Ask the Experts

Shortening Timelines and Reducing Headaches by Developing a Clinical Trial Strategy Earlier During Drug Development

This webcast features: Kristen DeVito, Global Director, Clinical Supply Services, Catalent Pharma Solutions Biologic clinical trials can be complex with many factors to consider.  Understanding your specific needs and developing a plan early on during drug development can reduce delays and missteps during clinical trials.  This presentation will discuss: How protocol design can impact clinical supply strategy Which clinical supply variables are most likely to be on the critical path Proactive steps to ensure continuity of supply and reduce the…

Don’t Just Pass the Baton: Comprehensive Capabilities and Parallel Processes Accelerate Biologic Development Timelines

Biologic drug development from DNA to commercialization involves many moving parts, which can be difficult for companies to coordinate. For example, there are often new expert stakeholders introduced during each stage of development, leading to inefficiencies and confusion. However, with deep expertise and effective communication between teams, companies can reduce risk and shorten time to clinic and, subsequently, to market. In this webinar series, three biologics subject matter experts will discuss critical considerations in their respective areas of expertise: drug…

Ask the Expert: Preparing for and Managing Regulatory Inspections

An “Ask the Expert” webinar on 27 November 2018 featured Ray Marzouk, vice president of quality at Avid Bioservices, a biologics contract development and manufacturing organization (CDMO) in Orange County, CA. With six successful preapproval inspections behind it, Avid prides itself on a 13-year industry-leading regulatory track record. Marzouk’s Presentation Preparing for the Inspection: Implement a standard operating procedure (SOP) for inspections that includes instructions for the receptionist, host, scribe, subject matter experts (SMEs), and document finders. Prepare SMEs for…

Ask the Expert: Custom Media Services: Bioproduction Media Optimization Through Spent-Media Analysis

On 29 November 2018, Matthew Smonskey (senior scientist in the Gibco Custom Media Services team at Thermo Fisher Scientific) presented an “Ask the Expert” webinar on resources available to help developers identify media limitations and options for designing custom media formulations that maximize protein yield. Smonskey’s Presentation  Gibco’s goal is to solve its clients’ bioproduction problems: e.g., creating a chemically defined medium, increasing end-point titer, modifying protein quality attributes, and so on. Designing custom media using spent-media analysis might solve…

Ask the Expert: A Modular Chromatography Platform with a Lattice-Supported Bed

In an Ask-the-Expert webinar on 4 December 2018, Jason Chiu (product marketing scientist at JSR Life Sciences) introduced the Chromassette chromatography cassette platform. This stackable, modular technology and resin-support device presents a productive and disposable process that can scale to any volume using any resin. An internal scaffold provides a uniquely supported resin bed, and the system is fully interchangeable with conventional column formats. Chiu’s Presentation The Chromassette platform offers linear scalability, superior pressure-flow properties, high-productivity separations, and rapid and…

Enabling Success in Biologic Drug Substance Development and Biomanufacturing by Leveraging Expertise and Collaboration

This webcast features: Steven Perry, PE, Senior Director of Manufacturing Sciences, Catalent Biologics Biologic drug substance development and biomanufacturing is a critical step in the long, complex pathway to approval. There are many considerations to be made around cell line and process development, analytical testing and late stage activities such as process characterization and validation. This presentation discusses: Critical drug substance resource needs of sponsor companies How expertise and collaboration amongst the key stakeholders enables successful development and scale up…

Current Analytical Approaches to Biophysical Characterization in a Regulatory Environment

This webcast features: Dr. Anshuman Shukla is Intertek’s Biophysical Characterisation expert at the Center of Excellence for Biopharmaceuticals in Manchester, UK. Structural integrity of protein based therapeutics is one of the major challenges in the biopharmaceutical industry where multiple factors such as the stability, efficacy and shelf life could be affected following minor changes in manufacturing process. This becomes critical particularly with development of more and more biosimilars where comparability to a reference product is required to ensure that the…

Introducing Chromassette: Modular Chromatography Platform with a Lattice Supported Bed

This webcast features: Jason Chiu, Product Marketing Scientist, Bioprocess Group, JSR Life Sciences. Chromassette®, a lattice-supporting modular chromatography device, eliminates the constraints of modern column chromatography. The Chromassette technology offers the separation capabilities of conventional chromatography plus the convenience, scalability and other benefits of a pre-packed cassette through its unique, internal scaffold structure that provides consistent “wall support” to all resin beads. In this webinar we will discuss how Chromassette enables high flow-rates for any type of resin regardless of…

Bioproduction Media Optimization Through Spent Media Analysis

This webcast features: Matthew Smonskey, R&D Scientist, Gibco Bioproduction Services Group, Thermo Fisher Scientific Individual cell lines have unique nutritional requirements which may not be satisfied using catalog media. These deficiencies often result in less than optimal recombinant protein yields during a bioproduction process. This presentation will discuss resources available to identify these media limitations and options for designing custom media formulations in order to maximize protein yields. Just fill out this form to watch the recorded webcast now.

High Productivity Harvest – Intensify Harvest and Displace Depth Filtration in Fed Batch Cell Culture

This webcast features: John Bonham-Carter, Director of Upstream Sales, Repligen High Productivity Harvest (HPH) is a novel application developed by Repligen that enables you to harvest a fed batch bioreactor in a fully sterile manner while eliminating both centrifugation and depth filtration. A 0.2µm filtered, closed system and single step process using the XCell™ ATF System, HPH can significantly increase yields above industry standards and generate a sterile clarified batch harvest ready for either batch or continuous chromatography. This webinar…