Author Archives: BPI Contributor

“Breez”ing the Way into Process Development with Perfusion Technology

This webcast features: Kevin Lee, Co-Founder, Principal Scientist, Erbi Biosystems The priority of speed to market is often at odds with issues around development resources, facility space, and infrastructure for both development and manufacturing. Continuous bioprocessing provides solutions for many of these challenges in certain applications, but to deliver on this promise we need fit-for-purpose tools and technologies to enable process development and provide reliable transfer to commercial manufacturing. The migration to continuous processes in process development is further hindered…

Setting the Stage for Electronic Data Exchange

Every day, drug manufacturers must consider and address a wide range of challenges and prospects including complex regulatory requirements, intense cost pressures and the business opportunities offered by novel product classes. Transforming biopharmaceutical manufacturing with integration of intensified, continuous, predictive and autonomous operations is one solution that holds promise for streamlining operations, exploring new therapeutic modalities and meeting regulatory expectations which continue to evolve. Digitization and automation, key elements of Bioprocessing 4.0, will be essential for this transformation, in which…

Automation of a Next-Generation Sequencing Method for Cell Line Species Identity

This webcast features: Dr. Christine Mitchell, Scientific Fellow, Analytical Development, WuXi Advanced Therapies As the gene and cell therapy market continues to expand, affordability and accelerated turnaround time (TAT) become increasingly important in the industry. Despite the escalating diversity of therapeutic modalities, the criticality of a robust cell bank remains a pivotal starting point for many biological products. The integrity of species identity for cell lines is a critical quality attribute for many cell and gene therapies, and with regulatory…

Selecting the Best Transfection Method

When to Use Transfection Reagents, Viral Transduction or Electroporation No single delivery method is ideal for all situations, but researchers may routinely employ a suboptimal approach for the sake of familiarity or to avoid any start-up costs associated with new methods. In this white paper, we will describe three methods (chemical, electroporation and viral transduction) and highlight the Mirus Bio TransIT® and VirusGEN® transfection reagents and Ingenio® EZporator® Electroporation System, which are both easy to use and cost-effective. Additionally, we…

Virtual Demonstration of the BioSMB Multi-Column Chromatography Platform

This webinar provides a virtual demonstration of the BioSMB multi-column chromatography platform — a fully scalable single-use solution that reduces resin usage and enables manufacturers to explore continuous processing. The demo starts with an overview of the BioSMB PD system for small-scale manufacturing and then continues with the BioSMB Process systems for clinical and commercial manufacturing. Click here to watch this virtual demonstration.

Ask the Expert: High-Yield mRNA Processing — From Plasmid to Highly Purified Product

Interest in industrial-scale production of messenger RNA (mRNA) has surged amid rapid development of mRNA-based vaccines against SARS-CoV-2. During an 18 February 2021 Ask the Expert presentation, Aleš Štrancar (chief executive officer of BIA Separations, a Sartorius company) reminded attendees that no platform approach yet exists for mRNA production and that much remains to be learned about manufacturing such products at commercial scales. He described current production challenges and shared BIA’s efforts to devise flexible mRNA purification tools. Štrancar’s Presentation…

Ask the Expert: Leveraging Cloud Capabilities to Execute CHO Cell Culture Experiments

Process development teams have relied for decades on benchtop bioreactors to perform mammalian-cell–culture experiments; however, doing so requires significant resources and staffing. During a 24 February 2021 presentation, Deborah Pascoe, PhD, vice president of operations at Culture Biosciences (Culture), explained how to leverage her company’s high-throughput, cloud-connected bioreactors to execute Chinese hamster ovary (CHO) cell cultures with high reproducibility and scalability. Pascoe’s Presentation Pascoe described her company as an extension of a customer’s laboratory. After technology transfer, Culture and a…

Virus-Like Particle Production in Insect Cells Using the Baculovirus Expression System: Addressing Challenges across the Workflow

This webcast features: Maya Yovcheva, R&D Scientist, Cell Biology, Chantelle Gaskin, Field Applications Scientist, Purification, and Florian Durst, Sr. Field Application Specialist, Pharma Analytics, Thermo Fisher Scientific Being part of the newer generation of vaccines, virus-like particles (VLPs) have proven to be effective in humans as well as animals. VLPs mimic the structure of the virus particles they are derived from and are highly immunogenic, but they lack the virus genomic material which gives them a favorable safety profile. The…

CHO Cell Culture Media & Feeds

Media selection is a crucial step in optimizing and maximizing your upstream process. Our chemically defined catalog media portfolio offers a comprehensive range of off-the-shelf products to support all of your CHO production processes, including fed batch and perfusion mode. Learn more.

Manufacturing a Recombinant Retrovirus: Downstream Purification Process Development through GMP Implementation

This webcast features: Mark Fitchmun, President and CEO, Somatek, Inc. Purification of enveloped viruses and virus-like particles presents several challenges due to their large size and complexity. In this webinar, a case study will be presented and will detail the importance of resin screening, endonuclease treatment, process development, and the scale-up purification of a retrovirus-like particle intended for use in human subjects. The resulting current good manufacturing practice (CGMP) compatible process required approximately four hours to purify 240 L of…