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.…

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

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

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

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

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

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

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.

KrosFlo® Research IIi Tangential Flow Filtration System

Spectrum Laboratories’s the KrosFlo ®Research IIi Tangential Flow Filtration System (KRIIi) is the only commercially available system with hold up volumes as low as 1 milliliter. Spectrum’s innovative, semi-automated TFF System, is ideal for small volume, R&D scale microfiltration and ultrafiltration. The KRIIi system can be used to concentrate and wash, viruses, proteins, nano-particles, and cells, at low volumes, with remarkable recovery rates. Hollow Fiber Tangential Flow Filtration is fast becoming the preferred method of large and small scale processing, due to outstanding efficiency and easy scalability compared to cassette or centrifugal devices.

Scale-Up of Single-Use Depth Filtration Systems

Process development engineers are responsible for developing scale-up strategies for efficient and cost-effective manufacture of biological and bioprocess-derived products at bench-scale, pilot scale and at manufacturing scale. A central unit operation in the production of these various therapeutic proteins is cell clarification using depth filtration. Recently, single-use depth filtration technologies have been developed, at scales ranging from the lab, to R&D, process development and on to manufacturing.

In this educational webcast, Laura Brown, Scientific Application Support Specialist II with 3M Purification, will provide guidelines for scaling-up of single-use depth filtration systems, and will review the commonly used single-use depth filtration products used for biopharmaceutical manufacturing.

Applied Biosystems® GoPure™ Prepacked Chromatography Columns

Convenient, flexible, and efficient purification of biomolecules

GoPure™ Pre-packed Columns: A high performance, flexible purification platform

Single-use technologies have been widely utilized in upstream processes for many years. Interest in improving operational efficiency, speeding facility turn around and elimination of product carryover risk is now driving adoption of ready-to-connect filtration and purification modules in downstream processing.For chromatography, performance and flexibility that is equivalent to traditional self-pack columns is a prerequisite for use in multiproduct facilities. This webcast will describe GoPure™ Pre-packed Chromatography Columns and a custom packing process for third party resins. Case studies will be presented that demonstrate column packing process stability and scalability.