Ask the Experts

Improving Protein Folding Control and Scalability Using imPULSE Mixing Technology

This webcast features: Anthony Hawrylechko, Director of Microbial Bioprocess, Cytovance Protein folding by dilution is a common approach used in the manufacturing of biologics derived from microbial expression systems. This typically involves the solubilization of a washed inclusion body preparation containing the concentrated product polypeptide with a strong chaotrope or detergent solution. The denatured, inactive product solution is then diluted into a combination pH and red/ox buffer solution. Within this environment, the molecular diffusion rates of chaotrope, buffer components, and…

Effective Deployment of OPUS Pre-Packed Chromatography Columns for Bench-Scale Process Development and Process Validation

This webcast features: Tim Schroeder, Director, Product Management at Repligen GmbH Formerly Atoll pre-packed columns, OPUS® pre-packed chromatography columns for process development are used in all steps of downstream development, including screening, process validation and viral clearance, scale up and sample preparation. This webcast will demonstrate how OPUS® ValiChrom Columns, glass pre-packed columns that are exact scale-down models of corresponding full-scale chromatography columns, are ideal for process validation including viral clearance. It will also demonstrate how OPUS® RoboColumns®, miniaturized columns…

Ultimate Flexibility from Pre-Packed to Unpacked: OPUS 45R and OPUS 60R Columns

This webcast features: Fletcher Malcom, Director of Product Management, Repligen With an innovative side port that allows for easy resin unpacking, OPUS® 45R and OPUS® 60R Columns provide the ultimate flexibility in pre-packed column technology. Without compromising chromatographic performance or cleanability, the new feature helps mitigate the risk of implementing pre-packed columns in CGMP settings, and allows for re-use of the unpacked resin in other columns. This webinar covers test results on chromatographic performance, bioburden testing, shipping tests and simple…

Enabling Custom Solutions for Downstream Processing for Future Therapies: AAV Case Study

This webcast features: Orjana Terova, Purification Product Manager, Thermo Fisher Scientific There is a need in the industry for a standard purification strategy for the manufacture of novel molecules including viral vectors and oligomeric therapies. Working with customers, Thermo Fisher Scientific has developed innovative purification resins through the POROS™ custom resin program and CaptureSelect™ ligand technology. This combination of ligand and resin development has allowed for development of platform purification processes that increase productivity and improve product yield for gene therapies.…

Challenges of Scale Up and Development of Insect Cell Culture and BEVS

This webcast features: Sharyn Farnsworth, Associate Principal Scientist, FUJIFILM Diosynth Biotechnologies A strategy for scale up and implementation of Insect Cell Culture (ICC) should be assessed at the earliest stages of process development as there are a different set of challenges in the culture of ICC and BEVS versus a CHO culture and a limited number of vendors experienced enough to guide you through the adventure of manufacturing ICC. Each system has a unique problem set ranging from which cell…

The Total Cost of Buffer Preparation and Handling

This webcast features: Eric Langer, Managing Partner, BioPlan Associates, Inc. Most bioprocessing facilities consider in-house preparation of buffers and bulk liquids to be a core bioprocessing task. However, some companies are now outsourcing liquid manufacturing, by purchasing ready-to-use materials from vendors or hiring CMOs to prepare these. Buffers and bioprocessing liquids are one area of upstream production operations that is seeing an increase in outsourced operations. Bulk liquids can be a bottleneck in downstream processing, with buffer volumes often required…

Single-use XCell ATF Systems for Continuous Processing: 100% Cell Retention, 80% Faster Set-Up

This webcast features: Christine Gebski, Vice President, Product Management and Field Applications, Repligen In today’s flexible manufacturing environments and to improve manufacturing cost of goods, many companies have implemented single-use equipment. To meet these changing customer requirements, the XCell™ ATF 2 and ATF 6 are now available in single-use formats. The XCell ATF Single-use systems deliver the same cell culture performance as the stainless steel systems but with 8x faster set-up time and a simplified autoclave-free implementation workflow. These elements…

Taking Medium and Feed Development Beyond Maximizing Protein Titer to Optimizing Glycan Distribution and Simplifying Process Scale-Up

This webcast features: Serena Fries Smith, Process Science Manager, Thermo Fisher Scientific In the early 2000s when many processes were struggling to achieve 1 g/L, maximizing titers was the industry’s biggest challenge and was essential to having favorable cost of goods and an economically viable product. Over the last 1–15 years, the industry has made significant advances in media and feeds. Due to these advancements, today a standard fed-batch process can typically achieve 3 g/L and some processes are achieving…

Reveal Information That Gives Insights: New Approaches to Sub-Visible Particle Characterization

This webcast features: Josefina Nilsson, Head of EM Services,  and, Gustaf Kylberg, Product Manager – MiniTEM, Vironova Sub-visible particle characterization is essential when comparing sample quality after different purification steps or for the understanding of product stability. Analysis performed with MiniTEM provides both morphology and accurate quantitative data that can help speed up process and formulation development. In this webinar you will learn: How MiniTEM automatically images, detects and classifies a large number of particles resulting in statistically significant and…

Improving Single-Use Bioreactor Design and Process Development: New Research Towards Intensifying Seed-Train and Scale-Up Methods Using 5:1 Turn-Down

This webcast features: Surendra Balekai, Senior Global Product Manager, Thermo Fisher Scientific Bioproduction Operating bioreactor vessels at low working volumes (low turn-down ratio) is often desirable but brings about challenges in regard to mixing, mass transfer, and process control. Research done toward optimizing cell culture has provided methods to improve performance and control when operating under these conditions. Implementing bottom heat exchange, making changes to impeller angle and height, taking advantage of the unique Thermo Fisher drilled-hole sparge design, and…