12.23.25 -- Why Do So Few Cell Therapies Make The Leap From Lab To GMP?

Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

Learn more about the potential of microRNAs as therapeutic targets being investigated for a number of different disease states.

Address the rising gene therapy demands with an innovative perfusion strategy that significantly boosts cell density and viral vector yields to pave the way for scalable, efficient manufacturing.

Explore filtration strategies that improve viral vector yield and quality, with insights on AAV and lentivirus workflows, plus practical guidance for implementing PUPSIT in line with requirements.

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

Review the use of a recombinant trypsin in cell culture applications, such as the detachment of adherent cells, in particular with cell lines used in vaccine production.

Uncover how to achieve high yields in vaccine production by using Cation Exchange Chromatography for purifying SARS-CoV-2 spike proteins. This method provides high purity and minimizes protein aggregates.

Maximize mesenchymal stem cell (MSC) expansion with a simplified culture process. New data demonstrates a high-performance, xeno-free media that eliminates the need for coatings or media exchanges.

Look at an advanced electroporation platform that enables reliable, large-scale, non-viral delivery of complex gene editing tools like CRISPR/Cas9 for T-cell manufacturing.

Digital PCR enables fast, sensitive mycoplasma detection in cell-based products. Take in how this pharmacopeia-compliant workflow improves accuracy, reduces delays, and supports reliable decision-making.

Scaling up life-saving gene-edited cell therapies means tackling production inefficiencies. Overcoming the time-consuming and risky cell washing step is crucial for clinical and commercial success.

Discover how Germfree tackled a unique challenge from the Public Health Agency of Canada by designing a custom Class III biosafety cabinet for advanced virology studies and disease surveillance.

By following the five steps of a specialized protocol, exceptional yields and stable cell lines can be achieved in CHO cells using antibiotic selection.

Until recently, only isolated solutions for working filling, freezing/thawing and transporting sensitive drug materials were available. Find out how we've addressed this problem with end-to-end bottle solutions.