Ask the Experts

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…

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…

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…

Webcast: Accelerating Vaccine Production with Non-Viral Cell Engineering

This webcast features: Victor Ayala, PhD, ABL Inc. Protein expression for manufacturing falls into one of two basic categories: stable cell line generation or transient transfection. While stable cell lines provide consistency in product quality and quantity, they are also expensive and time-consuming especially in early discovery and development phases. In this webinar, a fully-scalable cell engineering technology employing a transient transfection strategy will be discussed. This technology has allowed for the efficient and cost-effective evaluation of vaccine candidates in…

Improving CHO Cell Biomanufacturing via Whole Genome CRISPR Screening

This webcast features: Jamie Freeman, PhD, Product Manager, Horizon Discovery While Horizon’s GS knockout CHO K1 cell line is rapidly becoming established as one of the best performing cell lines available for the manufacture of biotherapeutics, there is untapped potential within the CHO system. Horizon is focused on using its expertise in genome engineering techniques to modify CHO cell lines to improve their expression capacity for biomanufacturing. Historically, efforts to increase yield have primarily focused on improving media and feed,…

Ask the Expert on Ceramic Hydroxyapatite Chromatography Media: How to Start

Bio-Rad’s CHT Ceramic Hydroxyapatite XT (CHT XT) calcium-affinity cation-exchange chromatography medium is used for purifying numerous types of biomolecules, with single-step clearance of impurities and aggregates in monoclonal antibody (MAb) purification. This is an easy-to-use mixed-mode medium, which is both ligand and support matrix in one. In an “Ask the Expert” webinar on 18 July 2018, Mark Snyder (manager of the process chromatography R&D applications group at Bio-Rad Laboratories) discussed its application and use at process scale, providing guidelines on…

Ask the Expert: Key Considerations for Advanced Therapies Manufacturing

On 12 September 2018, Thomas Page, PhD (vice president of engineering and asset development at Fujifilm Diosynth Biotechnologies, FDB) shared a brief overview of challenges encountered in manufacturing of advanced biotherapeutics. Page’s Presentation FDB is a contract and development manufacturing organization (CDMO) that uses microbial and mammalian cell lines to produce protein therapeutics as well as viral vaccines and gene therapies. The company’s Center of Excellence for Advance Therapies Manufacturing is located in Texas. FDB set out some years ago…