Newsletter | September 10, 2024

09.10.24 -- How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield

FOCUS ON MANUFACTURING

How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield

This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs. 

Aseptic Filling And Processing Considerations For Biosimilars

One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Explore the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.

Guidelines To Bring Your Drug To Market: Are You Prepared?

Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here, we explore this from a biopharma process development and manufacturing perspective.

Engineering With A GMP-Compliant, Scalable Electroporation Platform

This presentation explores natural killer (NK) cells and how conditions for electroporating primary NK cells can be optimized to improve cell viability, transfection efficiency, and other factors.

Key Elements For An Improved CAR-T Therapy

Watch to learn about a new serum-free T cell media designed to overcome the barriers hindering CAR-T therapies and explore the importance of transduction efficiency in CAR T-cell therapy.

Flow Cytometric Assays For CAR T Cell Manufacturing, Patient Monitoring

Unprecedented efficacy in targeting cancer has been demonstrated with CAR T-cell therapy. Discover a device that allows the generation of CAR T-cells in a single automated and closed system.

Monitoring Cell Health Is The Key To Successful Cell Therapy

Explore a portfolio of necessary controls for assessing cell health that can increase accuracy through the removal of dead cells.

Demonstrating Analytical Comparability In Analytical Development

Get an overview of how mass photometry works and the effort being put in to establish an analytical workflow for gene therapy products.

Overcoming Bispecific Antibody Purification Challenges

Enhance the quality and safety of your BsAb therapeutics with a highly efficient with the right chromatography hydroxyapatite media.

Precision Volume Accounting In Fed-Batch Cultures

Are you searching for a better way to calculate growth rate? Consider a new approach that performs the rate calculations using a simple method to correct for volume changes.

Improve Sterile Drug Quality With Parenteral Filtration

Better understand the differences between large- and small-volume parenteral injectable drugs, their comparative sizes, types, sterilization processes, and applications.

SPONSOR

The supply chain for mRNA-based cell and gene therapies presents unique challenges due to the sensitive nature of these products. Join Cell & Gene Live on September 24th for a digital discussion on how the industry can improve the efficiency, reliability, and scalability of the supply chain for mRNA-based therapies. Registration is free thanks to the support of Roche CustomBiotech.

MANUFACTURING SOLUTIONS

Innovative Solutions For mRNA Vaccine Manufacturing - Polyplus

Magnetic Bead Tech For Plasmid DNA Purification - Thermo Fisher Scientific

Unleash HEK Cell Potential With Cell Growth Supplements - Advanced Instruments, Inc.

Producer Cell Line To Elevate Your AAV Production To The Next Level - Cytiva

Frequently Asked Questions: Corning CellCube System - Corning Life Sciences

An End-To-End Solution For Enterprise Quality Management - Honeywell Process Solutions

SPONSOR

Webinar: Cleanroom Conceptual Design Paradigm: Converting Spaces for GMP Operations

This webinar on September 26, 2024, at 11:00am EDT, will explore designing life sciences cleanroom spaces that allow for the development of the science and the capability to host commercial scale GMP manufacturing. Learn more about an integrated design process that gives confidence for regulatory alignment, optimal design functionality, and environmental performance.

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