Newsletter | July 9, 2024

07.09.24 -- The Rising Tide Of Ophthalmologic Gene Therapies

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Clinical Research As A Delicate Ecosystem

Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors. Entrust that your program is in hands you can rely on, where integrity is paramount, and excellence is the standard.

FROM THE EDITOR

The Rising Tide Of Ophthalmologic Gene Therapies

There’s an explosion of clinical activity in the gene therapy space for inherited retinal diseases (IRDs). Atsena Therapeutics' CMO, Dr. Kenji Fujita, explains what makes IRDs such appealing gene therapy targets and shares the company’s strategic approach to clinical development.

INDUSTRY INSIGHTS

Exploring Osmolality As A CQA Within RNA Therapeutics

Discover how osmolality can be applied throughout the bioprocessing workflow for RNA, and recognize the importance of this measurement, from formulation optimization to cryopreservation techniques.

Producing Therapeutic Cardiomyocytes From iPSC Stem Cells

Experts from Albumedix and Heartseed show how they navigated challenges on the path to commercialization and successfully advanced a promising cardiomyocyte therapy to clinical trials.

Optimizing And Scaling Lentiviral Vector Production

Here, we outline how the upstream and downstream workflows of the VirusExpress® platform for lentiviral vectors were optimized through the use of design of experiments and supplementary studies.

How Cell And Gene Therapies Are Evolving

Advances in manufacturing technologies and equipment are improving the efficiency and reproducibility of cell and gene therapies and helping overcome the current supply and demand imbalance.

Analyzing Critical Quality Attributes Of Monoclonal Antibodies

Use microchip CE-MS technology to achieve quicker peptide mapping analysis, high sample reproducibility, and low artificially induced modifications.

Defining And Implementing Global Data Standards And Governance

Learn how ProPharma's expertise in data standards and governance is transforming research and development for a global biopharma leader.

Discover A Reference Control Alternative To HIV+ Donor Samples

A Fortune 100 pharmaceutical company successfully tackled its HIV treatment research challenges by partnering to obtain a p24-expressing, non-infectious synthetic T cell mimic.

Navigating The Road To Reality For Allogeneic Cell Therapies

Allogeneic cell therapies show significant clinical potential, yet they present distinct challenges. In this article, we provide tips to simplify the translational process.

4 Ways To Strengthen Patient Engagement In Clinical Trials

Interest in clinical trials is rising, with more people willing to participate. Uncover four ways to strengthen patient engagement and enhance their experience in clinical research.

Accelerate Cell Expansion And Sustain Viability With A Serum-Free Medium

See how Corning's Insect Cell serum-free medium outperforms other commercial media in yield, doubling time, and cell viability by diving into the study results.

The Future Of Aseptic Connections In Cell And Gene Therapies

Examine open small format tubing in cell and gene therapy labs – and what technologies are on the horizon to help make more sterile connections going forward.

Enable Custom Chromatography Solutions For Downstream Processing

This study explores the development of a POROS prototype resin, investigating ligand immobilization, optimizing coupling conditions, and evaluating bead morphology impact on resin performance.

The Execution Stage Of Technology Transfer

What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.

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KSQ Therapeutics' CSO, Micah Benson, Ph.D., joins Cell & Gene: The Podcast host, Erin Harris, to discuss how Tumor-Infiltrating Lymphocytes (TILs) as a treatment modality have the potential to treat a variety of solid tumor types. Benson explains KSQ's Phase 1/2 clinical study, KSQ-001EX, which consists of TILs in which the SOCS1 gene is inactivated by CRISPR/Cas9 gene editing. Listen now and subscribe so you never miss an episode!

SOLUTIONS

Aseptic Processing Solutions For Small-Scale Filling Applications

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Innovative Product Solutions For CAR T Cell Research And Discovery

Stainless Steel Centrifuges for Cell and Gene Drug Manufacturing

Freezing Studies For Single-Use Solutions: Controlled-Rate (Part 1)

Non-Viral In Vivo Transfection - Cationic Lipids For LNP Formulation

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