Newsletter | April 23, 2024

04.23.24 -- Inside Tenaya Therapeutics' AAV9-Based Gene Therapy

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Webinar: Safety at the Center – The Synergistic Role of Drug Safety in Clinical Trial Operations

In drug safety and pharmacovigilance, collaboration isn’t just a buzzword—it’s an essential component that can impact patient safety and the success of your product. Join us in this webinar as we highlight the importance of effective interpersonal leadership in your drug safety program and reveal the operational and financial efficiencies that can result from a collaborative dynamic. Click here to learn more.

FROM THE EDITOR

Inside Tenaya Therapeutics’ AAV9-Based Gene Therapy

Tenaya Therapeutics, based in South San Francisco, aims to develop curative heart disease therapies. Here, CSO Tim Hoey, Ph.D., explains how the company's gene therapy, TN-401, may treat heart disease.

INDUSTRY INSIGHTS

Precision Oncology Clinical Trials And Statistics 2024

This invaluable resource offers a gateway to the latest in precision medicine, clinical trials, and the transformative potential of targeted therapies in oncology.

Gene Therapies: A Guide To Aseptic Single-Use Connectors

It's important to frequently evaluate your manufacturing process, gauging if improvements can be made. Learn how aseptic connections can impact your efficiency and speed as you continue to scale-up.

A Scalable Single-Use Two-Step pDNA Purification Process

Evaluate the performance of a single-use two-step plasmid purification process and see how it compares to the existing three-step purification method.

Running Statistically Powered Clone Screening Experiments

Discover how conducting a power analysis can determine the correct sample size for a statistically powered clone screening experiment.

Life Science Sterile Filtration And Optimization For Single Use Integration

Explore how filtration manufacturers optimize materials for performance and integration within single-use systems, including the value of optimizing sterile filtration and maximizing performance.

Monitoring Cell Health Is The Key To Successful Cell Therapy

Cell health and quality are key determinants of the safety and efficacy of cell therapy. Review this portfolio of necessary controls that can increase accuracy by removing dead cells.

Comparing Analytical Approaches For AAV Characterization

The choice of AAV analysis method depends on several factors. Here, we prove that mass photometry is a favorable method due to its accuracy, versatility, and low time, sample, and expertise requirements.

How Continuous Improvement Ethos Serves Patients And Clients

Examine how years of experience bolstered by continuous improvement efforts, enable hybrid clinical trial execution, from in-home clinical visits to site networks and digital platforms and technology.

HEK293T Cell Expansion Protocol Using A Hollow-Fiber Bioreactor System

Find out the steps teams can take to optimize reliably control environmental factors related to glucose, lactate, and pH using an HFB system during automated expansions of HEK293T cells.

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Dr. Peter Marks discusses regulating CGT at ASGCT

Join CBER Director Dr. Peter Marks for two engaging fireside chats during ASGCT’s 27th Annual Meeting, May 7-11. On Wednesday, May 8, Dr. Marks will discuss FDA’s regulatory considerations at every stage of the product development process. On Thursday, May 9, he and senior leaders from global health authorities will share comments on the current outlook for CGT development in 2024 and beyond. Attend virtually or in person. Rates increase May 6.

SOLUTIONS

An Introduction To The Sepax C-Pro Cell Processing System

Kinetex Core-Shell Technology Columns For HPLC Or UHPLC Methods

Demo Of At-Line Cell Culture Media Analyzer

So Long, SDV! Experience Speed And Safety With Automated Source Data

RevIT AAV Enhancer: Higher Titers For Recombinant AAV Production

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Breaking down the latest in allogeneic therapy research as well as immunogenicity and the strategies needed to deliver clinically successful and long-lasting off-the-shelf treatments to patients in oncology. Don’t miss the next Cell & Gene Live. Supported by Thermo Fisher Scientific. Register now

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