Webinars

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…

BioProcess Insider State of the Industry – Live from Biotech Week Boston

Ukraine escalation, COVID drop off, cell and gene approvals, and sustainability efforts were the focus of the latest BioProcess Insider State of the Industry discussion at BPI Boston Frank Orlowski, Director of Business Development at Latham Biopharm Group, Miriam Monge, Head of Marketing Fluid Management Technologies at Sartorius, and Joseph Scott, Vice President, Supply Chain at Avid Bioservices, sat down with BioProcess Insider’s Dan Stanton to discuss the geopolitical issues affecting the biomanufacturing space. In front of a full crowd…

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…

Robust Methods for Stability and Identity Testing of Cell and Gene Therapies

This webcast features: Sameer Kalghatgi, PhD, Director of Molecular Biology, WuXi Advanced Therapies. Genetic stability and identity testing are necessary for novel cell and gene therapies to achieve regulatory approval. Sanger Sequencing, human cell line identification using short tandem repeats (STRs) and next generation sequencing (NGS), are important tools for identity and stability testing but must be implemented in a reproducible way. For regulatory approval, the identity and stability of transfected DNA inserts must be confirmed. Sanger Sequencing is widely…

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…

Bioprocess Considerations for Large Scale Transfection

This webcast features: Geddy Hamblen, Field Applications Scientist, Mirus Bio. As demand for viral vectors has grown in recent years, larger production scales are increasingly common. As processes scale, transient transfection must also scale to match. The VirusGEN® family of transfection products, developed by Mirus Bio, has been used successfully at scale in clinical manufacturing and brings unique advantages leading to higher titers and a more robust manufacturing process. In this webinar we will discuss: Challenges and solutions for transfection…

Screen Smarter Not Harder: Expand and Accelerate Your Cell Line & Viral Vector Screening

This webcast features: Andres Castillo, Portfolio Manager, Sartorius & Shanya Jiang, PhD, Portfolio Manager, Sartorius. Viral-based therapies like gene therapy or vaccine development require broad and thorough process screening before transitioning into optimization. Screening sets the stage to choose the best performing media, key parameters, and cell lines with minimal variability before optimizing the critical process parameters (CPPs) and critical quality attributes (CQAs). In this 15 minute webcast, Andres Castillo and Shanya Jiang, PhD from Sartorius present an automated and…

Streamlining of Process Characterization Using an Automated Reactor System

This webcast features: Kyle Deluca, Senior Scientist, Engineering & Felix Milman, Specialist, Engineering, Merck. In an effort to improve the efficiency of large molecule process characterization work, the Bioconjugation and Chemistry Commercialization team at Merck looked to automate steps involved in the production of its vaccine pipeline candidates. The actions taken by the team included installation of an automated reactor system that would provide new process capability and allow reactions to be completed outside of business hours, while improving process…