Manufacturing

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…

Collaborate to Innovate: A Webinar Series

As a senior leader in pharmaceutical development and manufacturing, you know that keeping up-to-date on industry trends is critical to maintaining competitive edge. But do you know how to actively drive these trends and apply them to your manufacturing processes? Are you collaborating with the right stakeholders in order to expand your capabilities and bring your innovation strategy to life? In this webinar series, three subject matter experts will share their perspective on the future of the industry and provide…

Accelerating the Biotech Value Chain Through the Implementation of High-Throughput Technologies

This webcast features: Fredrik Nilsson, Director of Downstream Development, and Jesper Worm, PhD, Scientist, Department of Analytical Development, at CMC Biologics. In this webinar, the speakers discuss and analyze the use of high-throughput technologies to optimize timelines and deliver value within the upstream and downstream development processes, using Octet HTX platform technology. Over the past year, the experts at CMC Biologics have used this technology to deliver a significant number of titer data points, and residual protein data measurements. This…