Ask the Experts

Planova BioEX: Leading the Next Generation of Virus Filters

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

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

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

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

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…

Targeted Locus Amplification for Transgene Sequencing in rCHO Clones Expressing Therapeutic Lysosomal Enzyme

This webcast features: Vishal Agrawal, PhD, Scientist II, Cell and Molecular Biology, Biomarin Pharmaceutical Inc. and Joseph Abad, Field Applications Scientist, MaxCyte. Transgene site of integration dictates clonal stability and the long term transcriptional activity of gene of interest in recombinant CHO cells. In this presentation, we will discuss the application of targeted locus amplification (TLA) technology to identify genomic sites of transgene integration and integrity of transgene sequence itself to assess the suitability of recombinant CHO clones as a…

Ask the Expert for Better Single-Use Powder Containment for Media and Buffers

Dave Howes (senior applications specialist at ILC Dover) introduces his company’s market-leading solution for single-use powder containment. Howes’s Presentation Some challenges in biopharmaceutical powder manufacturing include optimizing open-suite facilities; minimizing product loss from spills; lessening waste and cross-contamination; reducing worker exposure to airborne particulates; and lowering the risk of ignition with flammable materials. Characteristics to look for in a powder-transfer system are a system design that is exclusively meant for powders (not adapted from liquid-transfer designs) large-diameter top openings for…

Ask the Expert: Human-Error Reductions — Proper Task Performance in GMP Biomanufacturing

Tony Fultz (director of upstream manufacturing at Fujifilm Diosynth Biotechnologies) presented an “Ask the Expert” webinar on 23 August 2017. Fultz’s Presentation Human error was responsible for about 75% of batch failures at contract manufacturing organization Fujifilm Diosynth Biotechnologies in 2016. Technicians operate in a dynamic and stressful environment, both contributing factors to human error. With multiple projects running concurrently, some employees are involved in executing several processes during a shift. The company has several ways of reducing human error:…

Ask the Expert: CHT Column Packing Is Easier Than You Think

On 6 September 2017, Mark Snyder (manager of the process chromatography R&D applications group at Bio-Rad Laboratories) gave an “Ask the Expert” presentation on process-scale column packing with CHT ceramic hydroxyapatite media. Snyder’s Presentation CHT is an incompressible mixed-mode chromatography medium using cation exchange and calcium-affinity interactions, and it is available in 40-μm and 80-μm particle sizes. This medium can be used to purify monoclonal, polyclonal, and bispecific antibodies; antibody fragments; other recombinant proteins and isozymes; viruses, viral particles, and…

Single-Use Bag Permeability Testing in Cryopreservation Conditions

This webcast features: Mike Johnson, Business Development Engineering Manager, Life Sciences Puncture strength, haze, Tg, extracts and permeation rates are all single-use bag attributes about which end-users want data. While these are important characteristics, they are polymeric material properties that may or may not indicate actual bag performance. Ultimately, an end-user wants to know that the single-use bag will not put their process fluid at risk. In this study, single-use bags with different gas permeation rates were filled with a…