Ask the Experts

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

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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…

October 20, 2017

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

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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…

October 18, 2017

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

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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:…

October 18, 2017

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

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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…

October 18, 2017

Single-Use Bag Permeability Testing in Cryopreservation Conditions

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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…

October 9, 2017

Purification of Antibody Fragments with Amsphere™ A3 Protein A Resin

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This webcast features: Gerald Platteau, Application Development Engineer, JSR Life sciences Purification of full-length antibodies containing an Fc region relies on Protein A affinity chromatography as the golden standard capture step. The well-known robustness, high selectivity and scalability make it an ideal platform technique, minimizing downstream processing development time to bring new antibodies to market. After monoclonal antibodies (mAbs), various forms of antibody fragments are now becoming the next most important class of protein based therapeutics. These antibody fragments offer…

September 14, 2017

CHT Column Packing is Easier
Than You Think

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This webcast features: Dr. Mark Snyder, Manager, R&D Applications, Process Chromatography, Bio-Rad Laboratories This webcast presents best practices and guidelines for packing CHT™ Ceramic Hydroxyapatite Media at process scale. CHT, is an easy-to-use mixed-mode chromatography media. It offers cation exchange and affinity interactions. Unlike other chromatography media, CHT is both the ligand and the support matrix. It is used for the purification of numerous types of biomolecules and is considered the gold standard for aggregate removal. This webcast highlight CHT…

September 7, 2017

Single-Use Powder Containment Solution

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This webcast features: David Howes, ILC Dover Learn about modern single-use powder containment best practices and how to reduce cross contamination and airborne particulates.   You will gain insight on how you can increase safety and speed when handling powders.  In the study, we will discuss the ease of fill along with dispensing times and product loss. ILC Dover’s EZBiopac® shows a 71% decrease in filling times when measured against an industry standard 2D bag. Due to the non-static film we…

August 30, 2017

Proper Task Performance in GMP BioManufacturing: Human Error Reductions

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This webcast features: Tony Fultz, Director of Upstream Manufacturing at Fujifilm Diosynth Biotechnologies. Human error reduction should be a top priority of every organization. Our company, clients, and most importantly, our patients are heavily dependent on right first time execution. Human error is, and will likely always be, the highest contributor to deviations and batch failures. Fujifilm Diosynth Biotechnology (FDB) is aggressively seeking to reduce human error. Using his experience in the nuclear industry, Tony Fultz shares a method implemented…

August 28, 2017

Routinely Identify Low-Level Attributes – Fast and Accurately

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This webcast features: Sibylle Heidelberger, Technical Marketing Manager for Biologics, SCIEX. Biotherapeutic peptide mapping LC-MS acquisition methods can make it difficult to routinely identify low-level modifications, such as deamidation and oxidation. This webinar discusses how the use of generic SWATH® Acquisition method on the benchtop X500B QTOF System and BioPharmaView™ Software allows you to confirm the identity of low-level attributes with fast and accurate batch analysis and processing. She also presents how the use of this unbiased data-independent SWATH® Acquisition…

July 20, 2017