INSIGHTS ON CELL & GENE MANUFACTURING
What You Need To Know About Process Characterization And Validation For Biologic Processes
Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.
Accelerated Commercial Supply With Modular Cleanrooms
Modular cleanroom systems are increasingly chosen over a conventional construction approach due to their accelerated design and installation schedule advantages, as well as their reduced job-site safety risk during installation.
Why Controlling CQAs Isn’t Good Enough For Gene & Cell Therapies
One of the most frequent statements made in the biopharmaceutical industry is the need to “control a product’s critical quality attributes (CQAs) by controlling the process’ critical process parameters (CPPs).” While the statement is accurate literally, it does not convey the true technical requirements for controlling product quality.
Modular Pharmaceutical Cleanrooms
AES Clean Technology provides complete pharmaceutical modular cleanroom project delivery with guaranteed performance. Our integrated products + solutions offering provides risk mitigation with single-source responsibility.
Gene Therapies: Overcoming The Biggest Hurdles In Manufacturing
The last decade saw a great rise in gene therapy popularity. Today, gene therapies have reached a momentum with hundreds in clinical development and several therapies approved in recent years. However, the rapid growth of the sector and the complexity of gene therapies has resulted in a number of challenges in process development, scale-up, manufacturing, and regulatory guidelines. See how a CMO can help you maset gene therapy manufacturing.
Efficient DNA Clearance: Better, Faster, Virus Production
In viral vector purification, free nucleic acid not only poses a threat to patient safety but also decreases product yield. Discover how to remove DNA from your gene therapy process and meet regulatory expectations.
Stemline® XF MSC Medium Has High Yield And Functionality In The 3 L Mobius® Stirred Tank Bioreactor
Optimizing ex vivo cell expansion processes in preparation for clinical use is a critical step in cell therapy manufacturing. Here, we discuss the performance of Stemline® XF MSC Medium, which promotes expansion of human mesenchymal stromal/stem cells (hMSCs) to high densities while maintaining cell identity and quality.
BioReliance® Gene Therapy Services
We are your partner for manufacturing and testing of viral gene therapies and gene-modified cell therapies. We offer manufacturing and biosafety testing for every stage of gene therapy development.
Three Essential Considerations For Cryopreservation Of Cellular Therapies
Cryopreservation helps cells survive both cooling to extreme temperatures and thawing back to physiological conditions. While several factors come into play, here are our top three considerations for developing cryopreservation processes that will ensure the safe and effective manufacturing of cell therapies, with minimal variability and risk to patients.
Strategies To Address The Viral Vector Manufacturing Shortage
Accelerating the production of your viral-vector based therapy requires you to understand the strategies available to address the viral vector manufacturing shortage as well as selecting the most cost-effective solution for advancing your therapeutic.