Having an appropriate assay to detect host cell proteins (HCPs) is critical in biopharmaceutical development, including the development of gene therapy products. To ensure accurate quantitation of HCPs during the bioproduction process, process- or platform-specific HCP assays are preferred over generic assays. In this session, the development of custom reagents for process-specific HCP ligand-binding assays is described, as well as the development of custom HCP assays on two different platforms (ELISA and Gyrolab immunoassay platform) for product release and in-process support.

Educational benefits of this presentation:

• Learn about the importance of HCP assays in biopharmaceutical development and bioproduction processes
• Understand the development of custom immunoassays for HCP detection
• Compare HCP assay performance and throughputs on 2 different platforms

Speaker:

Emily Menesale
Scientist II, Analytical Development
Ultragenyx

Accurate, easy and rapid methods for AAV total capsid titer and empty versus full determination are highly sought-after. Various methods based on different bioanalytical techniques are employed currently for capsid characterization. AAV total capsid determination and empty versus full ratio calculation is particularly challenging in the upstream crude samples due to matrix interference and low concentrations. Gator Bio has developed Biolayer Interferometry (BLI) based simple methods that enable AAV researchers and manufacturers to accurately and quickly characterize both upstream and downstream samples. The automated methods use Gator Bio’s next-gen BLI platform with innovative biosensors that enable high-sensitivity, minimal matrix interference, and hands-on time, and high-throughput. This talk will present the methodology and results comparison on samples from upstream, downstream, and final product formulation.

Speaker:

Indrani Chakraborty
Senior Scientist
Gator Bio

Viral vectors, such as adeno-associated virus (AAV) and lentivirus (LV), are widely used in gene and cell therapies. To ensure the safety and efficacy of these emerging therapeutics, it is critical to fully characterize the viral vectors throughout the development process, as well as quantify their critical quality attributes (CQAs) across manufacturing and quality control. In this webinar we will discuss how dynamics light scattering (DLS) and multi-angle light scattering combined with size exclusion chromatography (SEC-MALS) or field-flow fractionation (FFF-MALS) characterize AAV, LV, and other gene delivery vectors. Biophysical properties and attributes covered by these techniques include size, concentration, aggregation, stability, and capsid content.

Key learning objectives:

• How DLS screens viral vectors for size distribution, aggregation, particle concentration, and stability.
• How SEC-MALS quantifies three critical quality attributes (CQAs) of AAV samples: particle titer, capsid content, and aggregation.
• How FFF-MALS characterizes and quantifies large viral vectors (e.g. LVs) and other DNA/RNA delivery vehicles (e.g. lipid nanoparticles).

Speaker:

Michelle Chen, Ph.D
Vice President of Analytical Sciences
Wyatt Technology Corporation

Gene therapies commonly utilize adeno-associated virus (AAV) vectors to deliver a therapeutic transgene to patient cells. With a growing demand for gene therapies and high treatment costs, it is important that the transient plasmid-based technologies used to manufacture AAV vectors are as efficient and cost-effective as possible. Innovators can reduce these costs, increasing access to gene therapies, by examining these manufacturing technologies and investing in high-producing single clonal cell line, high-quality plasmids and efficient process development ahead of GMP manufacture.

In this webinar, you will learn about:

• The importance of a high-producing single clonal cell line, high-quality plasmids and manufacturing systems to produce high-quality viral vectors at high yield
• How a combination of upstream and downstream process development can enable efficient AAV manufacturing solutions
• The development of a robust, scalable AAV transient suspension expression system at WuXi Advanced Therapies and the benefits that this system brings to our customers' projects for GMP viral vector manufacture

Speaker:

Bibek Ghosh
Associate Principal Scientist, Viral Vector Process Development
WuXi Advanced Therapies

With Gene Therapy rapidly shifting from orphan to prevalent indications, the demand for viral vectors is surging — especially the demand for AAV. Yet the industry is still largely operating on the legacy process of transient transfection, which requires large amounts of expensive GMP-grade DNA while carrying only limited scale-up potential. Nobody would consider such a process for industrial antibody production, but it still is the norm for AAV. The ELEVECTA platform of inducible stable AAV producer cell lines solves this issue. This webinar will dive deep into the ELEVECTA® Technology, and participants will understand how they can produce high-titer, high-quality AAV vectors as easily as antibodies.

Speaker:

Dr. Markus Krieger
Vice President Technology Development
CEVEC Pharmaceuticals GmbH

Adherent methods for lentiviral vector (LVV) production are widely used as these processes are easily available, require minimal investment to implement, and have been successfully utilized for commercially approved gene therapy products. However, adherent methods have shown their limitations due to lack of scalability, high variability, challenges with consistently meeting safety and efficacy requirements, and unsustainable costs for commercialization.

Next month, Sanyal Suparna (Head of Viral Vectors Commercial Development, Lonza) will join Viral Vector Digital Week to discuss how Lonza’s LVV suspension platform addresses these challenges and how to secure commercial viability for your gene therapies.

As a webinar attendee, you will gain insights into:

• The pros and cons of adherent LVV production methods
• The need for 3D platforms to scale-up production of LVVs
• How to achieve high LVV productivity using Lonza’s novel 3D platform

Speaker:

Sanyal Suparna - Houston
Director, Commercial Development, CGT, Sales Business Development
LONZA

Gene therapies have the potential to revolutionize the landscape of advanced therapies and personalized medicine. Expediting process development to move from gene to clinic as fast as possible will be critical to meeting patient needs. This talk will discuss how leveraging a manufacturing platform can expedite the critical path from clinical to commercialization, focusing on Fujifilm’s AAV platform and supporting phase-appropriate analytical methods.

Speaker:

Matthew Vaughan
Technical Project Leader
FUJIFILM Diosynth Biotechnologies

Join Yatindra Tirunagari, Head of Process Development and Gaurav Bhavsar, Head of GMP Operations in an interactive session, where they take you through our Rentschler ATMP approach for AAV process development and manufacturing. Yatindra will address potential challenges that are common during development and tech transfer, and what strategies can be best applied to solve them. Gaurav will delve into aspects of scale up and manufacturing and elaborate on end-to-end integrated manufacturing and single use disposable manufacturing.

Speaker:

Yatindra Tirunagari
Head of Process Development
Rentschler Biopharma

Gaurav Bhavsar
Head of GMP Operations
Rentschler Biopharma

Lentiviral vectors are important gene delivery tools for cell and gene therapies, notably CAR-T cell therapies which have demonstrated success in the treatment of blood malignancies. As the number of clinical trials for Lentiviral-based therapies increases, it becomes even more important that the methods used to manufacture Lentiviral vectors perform consistently and efficiently. However, the technologies used to produce viral vector on a small scale early in drug development often do not perform as efficiently when used at the higher scales needed at GMP grade for clinical trials. Drug developers can maximize their chance of success by carefully considering their Lentiviral vector production method and by working with an experienced partner organisation to deliver on their goals.

In this webinar, you will learn about:

• The importance of generating high-quality, high-yield Lentiviral vectors for addressing an industry need within cell and gene therapies
• The challenges involved with scalable Lentiviral vector manufacture
• How LentiVEX™ plasmids are engineered for viral vector yield, quality, and safety
• Performance of the WuXi Advanced Therapies LentiVEX™ suspension platform and the benefits that this system brings to our customers' projects for GMP viral vector manufacture
• Development of producer cell line for next generation LentiVEX™ platform

Speaker:

Yu-Pin Su, PhD
Associate Principal Scientist, Viral Vector Process and Technology Development
WuXi Advanced Therapies

Filtration offers one of the simplest and most robust unit operations in biomanufacturing, and due to its straightforward size-based mechanism of action, it is well-suited for purification of viral vector products. For instance, using a microfiltration process for harvest clarification can negate the need for multiple stages of centrifugation and depth filtration while achieving excellent removal of cells and debris and reducing turbidity. On the other hand, virus filtration can provide robust viral clearance in the downstream process for smaller viral vectors and ensure removal of potential contaminating viruses upstream for all viral vectors. In this session, we will discuss these applications of filters and how they can be leveraged to improve viral vector manufacturing efficiency.

Speaker:

Daniel Strauss, Ph.D
R&D Director
Asashi Kasei