Newsletter | March 28, 2024

03.28.24 -- Optimizing CGT Development: Modular Approaches And Cryopreservation Insights

Adopting Modular, Semi-Automated Approaches To Optimize CGT Development

Novel approaches are necessary in biopharmaceutical development for early-phase workflows to accelerate timelines and reduce cost and risk. For both process and analytical development (PD and AD) in advanced therapy space, the drive toward more automated and closed processing has led to unprecedented innovation aimed at standardizing these workflows to the same degree as more incumbent therapeutic modalities.


Cryopreservation Best Practices For Cell & Gene Therapy Source Material

Gain key insights from industry experts on cryopreservation's role in preserving cellular source materials. Discover how cryopreservation works and how experience across different cell types and methods can make all the difference in ensuring successful outcomes.


In Focus: The C Of CDMO

CDMOs play vital roles in the cell therapy industry. Developing a successful CDMO relationship involves navigating complex intricacies, building a robust contract, and adopting a collaborative approach based on shared goals, open communication, and unwavering commitment. By following these principles, you can maximize the potential of your cell therapy program.


Setting Expectations For Post-Thaw Segment QC Testing On A CBU

The selection process of cord blood units (CBU) requires thaw quality control (QC) testing to verify the quality and potency of stored cells. Examine the post-thaw segment QC results for 2,249 consecutive segments cut at our institution, in order to create a benchmark of what is to be expected when interpreting segment testing.


Monitoring Cord Blood Inventory Reliability By Key Quality Indicators

Ensuring the safety and effectiveness of cord blood units (CBUs) for transplantation requires validated processing methods and appropriate storage conditions. However, it is also crucial to have a final verification process to monitor the quality of the CBUs released for transplantation. In this regard, we present a retrospective analysis of our program's final verification process.



Phase-Appropriate Process Development Support

In cell and gene therapies, your process is the product. Our team of experts develops, defines, and refines processes for maximum efficiency and scale.

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Analytical Control Strategy For Your Product Life Cycle

Our team has decades of cell and gene therapy development experience and can help you achieve maximum return on investment.

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