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“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…

Is your cell and gene therapy manufacturing at risk for SARS-CoV-2?

New US FDA guidance recommends evaluating process and product for transmission potential.  Though respiratory viruses such as SARS-CoV-2 are not known to be transmitted by implantation, transplantation, infusion, or transfer – i.e., the common route of administration for cellular and gene therapies – there is much about the novel coronavirus that is unclear. We do know, however, that SARS-CoV-2 has been shown to infect and replicate in cells commonly used in vector production. For developers of cellular and gene therapies that use vector delivery, this…

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…

How Capacitance Measurement Can Improve Viral Vector and Virus-Based Vaccine Production

With the increasing development of viral vector and virus-based vaccines, technologies that help to manufacture and scale up these types of vaccine quickly and cost-effectively have become more critical. By accessing this special report from Aditya Bhat, a capacitance technology expert at Aber Instruments, you will find out how in-line capacitance measurement can produce a detailed fingerprint of cell culture processes and how that can benefit vaccine production. From case studies involving baculovirus, AAV, and measles, you will discover why…

Successful biosimilar development requires an outsourcing partner with the right experience

Demand for biosimilars is expected to increase significantly in the coming years, particularly in the United States. Developing new biosimilar candidates is a challenging endeavor that requires partnerships with outsourcing partners that have deep protein science, analytics, and process engineering expertise. Avid Bioservices has successfully supported biosimilar development for nearly a decade and is further expanding its capacity to provide manufacturing services from the bench through larger-scale commercialization. Anticipating Strong Growth in Demand for Biosimilars The value of the global…

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.

Rapid Development of Viral Vector Production Processes: Iterative Parameter Optimization

With recent developments and successes in cell and gene therapy, the biopharmaceutical industry is facing increased demand for safe and efficient delivery systems (1). Viral vectors, including adenoviruses (AV), adenoassociated viruses (AAV), and lentiviruses (LV), are among the most common delivery agents because they infect mammalian cells efficiently. Suspension cultures have become a popular choice for robust and scalable viral manufacturing systems. Using stable cell lines that integrate all or part of the viral production elements adds further benefits by…

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…