This webcast features: Jessica Waller, PhD, Principal Scientist Biologics Development, Bristol Myers Squibb. Bispecific antibody configurations with multi-targeting capabilities are evolving as new generation biologic therapeutics with potential for enhanced efficacy and reduced toxicity. Significant challenges arise with downstream purification of these molecules due to a unique panel of product-related variants or mispaired species that must be monitored and cleared in product pools. Viral clearance capability is another critical component when developing a downstream process, as mammalian CHO-derived products have…

This webcast features: Thomas Valorose, Senior Product Manager, Astrea Bioseparations. Despite considerable advances in downstream purification for MAbs and other recombinant proteins from various expression systems, there remains a need for effective removal of process and product related impurities that could impact product safety, stability, and efficacy. Many workflows today utilize multiple steps to polish their product, including ion exchange and hydrophobic interactions. Utilizing mixed-mode purification techniques, Astrea Bioseparations delivers a solution that has several advantages over traditional workflows. By…

This webcast features: Manuel Matos, PhD, Field Application Scientist, Thermo Fisher Scientific and Marco Baldazzi, DSP Research Laboratory Technician, Menarini Biotech. While protein A affinity chromatography is the most commonly used method for monoclonal antibody (MAb) capture in clarified harvest coming from CHO cell cultivation, one significant challenge is the high cost of the media required when using these resins. Therefore, it’s crucial to evaluate alternative strategies that may reduce costs and increase productivity without affecting product quality attributes. In…

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…

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…

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…

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…

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…

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…

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.…