03.13.24 -- FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance

The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the research community.

Increased investment in allogeneic therapies and process-level advancements to achieve commercial scale are paving the way for streamlined, standardized cell therapy development and manufacturing.

Unlocking the potential of AI and ML, digital twins, and other advanced analytics for accelerated drug discovery requires good data on which to build upon.

Discover examples of visible particle identification and the root cause investigation, along with a discussion of the performance of additional troubleshooting, using advanced and innovative technologies.

Examine the steps of cleaning validation for both low-volume and high-volume manufacturers and the important role these studies play.

Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.

Determining ideal media composition for a bacteria is critical because it fosters a satisfactory grow rate, allowing the bacteria to reach the required growth yield.

Hear from a senior GMP scientist about environmental monitoring and contamination control for aseptic pharmaceutical manufacturers, along with the impact of effective cleanroom monitoring.

How can you face the challenges of AAV production, scale up your AAV manufacturing effectively, and enhance the recovery and purity in your downstream processing?

Explore results from a study demonstrating the capability of an intensified, single-use downstream process for a fed-batch cell culture harvest producing a representative mAb at an industrial scale.

The first line of defense against cold chain failures is the integrity of freezing containers during storage and shipping. Explore "robust by design" single-use solutions in cold chain management.

Researchers working with PNPs to provide efficient and targeted treatments are facing challenges with scaling up manufacturing and production.

mAb success hinges on choosing the right cell line. Learn how making an informed decision helps to lay the foundation for a successful mAb development project, unlocking its full potential.

In a recent episode of Business of Biotech, Philogen CEO Dr. Dario Neri sat down to explore his journey from academia to startups, as well as Philogen's own trajectory.