Newsletter | May 7, 2024

05.07.24 -- CGT: An Overview Of FDA Regulatory Considerations For 2024

SPONSOR

Bringing 400+ mRNA experts to Boston this July, the 4th mRNA-Based Therapeutics Summit returns to share exclusive scientific and strategic insights spanning the end-to-end of mRNA drug development. Select your sessions from 4 tracks of content dedicated to Discovery, Translation, Clinical Development or CMC, and join the Next Generation mRNA Delivery Day or Regulatory Affairs Strategy Day to maximize your learnings. See the program

FEATURED EDITORIAL

An Overview Of FDA Regulatory Considerations For 2024

This article provides an overview of recent regulatory developments from the U.S. Food and Drug Administration that are pertinent to sponsors pursuing the approval of cell and gene therapies in the United States.

The Importance Of Potency Assays

Hear from Kathryn Golden, the Senior Vice President of Technical Operations and Cell Manufacturing at bit.bio, as she addresses the importance of potency assays.

INDUSTRY INSIGHTS

Cell Therapy Milestones, Challenges, And Forming The Future Of TILs

What enabled the evolution of TIL therapies? What does the future hold for them? And where should you concentrate your efforts to accelerate progress? Watch for answers to these questions and more.

Addressing Vulnerabilities In Pharmaceutical Supply Chains

Ensure a stable and reliable supply of essential medications for patients by proactively tackling pharmaceutical supply chain challenges and embracing innovative risk management strategies.

Meeting GMP Requirements For Allogeneic Cell Therapies

Learn why failure to include at least some elements of GMP in your cell line design and development process could make it more difficult to get the data required for future IND or BLAs.

Reliable Analysis Of Antigen-Specific T Cells From Human Blood

Here, we introduce an optimized workflow for analyzing rare antigen-specific T cells from human blood and PBMCs and address critical challenges.

5 Surprising Findings From OT Vulnerability Assessments

Explore operational technology vulnerability assessment findings that may be unexpected or unanticipated, answers to questions about OT vulnerability assessments and pentesting, and more.

Evaluating CAR T Cell Therapy Vascular Recruitment, Trafficking, And Killing

Discover a more human-relevant platform that enables researchers to assess the trafficking and killing efficiency of immunotherapy as well as the proof-of-concept of immuno-oncology co-therapy.

Harvest Of HEK Cells In Extracellular Expression Systems

Evaluate the performance of a single-use centrifuge biopharmaceutical organizations can utilize in the clarification of Expi293F cells through its measuring of supernatant turbidity and viable cell recovery.

Applying High Throughput Processes To Optimize AAV Titers

A growing number of AAV product developers are recognizing the value in moving to suspension as early in development as possible in order to optimize production.

Guide To Seeding, Expanding, And Harvesting Stem Cells

Investigate important considerations for working with three different stem cell types: mesenchymal stem/stromal cells, induced pluripotent stem cells, and neural stem cells.

Introducing A Cell Line Mimic To Support Acute Myeloid Leukemia Diagnosis

In this study, synthetic acute myeloid leukemia (AML) mimic technology was deployed to tackle the AML control challenges faced by a leading global pharmaceutical company.

SPONSOR

Genome editing holds immense promise for treating genetic diseases, but off-target effects remain a significant concern. To ensure the safety and efficacy of genome editing therapies, researchers are developing various strategies to reduce off-target effects. Register today for the next Cell & Gene Live. Attendance is free thanks to the support of Bio-Techne.

SOLUTIONS

RNA-LNP Manufacturing Technology Delivering Transformative Medicines

An Introduction To Isolated Robotic Aseptic Filling Systems

Benefits Of A Patient-Centric Design In Oncology Trials

Ready-To-Hydrate Buffers And Media

GORE STA-PURE Flexible Freeze Container Bag

Bioreactors And DOE Expertise To Characterize Your Process Prior To PPQ

Connect With Cell & Gene: