Webcasts

Predicting Viral Clearance: DOE, HTS, and AAV Case Studies Using a Non-Infectious MVM Surrogate in Downstream Development

Non-infectious mock virus particles that mimic the physicochemical properties of live infectious viruses can be used as spiking agents during viral clearance testing. Review results from several studies using an economical spiking surrogate—a non-infectious minute virus of mice-mock virus particle (MVM-MVP)—to demonstrate viral clearance in industrial processes. Tuesday, Oct 6, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after final airing until Oct. 6, 2021.

Risk Mitigation for Single-Use Cold Chain Distribution

The cold chain distribution of biopharmaceutical products is hampered by product loss from brittle components and temperature excursions. Learn about a risk-mitigation strategy and study results that highlight the importance of choosing the right low-temperature materials, use sensors for monitoring the distribution process step, and testing to qualify a single-use cold chain solution. Monday, Oct. 12, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after final airing until Oct. 12, 2021.

Media Selection Made Easy:  Selecting the Best Media for Your Aseptic Process Simulation

Media fill tests ensure the safe production of parenteral drugs. Learn factors to consider when selecting media for aseptic process simulations including US and European regulatory requirements and eser requirement specifications for equipment and instruments. Tuesday Sept. 29, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Sept. 29, 2021.

Process Analytical Technology (PAT): Online Monitoring and Control of Upstream Titer, Product Quality and Amino Acid Content Using 2D-LC with SegFlow Interface

Biopharmaceutical companies are transitioning from “quality-by-testing” philosophy to “quality-by-design” paradigms, and establishing QbD-based PAT tools to increase product and process understanding. Due to the deficit of analytical methods to support QbD-driven continuous bioprocessing, biopharmaceutical companies are actively developing PAT tools to comply with QbD regulations. Europe Broadcast: Wednesday, Sept. 30, 2020 at 9am EDT | 2pm BST | 3pm CEST US Broadcast: Wednesday, Sept. 30, 2020 at 2pm EDT | 1pm CDT | 11am PDT On demand available after final airing until Sept. 30, 2021.

A New Approach for Glycosylation of Therapeutic Proteins

Variation in glycosylation can impact the safety and efficacy profiles of a therapeutic protein. Join Dr. Hua Tu from LakePharma to learn about achieving greater control of glycosylation while allowing maximum protein expression. Wednesday, Sept. 16, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after final airing until Sept. 16, 2021.

Advancing N-Glycan Analysis of Next Generation Biotherapeutics with Optimized Protocols and Easy Automation

Adopting automation technology to gain efficiency for biopharmaceutical assays can be daunting. Learn how a modern approach to laboratory robotics can make implementing sample preparation automation easier than ever. Tuesday, Sept. 15, 2020 at 9am EDT | 2pm BST | 3pm CEST On demand available after final airing until Sept. 15, 2021 Tuesday, Sept. 15, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Sept. 15, 2021.

The increase in non-monoclonal antibody protein drug candidates has required researchers to develop new methods. By adapting existing approaches find out how Dr. Stephen Lock is answering this challenge to better profile these extremely complex proteins. Wednesday, Sept. 2, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Sept. 2, 2021.

This event will aim to present an overview of how analytical technologies can be adapted for implementation of Process Analytical Technology (PAT) in bioprocessing and how this can result in effective process control, thereby delivering consistent process performance and product quality. Live: Europe Broadcast: Thursday, Jul. 30, 2020 at 9am EDT| 2pm BST| 3pm CEST US Broadcast: Thursday, Jul. 30, 2020 at 2pm EDT| 1pm CDT| 11am PDT On demand available after final airing until Jul. 30, 2021

Existing biopharma supply chain practices must evolve to meet the needs of personalized therapies, particularly for autologous treatments. Force fitting manual processes will no longer work. Hear about lessons learned in a pioneering “vein to vein” pilot program that aims to establish new rules for data management and exchange, scheduling, and automating workflow and supply chain practices for novel and complex processes. Live: Wednesday, Jul. 29, 2020, at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On Demand: available after airing until Jul. 29, 2021 Register free

The complexities of producing cell therapies and gene therapies are testing established biomanufacturing practices and the companies engaged in producing the treatment. Join this webcast to hear about the technical and regulatory hurdles associated with development and manufacturing steps, and strategies and solutions to facilitate development through commercialization. Live: Tuesday, Jul. 28, 2020, at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On Demand: available after airing until Jul. 28, 2021 Register free

The discovery of nitrosamine-based impurities in APIs has triggered recalls of commonly used drugs and placed the quality of the drug supply in question. Learn best practices for identifying impurities in drug substances and drug products and the roles and responsibilities of ingredients suppliers, drug manufacturers, and regulatory authorities. Live:Tuesday, Jul. 14, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On Demand: available after airing until Jul. 14, 2021 Register free

An automated multi-attribute method (MAM) approach providing high-throughput, user-friendly analysis of process validation samples is moving mass spectrometry toward biopharma quality control. Learn how to implement automated MAM approaches for process development and validation and streamline approaches using a single scalable enterprise software platform. Live: Tuesday, Jun. 30, 2020 at 10am EDT | 9am CDT | 2pm BST | 3pm CEST On demand available after final airing Jun. 30, 2021 Register free

How can you better identify those host cell proteins (HCPs) that might co-purify with your drug substance (DS) and elicit an undesired immune response, interfere with drug safety and efficacy, or impact DS stability? Cygnus Technologies VP of R&D, Eric Bishop, will discuss powerful orthogonal methods such as immunoaffinity chromatography and mass spectrometry that enable full understanding of those HCPs that are present in the product and could potentially impact patient safety and drug stability. Live: Tuesday, Jun. 16, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after airing until Jun. 16, 2021 Register free

For any quantitative HPLC experiment, the accurate preparation of verified standards is necessary and reliant on accurate weighing procedures. Learn about practices to ensure accurate measurements in quality control laboratories. Live: Thursday, May 28, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after airing until May 28, 2021 Register free

Fast growth in cell and gene therapy industry has generated an urgent need for fast and robust analytics for characterization and impurity determination for viral vectors. Mass spectrometry (MS) and capillary electrophoresis (CE) open up new avenues to enable fast and actionable analytics to enable quicker development and commercialization of gene therapies. Live: Wednesday, May 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until May 27, 2021

Learn how to achieve better resolution, reproducibility, and quality data for intact mAb and sub-unit analysis. In this webcast, Brian Rivera will review method optimization for a new wide pore C4 core-shell particle that further exhibits improved efficiency and robust separation for large molecules. Live: Thursday, May 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing May 21, 2021 Register free

Join Ankita Desai from Eppendorf and Arie Reijerkerk from Ncardia in this webcast and Q&A session to learn about the benefits of stirred-tank bioreactors for the drug discovery and development process. Get insights about how the advent of human-induced pluripotent stem cell (hiPSC) technology has substantially expanded the availability of human cells. On demand available until May 21, 2021 Register free

This PharmaTalks session focuses on how the integration of Patheon into Thermo Fisher Scientific has resulted in unique opportunities for innovation, collaboration, and technology development, and how we are leveraging the Thermo Fisher ecosystem to develop and improve a platform for biopharmaceutical manufacturing Available On Demand Register free

Are you seeing the whole picture with your current analysis tools? Join us to learn how low volume, high throughput particle analysis with BMI provides more information and faster insights at any stage of biologic development – even at high concentrations. Live: Tuesday, May 12, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until May 12, 2021 Register free

Join us for a free webcast on April 29th to learn about the advantages of using high-performance LC-MS and how you can obtain quality results. In this webcast will cover the latest developments in the use of high-performance LC-MS for biopharmaceutical analysis, including transitioning product characterization knowledge into monitoring assays for product and process related quality attributes of biopharmaceuticals. Live: Tuesday, April 14, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until April 14, 2021

The global coronavirus pandemic has tested the abilities of bio/pharmaceutical companies to develop new therapies and maintain-or even accelerate-production of existing drugs. In this webcast, experts will discuss business continuity practices, regulatory compliance, and supply chain management under current-or future-emergency conditions. Live: Tuesday, Apr. 28, 2020 at 11 am EDT | 10 am CDT | 8 am PDT On Demand: available after airing until Apr. 28, 2021 Register free

This webcast discusses a highly sensitive and automated workflow for intact biotherapeutic characterization and quantitation from biological matrices. We will also discuss native protein characterization and its challenges. Europe Broadcast: Thursday, Apr. 23, 2020 at 9am EDT | 2pm BST | 3pm CEST US Broadcast: Thursday, Apr. 23, 2020 at 2pm EDT | 1pm CDT | 11am PDT On demand available after final airing until Apr. 23, 2021

Working with glycosylated therapeutics? Join Aled Jones and David Wong for a discussion of multi-level LC/FLD/MS quantitation workflows for N-glycan analysis of biotherapeutics, including intact mass, subunit, glycopeptide, released glycan, and sialic acid monosaccharide analysis. Tune in to learn about how these options can help you. Live: Europe & US Broadcast: Tuesday, Mar. 31, 2020 at 9am EDT | 2pm BST |3pm CEST US Broadcast: Tuesday, Mar. 31, 2020 at 2pm EDT | 1pm CDT | 11am PDT Asia Pacific: Wednesday, Apr. 1, 2020 at 8:30am IST | 12pm JST | 2pm AEDT On demand available after final airing Mar. 31, 2021 Register free

Oligonucleotides are a chemically distinct class from small-molecule or protein therapeutics and present their own unique challenges for characterization and quantification. In this webcast you will learn how high-resolution mass spectrometry (HRMS) and microflow LC-MS can help you overcome these challenges and still maintain a high level of sensitivity. Live: Tuesday, March 17, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET On demand available after final airing until Mar. 17,, 2021 Register free