Newsletter | August 20, 2024

08.20.24 -- Inside Next-Gen Platforms For Cell Therapy Manufacturing

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Cell and gene therapy producers—make sure you're meeting regulatory quality standards with absolute quantification and sizing of HEK293 residual DNA. Download your free copy of the eBook.

FEATURED EDITORIAL

Inside Next-Gen Platforms For Cell Therapy Manufacturing

With additional cell therapy approvals on the horizon, diverse products and platforms are needed to help ensure safety and efficacy in manufacturing, increase speed to market, and decrease overall CoGS.

INDUSTRY INSIGHTS

Enhancing Development And Mitigating Challenges With Plasmid DNA

Plasmids, essential in biologics manufacturing, pose challenges in their development and scale-up due to difficulties integrating and optimizing them with the appropriate cell lines during process development.

4 Milestones On The Path To Neurological Cell Therapy

How did we arrive at neurological cell therapy solutions? Dr. Ole Isacson explores the stem cell steppingstones — from blood transfusions to Parkinson’s Disease treatments.

Weighing FSP Model Suitability For Clinical Trials

Consider several key points outlined in this article when deciding if a functional service approach could better serve a clinical team and its drug development study.

Outsourcing Process Development: Key Considerations For Biopharma

In Best Practices for Outsourcing Process Development, a panel of experts discussed four themes that may help drive the best outcomes when vetting process development service providers.

Effective Contamination Control Strategies: Cleaning And Disinfection

Watch to explore the relationship between a Contamination Control Strategy (CCS) and the development of a robust cleaning and disinfection program for cleanroom environments.

Ask The Expert: Single-Use Technology In Cell And Gene Therapies

As CGT developers gain knowledge about their processes, SUT manufacturers can better address the sector's unique autologous needs by adapting to smaller-volume production.

How To Ensure Virus Bank Manufacturing Success

Review the processes and best practices applied at a GMP facility to optimize the production of working virus seed stocks and master virus seed stocks.

Why Single-Use? SUT In Pharmaceutical Manufacturing

Learn about the role of single-use technology in advanced therapy manufacturing, why pharmaceutical manufacturers are switching to disposable technology, and more.

Advancing 3D Cell Culture Models For Clinical Relevance

Concerns about in vitro relevance and animal study limits have advanced cell culture tech. Discover how Organ-Chips offer a refined approach to studying human physiology.

Streamlining Change Control To Increase Efficiency And Compliance

Here, we outline a holistic approach to streamline the change control process, aiming to increase efficiency and compliance, improve quality, and shorten time-to-market.

Exploring Electroporation: Genetic Diseases

This collection of articles explores the role of genetic engineering in understanding, preventing, and treating genetic diseases.

Generate High Quality Data And Execute Full Factorial Design Of Experiments

See how a bioprocessing company supplemented their in-house bioreactor capacity and performed large-scale DOE studies using a cloud bioreactor facility.

Maintaining A Nuclease Free Environment During mRNA Production

mRNA are singled-stranded, and their chemistry makes them more susceptible to enzyme degradation. Get tips for maintaining a nuclease-free environment during production and purification.

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Connect science and compliance at the 19th annual PDA Pharmaceutical Microbiology Conference, October 7 - 9 in Washington, DC, and navigate the crucial nexus between scientific advancement and regulatory adherence! Don’t miss out on directly interacting with the experts, poster presentations, and the Exhibit Hall where leading companies will showcase the latest technologies, equipment, and applications. This conference sells out quickly! View the agenda and register today.

SOLUTIONS

Flexible, Global Delivery For Alzheimer's Patients

Personalized CGT Clinical Development

Support Growth With Material For Cell Culture

A Transfection Reagent For Cost-Effective LV Production

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Don't miss the next Cell & Gene Live discussion on how CAR-T manufacturing has advanced recently and where it's going. Host Tyler Menichiello welcomes CTMC's Jason Bock, Ph.D., Cartesian Therapeutics' Emily English, Ph.D., and former FDA-turned Dark Horse consultant and CMC Expert, Tal Salz, Ph.D., for this digital event happening Tuesday, August 27, at 11 AM ET. Registration is free thanks to the support of CPC.

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