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Build it Right: A Quality Perspective on the Design and Build of a Viral Vector CDMO Manufacturing Facility

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…

Unveiling the Future of Bioprocessing: Cell and Gene Therapy Purification Strategies

Discover the cutting-edge advancements in bioprocess intensification and cell & gene therapy purification with this comprehensive custom report from Astrea Bioseparations. Explore the latest innovations and breakthroughs that promise to revolutionize the field. HCPure™ Host Cell Protein Clearance Resin: Bioprocess Intensification through Mixed-Mode Chromatography Delve into the world of mixed-mode chromatography and how HCPure™ Host Cell Protein Clearance Resin is transforming bioprocess intensification. Learn how this technology is enhancing purification efficiency and streamlining biomanufacturing. Enhanced Efficiency in Cell & Gene…

Can LC-MS Based PAT Remedy the Pain Points for a Bioprocess Engineer?

The past decades have brought a tremendous increase in new biologics and biotherapeutics that offer patients more efficient and safer treatment options than they had before. Such revolutionary innovations in biopharmaceuticals are to a large extent thanks to advancements in upstream research and development, which are important drivers of bioprocesses. But despite this unceasing progress, upstream bioprocess engineers continue to face challenges and pain points in their work. In this article, Magnus Wetterhall, Global Marketing Manager — Bioprocess at Waters…

Minimizing Lentiviral Vector Loss During the Purification Process Using an Innovative Nanofiber Adsorbent

This webcast features: Sujeong Yang, PhD, Viral Vector Lead, Senior Research Scientist, Astrea Bioseparations. The field of lentiviral vector (LVV)-based therapeutic applications, encompassing both ex vivo and in vivo gene therapy, is experiencing rapid growth. To meet the surging demand for LVV, it is imperative to address the bottlenecks associated with low LVV recovery and inadequate contamination removal. Traditional chromatography-based methods often suffer from poor step yield recovery, while non-chromatographic techniques may present challenges in terms of scalability and robustness.…

Enabling Next Generation Holderless Flat Sheet TFF

Traditional TFF cassette designs have been in use for more than 30 years. Reduce setup time, eliminate torquing and decommission time that traditional TFF cassettes require. TangenX SC is a new TFF device design that does not require a holder and eliminates torquing. It can help you: Reduce your TFF process set up time by 80% with a plug-and-play true flat sheet device Eliminate decommission time Easily scale from traditional PD cassettes because of the consistent path length Learn more…

Optimizing Perfusion Parameters for Intensified Production of CAR-T Cells in Ambr® 250 High-Throughput Bioreactor

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…

MaxCyte® Flow Electroporation® for Gram-Scale Transient Antibody Production in CHO-S Cells

High efficiency, scalable electroporation of CHO cells with MaxCyte enables rapid gram-scale protein production, extending the potential use of transient gene expression throughout antibody development. As the demand for therapeutic antibodies intensifies, methods for the rapid manufacture of high-quality protein are crucial. MaxCyte Flow Electroporation enables scalable and highly efficient transfection of clinically relevant cell lines producing grams of protein within two weeks. In this Application Note, we discuss some of the factors that are critical for high-yield transient gene…

Overcoming Obstacles in Viral-Vector Manufacturing: How To Design and Launch a Successful Program for Clinical-Trial Manufacturing

Experience with manufacturing viral vectors used for gene therapeutics is essential to mitigating risks in manufacturing of clinical trial materials. Collaborating with an experienced contract development and manufacturing organization (CDMO) with can help product developers design seamless and scalable vector-production processes. As authors from IDT Biologika describe here, a proven manufacturing platform and high-throughput analytical technologies help to ensure patient safety with products that meet high quality standards. The authors highlight the utility of digital polymerase chain reaction (dPCR), anion-exchange…

Modern Sensor Technologies for Viral-Vector Manufacturing: Improving Ultraviolet Photometric Detection of Full and Empty Adenoassociated Virus Capsids

Despite rapid progress, significant obstacles remain for viral-vector manufacturing, including the need for effective separation of full and empty viral capsids. Optimizing that step is difficult but critical to achieving good yields of functional vectors. The biopharmaceutical industry has rapidly developed enhanced resins, matrices, and methods for such processes. As this author from EnVision Instruments explains, dual-channel, in-line photometers based on modern UV-LED light sources provide a powerful tool for process scientists working to address current limitations. He highlights the…

Aseptic Closed Small-Volume Processing: Today’s Options

Small-volume biopharmaceutical processes continue to grow as more biopharmaceutical, cell therapy and gene therapy companies develop products. A 2021 Association for Regenerative Medicine (ARM) report states that there are 1,085 cell, gene and tissue-based therapy developers worldwide. These companies are engaged in many small-volume (<10L) processes including early-stage drug development and autologous therapies. The increase in small-volume processes coincides with the ongoing need to create fast, reliable aseptic closed systems. Historically, few convenient options have existed to facilitate sterile processing.…