate vaccines for the novel coronavirus (SARS-CoV-2) had reached clinical or preclinical evaluation. Of those, 11 use inactivated and live–attenuated approaches, which require strong stabilizing agents to maintain vaccine potency. Geeraerts explained why inactivated and live–attenuated vaccines require stabilizing agents and why vaccine companies prefer pharmaceutical-grade gelatin for such applications. Next, Geeraerts described how his company’s X-Pure…

Ask the Expert: An Innovative System for Advanced, High-Throughput Aggregate Analysis

Distinguishing aggregated active pharmaceutical ingredients (APIs) from other particle types is critical to evaluating a protein product’s stability, but standard characterization tools struggle to discriminate proteins from nonproteins with similar sizes, shapes, and morphologies. In a 25 June 2020 “Ask the Expert” webcast, Bernardo Cordovez (founder and chief scientific officer of Halo Labs) introduced his company’s Aura subvisible-particle analyzer. He explained how the device combines an innovative microscopy technique with sophisticated imaging software to characterize subvisible particles more quickly and…

CHOgro® High Yield Expression System: Achieve Higher Titers Faster in Suspension CHO Cells

This webcast features: Leisha Kopp, Applications Scientist, Mirus Bio Suspension Chinese Hamster Ovary (CHO) cells are often utilized for protein expression in biomanufacturing given their capacity for high-density growth in chemically defined media, human-biosimilar posttranslational modifications, and strong history of regulatory approval by the US Food and Drug Administration (FDA). However, many early stage researchers rely on HEK 293 systems for screening candidate compounds because of additional costs and time associated with production in CHO cells. The CHOgro® High Yield…

Enabling Large-Scale Production of Viral Vectors in the Gibco™ CTS LV-MAX Lentiviral Production System

This webcast features: Jonathan Zmuda, PhD, Director, Cell Biology, Life Science Solutions Group, Thermo Fisher Scientific The Gibco™ Cell Therapy Systems (CTS™) LV-MAX™ Lentiviral Production System enables scalable, high-titer production of lentiviral vectors using HEK293F-derived Gibco™ CTS™ Viral Production Cells adapted for high-density suspension growth in chemically defined, serum-free, and protein-free Gibco™ CTS™ LV-MAX™ Production Medium. Enhanced lentiviral production is enabled through the synergistic interplay of the LV-MAX components (including cells, production medium, supplement, enhancer, and transfection reagent), all of…

Single-Use Technologies: Innovation and Performance

The biotherapeutic market has been rapidly adopting single-use technologies to reduce risk and improve operational efficiencies. For more than 20 years, Thermo Fisher Scientific has pioneered single-use technologies for this industry. Our products have been proven to be robust and scalable from laboratory scale-up to current good manufacturing practice (cGMP) production applications, including single-use bioprocessing equipment, flexible containment, and rigid containment product portfolios. Our webinars will explore data, innovative products, and novel strategies featuring single-use solutions for the bioprocessing market.…

Efficient and Rapid Purification of E. coli Expressed Toxin Recombinant Protein Fragments

This webcast features: Andrew Lees, PhD, Founder and Scientific Director, Fina Biosolutions, LLC Tetanus toxoid (TT) is frequently used as a carrier protein for conjugate vaccines. TT contains strong T cell epitopes. They are toxoided protein and are not a uniform product because of specific toxoiding and purification processes. TT tends to aggregate with age and is not affordable to produce in quantities for research and early clinical work. TT heavy chain fragment C (rTTHc) is the C terminal fragment…

Viral Vector Empty Versus Full and Plasmid Quantitation Analytics for Accelerated Gene Therapy Time to Market

This webcast features: Joe Ferraiolo, Associate Director, Bioanalytics Applications, C Technologies, a Repligen Company Analytical technologies play a crucial role in accelerating gene therapy speed to market. Dilution steps during protein and DNA quantitation measurements represent the single highest source of accuracy and precision errors. The SoloVPE® device provides a dilution-free workflow that saves time, reduces deviations, and facilitates multisite alignment. Multiple case studies from major biopharmaceutical companies describe execution in process development, analytical labs, and directly on good manufacturing…

Figure Out Any Particle with Automated Counting, Sizing, Morphology, and Identification Using the Hound

This webcast features: Lisa Krapf, Field Automation Scientist, Unchained Labs Thorough particle sizing and analysis are essential steps in formulation development and the monitoring of manufacturing process controls. Traditional particle analysis techniques such as light obscuration do not provide morphological information that can be useful for classification. Transfer to manufacturing and scaling to production will necessitate different equipment and the potential introduction of extrinsic particles that may not have been observed previously. The combination of particle analysis with flexible options…