Ask the Experts Archives - Page 24 of 30 - BioProcess InternationalBioProcess International

Scaling Up? No Problem with New 80cm Diameter Pre-packed OPUS Columns

This webcast features: Fletcher Malcom, Director of Product Management, Downstream Technologies, Repligen The technical and economic benefits of ready-to-use, pre-packed chromatography columns have been proven and documented. The question remains, how large can we go? This presentation will show how the unique design of the new 80cm pre-packed OPUS column delivers chromatographic performance, and how usage can result in substantial cost and time savings for clinical and commercial scale manufacturing.

Advantages of Fluoropolymer Single-Use Systems

by BPI Contributor

This webcast features: Eric Isberg, Director of Life Sciences, Entegris There remain significant performance risks restricting the use of disposables in bioprocessing. These factors include bag breakage, which is particularly evident in cold temperature applications; concerns around E&L and material purity; and use of materials which are incompatible with the process itself. Improved plastics are required to meet existing and future process needs; fluoropolymers appear to be very promising to achieve these goals. Fluoropolymers’ unmatched characteristics are inherent to their…

Developing a Whole Genome CRISPR Screen to Improve CHO Cells for Biomanufacturing

by BPI Contributor

This webcast features: Jamie Freeman, PhD, Product Manager, Horizon Discovery While great strides have been made in increasing the yield of biotherapeutic proteins, these have been achieved mainly through process improvement with a particular focus on media and feed strategies. Aside from single gene knockouts to allow for metabolic selection systems, the CHO host itself remains largely unchanged from that which was used thirty years ago. This webcast will cover how Horizon Discovery has used the recently released annotated sequence…

Integration of Cell Line, Process and Analytical Technologies to Speed Development and Clinical Supply of Emerging Therapy Products

by BPI Contributor

This webcast features: Stewart McNaull, senior vice president of Business Development, KBI Biopharma, Inc. With biopharma’s ever-evolving pipeline of novel protein therapeutics, such as bi-specific antibodies, multimeric proteins, Fc-fusion proteins, and advanced monoclonal antibodies, CHO cells are being pushed to their productivity limits in drug development and manufacturing. Biopharmaceutical companies working on these promising new therapies increasingly struggle with development challenges such as weak protein expression, low-yield purification steps, and poorly optimized analytical techniques. As innovators address these challenges, robust…

Important Considerations in Successful Viral Clearance Studies

by BPI Contributor

This webinar features: Esha Vyas, Field Applications Manager, Asahi Kasei Bioprocess America Virus filtration is a critical unit operation in the manufacture of biotherapeutic products. Rigorous and careful validation of this process-dependent step is necessary to demonstrate that the selected virus filter meets regulatory requirements. Thoughtful design and implementation of spiking studies are imperative to successful validation, and these studies may include consideration of various robustness and process parameters. Overall, the study design should be conducted as a representative scaled-down…

Planova BioEX: Leading the Next Generation of Virus Filters

by BPI Contributor

This webcast features: Daniel Strauss, PhD, Principal Scientist, Research and Development group at Asahi Kasei Bioprocess America Virus filtration is a critical unit operation in the manufacture of biotherapeutic products owing to its capability to remove a broad range of viruses. Selection of virus removal filters based on filterability and virus removal performance over a range of process conditions ensures predictable processes. The Planova™ BioEX filter shows high flux with minimal flux decay for some of the most challenging products…

Ask the Expert: Purification of Antibody Fragments Using Amsphere A3 Protein A Resin

by Gerald Platteau

In an “Ask the Expert” webinar on 13 September 2017, Gerald Platteau of JSR Life Sciences described the use of Amsphere A3 resin to purify antibody fragments. He explained the molecular binding mechanism for VHH singledomain antibodies and compared dynamic binding capacity (DBC) data with those of other affinity resins. Platteau’s Presentation For full-size monoclonal antibodies (MAbs), the standard capture step is based on protein A. Its binding to the Fc region has been well described as taking place at…

Ask the Expert: Single-Use Bag Permeability Testing in Cryopreservation Conditions

by Mike Johnson

In BPI’s “Ask the Expert” webcast on 4 October 2017, Mike Johnson (market development manager at Entegris Life Sciences) discussed single-use bags and gas permeation. Johnson’s Presentation Permeation rates are a function of fluid properties, the type of material being penetrated, and application temperature. Standardized test methods used to determine permeability characteristics include ASTM D1434 and ASTM D3985. A fixture in Entegris’s test apparatus holds a sample plaque that is flanked upstream by high-pressure gas and downstream by a sensor…

Evaluation of the “Scale-Out” Biomanufacturing Strategy from Early Clinical Stage to Commercialization

by BPI Contributor

This webcast features: Jie Chen, MD, MS, Vice President of CMC Management, WuXi Biologics The success of therapeutic biologics over the past decades has reshaped the pharmaceutical industry landscape. From orphan to biosimilar to novel blockbuster drugs, the production demands can range from grams to metric tons of biopharmaceutical products each year. This diverse range in manufacturing scale coupled with thousands of biologics in the development pipeline, has had significant impact on the design of biologics production models. Without…

A Novel Approach to Single-Use Design and Implementation

by BPI Contributor

This webcast features: Graeme Proctor, Product Manager, Single Use Technologies, Parker Hannifin Manufacturing Ltd Single use assemblies can frequently take in excess of 16 weeks from concept to customer delivery. Challenges around design, customisation, validation and qualification can create delays in implementation and increase time to market. Parker will present a novel approach to single use design and implementation, which can dramatically reduce lead times and increase delivery reliability without affecting flexibility or quality. Learn how to: Quickly and easily…