Webcasts

2020 Bio/Pharma Virtual Congress

*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021***

Applying ISO 10993-18 on Extractables & Leachables Characterization—Supporting the Medical Device Regulatory Pathway

***Live: Friday, November 20, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET***Chemical characterization of medical device materials within a risk management process, addressed in ISO 10993 Part 18, was significantly revised in 2020. Part of this critical standard is to ascertain the extractables and leachables from a medical device to enable the estimation and control of biological risks. Join us for this webcast to learn about an LC–MS workflow to help address this challenge.***On demand available after final airing until NOV. 20, 2021***

Intact and Subunit MAM Assays Accelerate the Development of Antibody-Drug Conjugates

***Live: Tuesday, November 3, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET*** In this webcast, learn how multi-attribute assays were used to accelerate routine workflows for biotherapeutics characterization at the intact and subunit level. This new streamlined approach increased the efficiency to perform stability assessment of antibody-drug onjugates (ADC) significantly.***On demand available after final airing until Nov. 3, 2021***

Characterization of Viral Vector Particles with LC–MS

*** Two Live Events! Monday, Oct. 26, 2020 at 9am EDT| 1pm GMT| 2pm CET and Monday, Oct. 26, 2020 at 2pm EDT| 1pm CDT| 11am PDT*** Join us for this web seminar to learn about the utility of mass spectrometry for characterizing adeno-associated viruses (AAVs), including how intact mass spectrometry can accurately confirm AAV capsid proteins, how AAV post-translational modifications can be identified and confirmed, and how upfront sample preparation can improve mass spec accuracy and resolution. ***On demand available after final airing until Oct. 26, 2021***

Breakthroughs in FFF-MALS – New Levels of Performance and Usability

*** Three Events: Tuesday, Oct. 27, 2020 at 11am EDT| 8am PDT| 3pm GMT| 4pm CET Asia Pacific: Wednesday, Oct. 28, 2020 at 10:30 am IST| 1pm CST| 2pm JST Europe: Wednesday, Oct. 28, 2020 at 9am| 10am CET*** Characterizing complex nanoparticles, polymers and biotherapeutics is about to get a lot easier. ***On demand available after final airing until Oct. 28, 2021***

Vero Cell Cultivation for Vaccine Production

***Live: Thursday, Oct. 22, 2020 at 10am EDT| 9am CDT| 3pm BST| 4pm CEST***Process development for anchorage-dependent cells at bench scale is crucial to establish cost-efficient workflows in larger volumes. Learn how different process parameter can be monitored and controlled in a perfusion bioprocess and the potential of using packed-bed bioreactors or a microcarrier spin filter for attachment cell-based vaccine production.. *** On demand available after final airing until Oct. 22, 2021.***

Host Cell Proteins: Analytical and Regulatory Challenges

***Live: Wednesday, Oct. 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST*** Host cell proteins (HCPs) can compromise a biologic drug and delay its development program. Learn about important considerations for optimizing HCP testing in this webcast. ***On demand available after final airing until Oct. 21, 2021***

ditors’ Series: Mapping the Transition from Drug Discovery to Development and Beyond

***Live: Wednesday, Oct. 14, 2020, at 11am EDT| 8am PDT| 4pm BST| 5pm CEST*** Hear experts review key milestones and tasks—as well as potential stumbling blocks—along the drug development pathway and offer strategies to help discovery-phase drug development programs move from the lab to clinic and commercialization. *** On demand available after final airing until Oct. 14, 2021.***

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