Downstream Archives - Page 7 of 8 - BioProcess InternationalBioProcess International

Impact of Single-Use Tangential Flow Filtration in Downstream Bioprocessing

This webcast features: Michael LaBreck, Sales Director, Repligen TagenX Products Single-use solutions are fast becoming platform in bioprocessing as a response to pressure to optimize process economics and process efficiencies. Implementing single-use alternatives in tangential flow filtration (TFF), a critical step in downstream bioprocessing for concentration and diafiltration (buffer exchange), is a major part of this transformation. Repligen TangenX™ SIUS™ Single-use Cassettes are the first purpose-built cassettes designed for tangential flow filtration. This webinar will demonstrate how deploying these innovative…

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

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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.…

Continuous Chromatography of MAbs Using BioSC: Process Design and Regulatory Considerations

by BPI Contributor

This webcast features: Vincent Monchois, Strategic Project Director, Biopharma, Novasep Challenges in bio-manufacturing up to commercial stage include improving lead times, securing the process, improving productivity, and reducing COGs. The implementation of a continuous manufacturing process is a viable solution to address these challenges. The chromatography step represents one of the key stages of a manufacturing process for (bio)pharmaceutical compounds. Continuous chromatography was originally developed by the Petroleum industry in the 1960s and has been successfully implemented in the Food-processing…

Principles and Troubleshooting of Large Scale Column Packing

by BPI Contributor

This webcast features: J. Kevin O’Donnell, PhD, Process Chromatography Support Manager, Tosoh Bioscience This presentation focuses on the packing of process scale chromatography columns. Including general principles of column packing, common packing techniques used in packing process scale columns, qualification and evaluation of the packed column, and the troubleshooting of issues common to large scale column packing.

Simulation and Optimization Software for a Chromatographic Step

by BPI Contributor

This webcast features: Thomas Flouquet, Area Sales Manager/Application Specialist for low pressure chromatography BioSC® Predict is the first simulation and optimization software for the development of chromatography processes dedicated to the purification of biopharmaceuticals. Its innovation was recognized at the Achema 2015 Awards in the Pharmaceutical Engineering category. With a few clicks, the user can easily generate batch, parallel batch or continuous chromatography recipes and directly run them on BioSC® technology, with any adsorption media. BioSC® Predict is driven by…

Production Scale Prepacked Chromatography for Use with 1000 L and 2000 L Bioreactors

by BPI Contributor

This webcast features: Fletcher Malcom, Associate Director of Product Management at Repligen. The technical and economic benefits of ready-to-use, pre packed chromatography columns at bench- and small-scale have been proven and documented. The question remains: how do we scale up to production-scale? Now, for the first time, the new OPUS® 45 and 60 cm columns can purify a feed stream from a 1000L – 2000L bioreactor. This Ask the Expert webcast will show how the unique design of these GMP-scale…

A New Incompressible Protein A Resin to Improve Downstream Productivity in Single-Use Applications

by BPI Contributor

This webcast features: Dr. Kiran Chodavarapu, Bioprocessing Business Development Manager at W.R. Grace. Implementation of single-use technologies and higher antibody titers upstream have put increasing pressure on downstream processes to improve efficiencies and keep pace with upstream advancements. There continues to be a lag in the development and adoption of single-use technologies in downstream – particularly in the area of chromatography. To help achieve the vision of a fully disposable and flexible manufacturing platform that addresses the current bottleneck in…

Reducing the Host Cell DNA Quantitation Bottleneck: Approaches for Improved Sample Preparation and Throughput

by BPI Contributor

The removal of impurities arising from host cells used for the production of biopharmaceutical products is a crucial step in the purification process. Regulatory guidance for products produced in cell culture specifies that residual host cell DNA content in the final product should be as low as possible. Because of the low sample throughput typical of most quantitative DNA assays, host-cell DNA quantitation can become an analytical bottleneck during process characterization.

In this webcast, speakers will discuss a qPCR-based system for highly sensitive, accurate quantitation of residual host-cell DNA from a variety of cellular production systems, including Chinese Hamster Ovary (CHO), E. coli and Vero cells. Case studies will be presented that demonstrate DNA recovery from highly complex test sample matrices, typical of those in biopharmaceutical manufacturing environments. Options for automated sample preparation, testing results from samples typical of a monoclonal antibody purification process and results from an external validation study, executed according to ICH guidelines, will also be reviewed.