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Pathway to GMP Expectations for Gene-Modified Cell Therapies

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"Pathway to GMP Expectations for Gene-Modified Cell Therapies"

Streamline your clinical cell therapy with our GMP-compliant ribonucleoprotein (RNP) manufacturing as you scale up without compromising on quality to tackle complex regulatory requirements.

Moving beyond research and development, gene and cell therapy developers face significant challenges when initiating clinical programs that rely on CRISPR technology. Scaling up a program without compromising on quality is critical for clinical success.

To help navigate this challenging landscape, Aldevron offers manufacturing batches of ribonucleoprotein (RNP) for clients to scale up and meet regulatory requirements.*

Read our whitepaper, “Expectations on the pathway to GMP for Gene-Modified Cell Therapies” that provides insights into:

  • Regulatory expectations
  • Preparing for GMP manufacturing
  • Partnering for success

Understanding the critical process parameters and critical quality attributes can improve product consistency, enhance clinical outcomes for patient safety, and satisfy the regulatory expectations.

Read this whitepaper to learn how working with an experienced partner in GMP manufacturing can help speed up your pathway to clinic.

*Aldevron provides RNPs only to customers who are duly licensed, including to make and have made RNPs, for their intended use.


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