Ask the Experts

A New AEX Mixed-Mode Chromatography Resin for High Selectivity and Recovery

This webcast features: Dr. Xuemei He, R&D Manager, Chromatography Media Chemistry, Bio-Rad Laboratories Biomolecules are becoming more diversified and complex. Bio-Rad’s newest hydrophobic AEX chromatography resin, Nuvia aPrime 4A, is engineered with distinct balance of ligand density and hydrophobicity. In this webinar, Dr. Xuemei He will introduce the properties of Nuvia aPrime 4A Resin. This mixed-mode resin is designed to facilitate selective and reversible binding of target molecules for higher purity and recovery over traditional chromatography resins. Case studies will…

The Proper Use of Extractables Data: Aspects Beyond Extractables Measurement

This webcast features: Dr. Armin Hauk, Lead Scientist, and Jean-Marc Cappia, Head of Segment Marketing Vaccines, at Sartorius Stedim Biotech The implementation and use of single-use system (SUS) in biopharmaceutical production is rapidly increasing and directly correlated with higher demands on Extractables and Leachables (E&L) information. Sartorius as a leader in SUS technology can look back on +20 years of experiences in the E&L area. This knowledge together with our current research initiatives enables us to progress and go beyond…

Ask the Expert: Acoustic Cell Processing

As cell and gene therapies approach commercialization, the industry is looking for scalable manufacturing solutions. Equipment providers need to design specifically for the good manufacturing practice (GMP) environment and the unique needs of cell and gene processing. On 3 April 2019, Kevin Lannon of FloDesign Sonics presented an “Ask the Expert” on one company’s solution. LANNON’S PRESENTATION In a typical cell therapy manufacturing process, steps that require washing, concentration, or buffer exchange include centrifugation, filtration, and counterflow filtration. Each has…

Automating Workflow Solutions, Not Instruments: Engineering Validated Processes for Biologics Screening

This webcast features: Brian Bordeau, Business Development, Global Advanced Workflows and Engineered Solutions Automation can be a lifeline for scientists working in the discovery and development of biologics. The prospects for increasing sample throughput, reducing operator time, and streamlining data audit trails are alluring. However, at the same time, introducing automation can be a frightening and confusing project, with efforts often falling short of expectations for lack of bigger picture thinking. The Advanced Workflow Engineering Solutions (AWES) team at Molecular…

China Biopharma Opportunities

This webcast features: Michael Frizberg, President, CMAB – Switzerland and Hong Kong and Eric Langer, Principal, BioPlan Associates China aspires to become one of if not the leading country contributor to the global pharmaceutical and biopharmaceutical industry by 2030. Large companies in this sector—both international firms expanding their own footprint within China and indigenous Chinese firms establishing both their internal and their global footprints—have witnessed double-digit growth for much of the past five to seven years. The global pharmaceutical and…

Clearing the Way for Viral Clearance

This webcast features: David Cetlin, CEO, MockV Solutions and John Li, Staff Scientist, Thermo Fisher Scientific. To determine the viral clearance efficacy of biomanufacturing steps, mammalian viruses are “spiked” into in-process solutions, processed and analysed for reduction. Due to the infectious nature of these live viruses, “spiking studies” are typically conducted in specialized BSL-2 facilities. The costs and logistics associated limit viral clearance analysis during process development and characterization. To overcome this challenge, a non-infectious Minute Virus of Mice –…

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…