Characterizing clonal evolution in blood cancers like acute myeloid leukemia (AML) is critical for understanding their mutational histories and how cell populations change during disease development.

In this GEN webinar, Robert Bowman, PhD, will discuss his lab’s approaches for modeling clonal evolution in mouse models of disease. His group deploys multi-recombinase models to study the stepwise acquisition of mutations seen in AML. These approaches allow for the evaluation of how mutation order impacts disease development. They have characterized the hierarchy of cellular differentiation using flow cytometry and single cell RNA sequencing, recently integrating the ScaleBio Single Cell RNA Kit into their workflow. He will discuss a specific study focusing on FLT3-mutant AML, present data comparing genetic deletion versus chemical inhibition with FDA-approved tyrosine kinase inhibitors, and finally, his plans to further deploy models of oncogene-dependency.

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.

Novel or next-generation biologics such as bispecific antibodies (bsAbs) and fusion proteins present unique development and manufacturing process challenges due to complex formats, suboptimal stability, product aggregation, or low productivity. These issues impact product quality and consistency, as well as the ability to develop efficient and scalable processes. Successfully addressing these challenges while reducing the cost of goods (COGs) requires the strategic utilization of advanced technologies, appropriate analytical methods, extensive experience, as well as adopting a proactive approach to de-risk the biotherapeutics development.

In this GEN webinar, our speakers will present WuXi Biologics’ suite of advanced solutions for overcoming obstacles associated with the development and manufacturing of complex biologics.

In this webinar you’ll learn:

• The evolving landscape of new modalities and the holistic challenges in CMC development for complex biotherapeutics

• Technical strategies to address specific challenges in bispecific antibody (bsAb) development

• Solutions to achieve efficient and successful fusion protein development in mammalian protein expression systems

• Case studies and experience sharing on strategies to reduce COGs for complex biologic modalities

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelists.

Adeno-associated viral (AAV) gene therapy products, which contain a DNA transgene packaged into a protein capsid, have shown tremendous therapeutic potential in recent years for a range of diseases. Technologies like imaged capillary isoelectric focusing (icIEF) are designed to help scientists make these products a reality by providing an orthogonal, fast, and high-resolution method for AAV charge species collection and characterization. Addressing charge heterogeneity is crucial as it can affect the stability and biodistribution of AAV-based biotherapeutics.

In this GEN webinar, our speakers will discuss icIEF technology and its application to protein charge analysis in AAV gene therapy development. During the webinar, you’ll learn about the MauriceFlex icIEF system, a protein fractionation solution the enables fraction collection for charge variant analysis and eliminates the need for mobilization after separation while providing data in 10-15 minutes. You’ll also hear about recent innovations that enable the direct characterization of charge isoforms by icIEF separation by mass spectrometry (MS) including a novel methodology for AAV viral protein species separation by icIEF and characterization by MS.

Key learnings for this webinar include:

• How the protein fractionation capabilities of MauriceFlex enable fraction collection for charge variant analysis
• A methodology for AAV viral protein species separation by icIEF and characterization by MS
• The advantages of using icIEF fractionation over traditional ion-exchange chromatography (IEX)-based fractionation

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.

There is surging interest (and competition) in the proteomics industry, reminiscent of the state of NGS and genomics a decade ago. While mass spectrometry (MS) technologies remain the tried-and-true method for analyzing the proteome, established MS companies have been joined by a powerful set of emerging technologies offering the ability to survey more proteins, with higher sensitivity, specificity and greater ease. Indeed, some companies aim to detect disease using protein measurements. This is providing researchers who need to assess the proteome choices that they simply did not have before.

On this episode of GEN Live, we will talk about proteomics—as a tool and as a field. Where is it now and what type of research is proteomics enabling? We will also discuss the latest technologies and instruments in this space. What will it take for these new companies to compete?

A live Q&A session will follow the discussion, offering a chance to pose questions to our expert panelists.

Organ-on-a-chip (OOC) technologies are now being used across a range of drug discovery applications, through efficacy and into safety assessment. As the technology and applications evolve, new questions and opportunities are arising in terms of regulatory acceptance, cost efficiency, and model confidence through standardization.

In this GEN Learning Lab, CN Bio’s CSO Tomasz Kostrzewski, PhD, and toxicology consultant Clive Roper, PhD, will discuss all things OOC, including current applications, the evolving perspective of regulators, and ongoing efforts to harness OOCs’ potential in biomedicine.

Key questions addressed during the webinar include:

• How OOC is transforming drug discovery with its predictive and cost-effective approach.

• Discover how OOC tackles rising costs and prepares for the complexities of new drug modalities.

• Reduction and refinement of animal use while maintaining scientific rigor.

• Current industry challenges and how OOC providers are working to overcome them.

• Regulatory acceptance status, including the regulator’s viewpoint on OOC and ongoing efforts to support increased use.

This is an encore presentation. It will be followed by a live audience Q&A session, giving you the chance to pose questions to our experts.

Optimizing RNA encapsulation is vital for formulation development and maximizing delivery to target cells to ensure the success of therapeutics and vaccines. However, assessing the efficiency of the optimization process remains challenging. One solution is single particle analyses using technologies like nano-flow cytometry. This technology makes it possible to simultaneously size and count lipid nanoparticles (LNPs) whilst identifying the presence of cargo or surface modifications to determine efficacy of the nanoparticle loading or functionalization.

In this GEN webinar, Ben Peacock, PhD, will present the NanoAnalyzer platform and describe how it supports multi-parameter analysis and characterization of biological nanoparticles like LNPs. During the webinar, you’ll learn how technology can be used to identify priority subpopulations within samples using exogenous labeling techniques, and how this allows for quantifying RNA cargo or the surface density of various targeting modalities.

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelist.

Although it is one of the most common forms of lung cancer, non-small cell lung tumors remain difficult to treat with current therapies such as tyrosine kinase inhibitors. Efforts to develop new treatments include a focus on novel antibody modalities such as bispecific antibodies (BsAbs). While single agent therapeutic agents have been used to treat various cancers and can help some patients, often the diversity of pathological mechanisms can limit the sustained response. The multifactorial nature of tumors has sparked a growing interest in BsAbs, which are increasingly preferred due to their greater selectivity and efficacy for a broader distribution of patients.

In this GEN webinar, Mark Chiu, PhD, will present a process for selecting an EGFR x cMET bispecific antibody to treat patients with EGFR inhibitor-resistant non-small lung cancer. He will share a strategy for selecting the lead candidate using different in vitro cell based assays as part of a hit to lead selection process. During the webinar, you’ll learn about critical endpoints in in vitro cell-based assays that guide the selection of hits with the highest functional activity as well as strategies for selecting a bispecific format that effectively engages with both therapeutic targets.

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.

Widespread adoption and availability of mRNA therapeutics hinges on overcoming significant manufacturing challenges related to scalability, cost-effectiveness, quality control, and regulatory compliance. Automated RNA production platforms can solve some of these challenges by implementing standardized processes from the research stage all the way through to the clinical and commercial stages. Standards minimize batch-to-batch variability, streamline technology transfers, enhance regulatory compliance, and ensure product stability throughout the development life cycle. They can also help unlock efficiency gains, reduce cycle times, and enhance cost-effectiveness.

In this GEN webinar, Patrick Thiaville, PhD, will explore the possibilities and potential impact of automated RNA production standards on the development of targeted treatments such as mRNA therapeutics and vaccines and personalized therapies. He’ll present data from a case study that demonstrates how automation can help biotech companies fast-track the progress of their therapies and facilitate broad access to RNA-based treatments. Learning objectives for this webinar include:

• Identify the critical manufacturing bottlenecks impeding the widespread availability of transformative mRNA therapeutics and vaccines.
• Discover how implementing standardized and automated RNA production processes from the earliest research stages can address scalability, quality, regulatory, and cost-efficiency challenges.
• Evaluate the quantitative impact of automation strategies through an insightful case study, highlighting accelerated timelines, seamless tech transfers, and facilitated access to RNA-based therapies.

Panelists:

The advent of new therapies brings new manufacturing challenges for biopharma. As an example, subcutaneous injections of high-concentration monoclonal antibodies (mAbs) are already transforming the patient experience. But with up to 10 times greater concentrations, these viscous fluids are pushing the limits of what traditional filtration can handle efficiently. This leads to slow processing and the loss of valuable product. The new range of Supor Prime sterilizing-grade filters from Cytiva changes that.

In this GEN webinar—the global launch event for Supor Prime filters—you will discover one of the biggest breakthroughs in filter performance for a decade. Our expert panel will discuss how the Supor Prime filter range can help you do more and do it faster, thereby accelerating and advancing therapeutics from discovery to delivery. Among the topics covered in this roundtable will be:

• The changing biopharma landscape and the filtration challenges it faces

• How the Supor Prime filter range can double throughput and increase flow rate

• A behind-the-scenes look at the development of the range

• A close-up of the product range showcasing its innovative, user-friendly design.

A live Q&A session followed the presentations, offering a chance to pose questions to our expert panelists.

Produced with support from:

By harnessing the body’s immune system, immune checkpoint inhibitors have improved outcomes for patients with advanced cancers like melanoma and non-small cell lung cancer. However, they have limited efficacy for some tumors such as head and neck squamous cell carcinomas. Currently, only 20% of patients with PD-L1 positive tumors respond to the treatment by a PD-1 inhibitor like pembrolizumab. By incorporating detailed information about the tumor microenvironment, scientists can gain fresh insights about these and other tumors that will lead to more effective therapies and improve patient care.

In this GEN webinar, Quan Nguyen, PhD, and Jazmina Gonzalez Cruz, PhD, will discuss how advances in spatial proteomics and single-cell sequencing are enabling a more personalized approach to treating metastatic recurrent head and neck squamous cell carcinomas. They will share results from their analysis of tumors from patients sensitive to pembrolizumab and lenvatinib and those with reduced lenvatinib sensitivity. You will also hear details about distinct tumor regions and key druggable targets in the tumors as well as a novel cell deconvolution method that improves on existing techniques.

A live Q&A session will followed the presentation, offering a chance to pose questions to our expert panelists.