Webinars

Residual DNA/Protein and Mycoplasma Detection in Cell and Gene Therapy Products

This webcast features: Hong Li, PhD, Director of Assay Transfer and Validation, WuXi Advanced Therapies. Process-related impurities such as host cell DNA and host cell proteins may have adverse effects on product quality and pose safety concerns for cell and gene therapeutic (CGT) products. These impurities must be removed to the lowest possible level in order to meet regulatory requirements, not only to ensure product safety, but also to help understand the capabilities of the manufacturing process. Therefore, throughout product…

Ensuring Leak-Free Performance During Tissue Container Shipping Utilizing ASTM D4991

This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex. Companies in the fields of tissue engineering and cell therapy find that when standard, off-the-shelf labware containers are used to transport therapies, the container seal can fail during shipment. For a live tissue or cell sample being shipped to a hospital or clinic as part of a treatment, this can be a catastrophic failure that can lead to damaged samples, surgical delays, and poor patient outcomes. When selecting containers for…

Benefits of Hollow Fiber Filter Cell Expansion

This webcast features: Stuart Gibb, PhD, Scientific Strategy Lead, Terumo Blood and Cell Technologies. Cell therapy requires cells to be healthy and active throughout the entire manufacturing process for optimal endpoint efficacy. A key part of this process is cell expansion. The Quantum Flex hollow-fiber filter technology provides an effective cell culture environment to provide ready access to fresh media, waste removal, and gas exchange over micrometer distances and works with suspension and adherent cell culture. In this environment, we…

Flexible and Customized Approach to Lentiviral Vector Development and Manufacture Through a Well-Established Platform

This webcast features: Natalia Elizalde, PhD, Business Development/Project Management Director & Rakel Lopez de Maturana, PhD, Qualified Person/Regulatory Director, VIVEbiotech. VIVEbiotech is fully specialized in the development and GMP manufacture of lentiviral vectors along EMA and FDA requirements. Having worked for more than 35 international biotech and pharma companies since 2015, VIVEbiotech has developed its service approach in a customer-centric manner, so that all our activities are developed to satisfy the real requirements of our partners. In this webinar, VIVEbiotech…

Shaken, Not Stirred: Rocking Motion Versus Impeller Technology and What is Optimal for Cell Cultivation

This webcast features: Tobias Schenk, PhD, Product Manager, Rocking Motion Bioreactors and Consumables, Manufacturing BT Instruments, Sartorius Stedim Biotech. Cell cultivation might be a laborious process, requiring optimization at various stages to achieve the desired cell densities and satisfactory yields of the final product. Optimization steps can be undertaken by improving cell culture media and buffers, inoculation cell densities, as well as specific cultivation run parameters such as temperature, pH and DO values, or changing the duration of the run…

Less is More in mRNA Therapeutics: Developing Big Ideas in Small Scale

This webcast features: Linda Mathiasson, Strategic Customer Lead, Cytiva. Messenger RNA technology has changed the way therapies are developed. The overall potential of mRNA is clear, with mRNA therapeutics being developed in many research areas. The speed and potential cost gains of mRNA technology make it an interesting technology for personalized medicine. However, much of the current equipment used in manufacturing is repurposed from the biotech industry and is designed for much larger scales than needed for mRNA. In this…

Small Format Connections for Optimizing Manufacturing

This webcast features: Ray Rendon, Application Development Manager, Colder Products Company. Application Development Manager, Ray Rendon, examines areas for improvement in small format manufacturing processes that are commonly used in cell and gene therapies, sampling, or other small format manufacturing. Optimization of these processes can be achieved with tube welding alternatives like single-use aseptic connectors. In this webinar, you will learn: Key considerations when reviewing your existing processes, such as the total cost of ownership of tube welded connections and…

Streamlined AAV Manufacture: From Plasmid Design to GMP Production

This webcast features: Bo-Jhih Guan, PhD, Senior Scientist, Department of Viral Vector Process and Technology Development, WuXi Advanced Therapies. Adeno-associated virus (AAV) vectors are important gene delivery tools for gene therapies. To ensure that novel treatments can be effective and can reach as many patients as possible, AAV vectors must be produced at high quality and high titres – and manufacturing approaches must keep pace with an increased demand for treatments. AAV quality and titre can be improved by optimizing…

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…