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…
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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…
Trends in Real-World Study Design and Postmarketing Commitments in the EU and US: What We Can Learn from Big Data
When a new medicine is approved, there is under a 25% chance that the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA) will impose, as part of conditional approval, studies conducted to satisfy postmarketing requirements. US regulations governing such studies are found in the 2011 guidance document regarding “Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (1).†EMA regulations are found in the 2017 “Guideline…
Integrated Solutions for Biologics Formulation and Drug Product Development
This webcast features: Dr. Yunsong (Frank) Li, Director of Process Development, Catalent Biologics There are many challenges to conduct thorough drug product formulation development at early stage drug substance process development. Those challenges include material limitation, suitable analytical method, time and labor cost. Sufficient development of the right formulation and dosage form for biologics products early on helps to avoid formulation redevelopment and change during the later stage of product development, which leads to additional analytical, pharmacokinetics or even clinical…
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…
Speeding Characterization of Biologics: Replace Traditional Assay Technologies with Label-Free Quantification and Kinetics
FortéBio’s Octet instruments are an ideal replacement for ELISA, HPLC, and SPR techniques in quantification of antibodies and recombinant proteins and in testing product potency for lot release. Bio-Layer Interferometry (BLI) technology monitors biomolecular interactions in real time to determine affinity, kinetics, and concentration. The plate-based, microfluidics-free format offers users several distinct advantages over other technologies. BLI-based systems can achieve higher throughput, with the flexibility to measure two to 96 samples simultaneously. Lower maintenance requirements and increased ease-of-use further shorten…
Ask the Expert November: Expediting Characterization and Maximizing Reliability of Process Validation
On 24 October 2018, BPI presented a free “Ask the Expert†webinar with Abel Hastings, director of process sciences at Fujifilm Diosynth Biotechologies. He discussed the use of systematic tools to expedite process characterization and maximize reliability of process validation campaigns. Hastings’s Presentation As a project moves from clinical manufacturing toward process validation — and ultimately toward preapproval inspections — project timelines can become hypervisible at all levels of an organization. Missteps can be costly. The commercial viability of a…
Ask the Expert November: Improving CHO-Cell Biomanufacturing with a Whole-Genome CRISPR Screening
On 18 October 2018, BPI presented a free “Ask the Expert†webinar with Jamie Freeman, a bioproduction product manager at Horizon Discovery. His company is developing a whole-genome screen using clustered regularly interspaced short palindromic repeats (CRISPR) for improving the capacity of Chinese hamster ovary (CHO) cells in biomanufacturing. Freeman’s Presentation Freeman described the screening approach that Horizon developed to improve its own CHO cells. It also may be used to improve other such cell lines for biomanufacturing. Founded 11…
Ask the Expert November: New High-Performance AEX Resin for Purification of Large Biomolecules
On 20 September 2018, Jiali Liao (principal scientist in process chromatography R&D at Bio-Rad Laboratories) led a BPI “Ask the Expert†webinar introducing the high-performance, high-capacity Nuvia HP-Q Anion Exchange Resin, which can be used for purifying large biomolecules. Liao’s Presentation Purifying large biomolecules — e.g., plasma proteins, immunoglobulins, viruses, virus-like particles (VLPs), and PEGylated proteins — can be difficult. Their size makes for slow diffusion through the pores of traditional chromatography resins and poor mass-transfer kinetics, which decreases binding…