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T cells

New FDA guidance: cell therapies and patient identifiers

When the US Food and Drug Administration (FDA) recently made two draft guidance documents for the cell and gene therapies available for comment, the Vineti team was quick to scan for one three-letter phrase that is core to our mission – COI.

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December 4, 2019

Data management for advanced therapies, Part 1: the need for new strategies

Note: this post is the first of an eight-part series on data management strategies for personalized therapies, such as cell...

December 4, 2019

Data management for advanced therapies, Part 2: unique data features

Note: this post is the second of an eight-part series on data management strategies for personalized therapies, such as cell...

October 30, 2019

Chain of Identity and Chain of Custody in personalized therapies — core differences from traditional pharma

In pharmaceutical manufacturing, Chain of Identity and Chain of Custody may not be new — but in advanced therapy manufacturing,...

October 17, 2019

Supply chain vs. value chain: need-to-know essentials

In a recent blog post about Quality Risk Management, we talked about the importance of considering the entire “value chain” when...

August 27, 2019

In September, here’s why it’s all about data management

Next month, my colleagues at Vineti and I will be speaking, writing, and presenting on a topic of critical importance...

August 22, 2019

September events! A Big Data webinar with Dr. Scott Burger, and a talk at CAR-TCR Summit

September marks the start of the autumn conference season in cell and gene therapy, and this fall I’m looking forward to...

June 19, 2019

Cell therapy standards in action — a new case study on labeling

In cell therapy and gene therapy, in-process and final product labeling matters more to patient safety than ever before —...

June 12, 2019

ISCT 2019: data elements in the cell therapy value chain

I just got back from speaking at the International Society for Cell Therapy annual meeting, where the topic was next-gen data management....

May 2, 2019

Commercial lessons for clinical-phase success, Part I: it all starts with collaboration

In early-phase clinical research, it’s common to think that your science resides within your lab. But when it comes to...

April 23, 2019

Cell therapy labels that work — pointers to keep your patient and your product in sync

In cell therapy, smarter labeling means greater safety and speed. If you’re a cell therapy developer, you have a make-or-break...