An Extractable and Leachable Program for Assessing Single-Use Components and Systems

This webcast features: Chris Shields, Director of Global Product Validation Services at Saint-Gobain Life Sciences. Extractable testing is traditionally performed by single-use suppliers, and while not required by industry regulations, it is the drug manufacturer’s expectation that this information form part of a product’s data package. Extractable and leachable testing is designed to determine the chemical compounds that may migrate into the customer’s fluid from the single-use product’s fluid contact layer. Extractable testing utilizes aggressive but relevant test conditions, while…

Development of a Novel Thermoplastic Tubing, FP-FLEX and Single-Use Freezing Bag for Working Cell Banks Enabling Closed-System Processing to Temperatures as Low as -196 °C

This webcast features: Dominic Clarke, Global Product Manager, Charter Medical Working cell banks (WCB’s) are commonly applied to initiate cell culture manufacturing campaigns for production of recombinant or therapeutic proteins. These campaigns typically begin with inoculation of cells previously cryopreserved in cryovials.  While cryovials are typically used in the development of WCB’s and initiation of manufacturing campaigns, they are not optimal for the growing demands of commercial production. Cryovials are small and filling/removal is performed through an open screw cap. This…

Secondary Packaging: Creating Value with Product Lifecycle Management

This webcast features: Daniela Guttmann, Product and Service Manager at Vetter, and Susanne Hall, Team Leader of Secondary Packaging at Vetter. Factors such as new regulatory requirements (e.g. serialization) and expenses associated with secondary packaging have created significant interest in Product Lifecycle Management (PLM). When incorporated early in the planning process, PLM can boost a product’s chance for success by helping to meet market requirements, and save costs. Watch the webcast on PLM for Secondary Packaging, and learn how it…

2D DIGE Western Blot for HCP Detection and Coverage Determination: Advantages of Fluorescence over Colorimetric Detection

This webcast features: Jamina Fiedler, Head of 2D Analytics at BioGenes GmbH. Biopharmaceutical products need to be free of contaminating host cell proteins (HCPs) prior to approval and regulatory bodies ask for a clear and manifest proof that HCP assays are fit for purpose. The colorimetric 2D Western Blot method, although widely used for HCP detection and coverage determination, has several limitations. Using examples, webinar participants will learn how the use of fluorescent dyes can help overcome these limitations to…

Dual-Chamber Syringes vs. Vials

Is there a clear choice between dual-chamber syringes and vials in today’s competitive drug development market? That’s the topic of this recorded webcast. During the webcast, the speakers address the following questions: What are the causative factors that have resulted in the rapid increase in prefilled syringes over the last several years? Do dual-chamber syringes offer distinct advantages over vials in drug development? How can dual-chamber technology help differentiate products in a highly competitive environment? What are the main differences…

Clinical Syringe Development Webinar

Clinical Syringe Development: An Innovative Approach to Gain an Early Advantage

Do ever-rising drug development costs, highly competitive markets, and increasing regulatory demands sound familiar? This webcast addresses the benefits of starting syringe work earlier in the development process of injectables. This webcast will: Provide an overview of the many development challenges faced by pharmaceutical and biotechnology companies Discuss the benefits of clinical syringe development including time savings and package attractiveness Offer a case study with a live question and answer session Feature thought leaders Dr. David Brett and Dr. Sabine…

Driving Optimal Cell-Level “Observability” and Data-Driven Process “Guidance”

In the spirit of implementing PAT (Process Analytical Technology), biopharmaceutical companies are striving to gain a more fundamental understanding of what is happening to the cells within their bioreactors. Implementation of online tools like Raman and Dielectric Spectroscopy are helping to provide insight, yet there is still a gap integrating this data with off-line measurements such as cell density, viability, metabolite levels and titer. Bend Research, in collaboration with major biopharmaceutical companies, is working to advance MAST, a modular, automated sampling platform that can provide samples directly from bioreactors to analytical devices, while maintaining process sterility. In this webcast, Clint Pepper, Ph.D. and Lisa Graham Ph.D., P.E. of Bend Research focus on this overall cell-level “observability” concept and illustrate how the MAST platform is incorporated.

Small Scale Automated Vial Filling

For small scale vial filling operations the FLT features an ideal platform. With the ability to automatically fill, stopper, and cap most common vials with minimal size parts and a user friendly control system the FLT has the features big machine features in a compact package. The mobile cart and standard utility requirements the FLT can be utilized by several different users in a lab situation. The FLT can be used with a peristaltic pump, or a rolling diaphragm dosing system, both of which are available as a single use option from the Bosch PreVAS dosing system family. Utilizing an automated system reduces filling error and product loss in comparison to manual filling operations, reduced operator fatigue and improved productivity without adding headcount.

Intensified Manufacturing: Economic Models Comparing Steel, Single-Use and Concentrated Process Options

Refine Technology, LLC, in conjunction with Biopharm Services, developed two economic models to examine the cost of goods and capital requirements of cell culture production facilities configured based on different production scenarios, including variables such as:

• Amount of product required
• Vessel sizes
• Number and type of vessels (stainless steel vs. single use)
• Product titer
• Seed train
• Upstream and downstream requirements

In this educational webcast, John Bonham-Carter, Vice President of Sales and Business Development at Refine Technology, analyzes the effect of these variables in relation to operating mode, continuous culture (perfusion) versus traditional fed batch. Join John as he presents results and discussion for facilities producing 50 and 500Kg of protein per year.

Blank Slate Biomanufacturing: Designing the Ideal Operation from a Blank Sheet of Paper

If you could start with a blank sheet of paper, what would your biomanufacturing operation look like? Robust, adaptable, cost-effective and efficient probably come to mind, but how do you get there? In this educational webcast, Parrish Galliher, Founder and CTO of Xcellerex, takes an in-depth look at the strategies involved in designing the ideal biomanufacturing facility from a blank slate. You’ll learn how to optimize your operation to:

• Increase Speed
• Enhance Flexibility
• Decrease Risk
• Improve Economics

View this webcast to discover the steps for maximizing your biomanufacturing process.