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.