This webcast features: Derrick Katayama, Lead Scientist, Formulation Development, Samsung Biologics. As the global biopharmaceutical market rapidly expands, the increasing demand for drug development underscores the significance of effective assessment tools for selecting biologic compounds with adequate stability and developability. In response to these critical requirements, Samsung Biologics offers cutting-edge technology and an innovative approach from the early development stages with its advanced development platform, resulting in streamlined development time and costs. In this webinar, Samsung Biologics explores its proprietary…

This webcast features: Chris Berger, Executive Director, Quality Viral Vector, Avid Bioservices. The design and build of a facility to support the clinical and commercial manufacturing of advanced therapies is fundamentally important to the success of those projects. In many cases, a retrofit of an existing mammalian therapeutic manufacturing facility may introduce an unreasonable amount of risk into the manufacturing processes for advanced therapies, which can end up delaying the commercialization of such therapies. Constructing a new facility can often…

This webcast features: Julia Hengst, PhD, External Collaborations Manager, Cell Culture Technologies, Sartorius. The demonstrated efficacy of chimeric antigen receptor CAR-T cells against hematological malignancies has led to an increasing number of approved products and further research into additional indications. Despite recent advances, reaching therapeutic doses using ex vivo expansion of patient CAR-T cells remains challenging and represents the longest phase of manufacturing. Scalable expansion processes that maximize CAR-T cell growth are therefore required to reduce vein-to-vein time and support…

This webcast features:, Jun Tian, PhD, Vice President, Process Development, WuXi Biologics. To progress a biological product to BLA stage and on to commercialization, several critical activities must be undertaken and key milestones must be met during late-stage development. Using the experiences from the development of 100+ late-stage programs and the successful commercialization of 17 biological products, this webinar will share the perspectives gained and review some of the innovative process development, characterization, validation, control strategies, product quality modulations, and…

This webcast features: Samyuktha Shankar, Scientist II, Field Applications, BioProduction Group, Thermo Fisher Scientific. Digital PCR (dPCR) technology is being increasingly adopted in research, diagnostics, bioproduction, and environmental testing for absolute quantitation of nucleic acids. In this webinar, Thermo Fisher Scientific will discuss leveraging dPCR for absolute quantitation for lentiviral samples. They’ll demonstrate how this technique reduces variability, and improves accuracy and analytical sensitivity, even in high-background conditions. Key Takeaways: Leveraging LTR-based quantitation to enable correlation of total (genomic) and…

This webcast features: Patrick Nieuwenhuizen, Director, Principal Consultant, Quality Management & Compliance & Gerardo Gomez, PhD, Director, Service Line Lead, QMC, PharmaLex. Pharmaceutical manufacturing facilities, regardless of where they are, must meet GMP principles and procedures. There are, however, many other important and often poorly understood considerations with facility design. Beyond quality and compliance and country-specific expectations, facility design has a huge impact on decisions that both the sponsor and the contract manufacturing organization (CMO) must make. The issues faced…

This webcast features: Scott Estes, Head of Cell Line Development, Asimov. Traditional cell line development to support bioprocessing has typically relied on a “one-size-fits-all” vector, which can streamline development, but in most cases can lead to suboptimal expression levels, particularly for complex multi-specific molecular architectures. The commercial consequences are increased cost of goods, reduced facility flexibility, and in the worst case the inability to support commercial demand. In this webinar, Asimov presents their CHO Edge platform, which builds on the…

This webcast features: Kathleen McLaughlin, Senior Scientist, BioProcess R&D, Merck & Hironobu Shirataki, PhD, Senior Consultant, Scientific Affairs, Global Marketing, Bioprocess Division, Asahi Kasei Medical. There are two presentations during this webcast. Evaluation of the Planova™ BioEX Virus Removal Filter in Continuous Bioprocessing of a Monoclonal Antibody by Kathleen McLaughlin Standard batch monoclonal antibody biologics manufacturing processes are costly and time-consuming. A switch to intensified continuous processing enables much higher productivity, notably > 1.5 g/L/day over 25+ days of bioreactor…

The gene therapy industry has predominantly focused on rare diseases, but recently there has been a shift to prevalent diseases covering a much broader patient population. This is largely in hopes to drive down the cost of therapy as well as minimize the financial risks to therapy developers. With the current clinical trials pipeline being dominated by therapies for larger populations, the industry must recognize that our current manufacturing methods cannot efficiently produce the amount of material needed to treat…

This webcast features: Sofia B. Carvalho, PhD, Senior Research Associate, iBET. The expanding landscape of viruses and virus-like particles (VLPs) holds great promise for the development of safe and effective vaccines for a wide range of diseases. To keep up with the bioprocess progress requirements and growing regulatory constraints, it is critical to improve high-throughput in-process product quality control and vaccine manufacturing monitoring. There is a current need for novel and robust analytical tools in this area. iBET has a…