Manufacturing

Improving CHO Cell Biomanufacturing via Whole Genome CRISPR Screening

This webcast features: Jamie Freeman, PhD, Product Manager, Horizon Discovery While Horizon’s GS knockout CHO K1 cell line is rapidly becoming established as one of the best performing cell lines available for the manufacture of biotherapeutics, there is untapped potential within the CHO system. Horizon is focused on using its expertise in genome engineering techniques to modify CHO cell lines to improve their expression capacity for biomanufacturing. Historically, efforts to increase yield have primarily focused on improving media and feed,…

Use of Systematic Tools to Expedite Process Characterization and Maximize Reliability of Process Validation Campaigns

This webcast features: Abel Hastings, Director of Process Sciences, Fujifilm Diosynth Biotechnologies During this webcast you will learn how using a suite of tools, standard practice, and depth of experience in PPQ readiness are aimed at: Effectively focusing attention on critical process understanding and control Scoping and completing the ideal scope and range of characterization Studies to support reliable operations in manufacturing Maximizing reliability during PPQ and commercial manufacturing Enabling full preparedness for PAI and regulatory review   Just fill…

Key Considerations for Advanced Therapies Manufacturing

This webcast features: Thomas Page, PhD, Vice President, Engineering and Asset Development, Fujifilm Diosynth Biotechnologies This technical webinar covers key considerations to support manufacturing activities from the earliest stages of cell line, viral replication platforms and/or viral vectors identification stage leading into clinical production. Having a line of sight into commercial production and the requirements leading into commercial approval are also essential for success. Key messages: Flexibility in conjunction with high containment are key for success Application of closed systems…

Validation of the MycoSeq Mycoplasma Detection Kit for the Release of Veterinary Products

This webcast features: Sébastien Lievyns, Scientist, and Dr. Anne Thomas, Senior Principal Scientist, Analytical Sciences, Zoetis This webcast aims to show how Zoetis has validated the MycoSeq kit for the release of animal products. The Analytical Sciences group at Zoetis confirmed the limit of detection at 10 CFU/mL and good repeatability and intermediate precision of the qualitative mycoplasma qrt-PCR method in presence of these products. For direct PCR performed on vaccine, a background amplification is sometimes observed inducing a signal…

Setting Up a Rapid Mycoplasma Assay Supporting Recombinant Production

This webcast features: Kent Persson, PhD, Project Manager, Octapharma Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant human FVIII produced in human cells. Regulatory guidelines states that recombinant bulk harvest need to be tested for mycoplasma prior to further processing. The presentation will give the overview on a nearly completed journey on replacing an out-sourced mycoplasma test with Thermo Fisher’s MycoSEQ qPCR assay. Octapharma in Stockholm has recently been sought regulatory approval for the…

Advantages of Fluoropolymer Single-Use Systems

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…

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

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…

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…

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…