Manufacturing

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…

Single-Use Powder Containment Solution

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…

Proper Task Performance in GMP BioManufacturing: Human Error Reductions

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…

Routinely Identify Low-Level Attributes – Fast and Accurately

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…