Diana M. Colleluori

Nov 26, 2024 | cellandgene.com | Diana M. Colleluori |Troy Ostreng |Josh Russell

Despite significant advances, challenges remain in optimizing AAV-based treatments for broader clinical application. Join Cell & Gene Live on December 10th for a discussion on the latest developments in AAV vector design, manufacturing processes, and clinical strategies as well as key issues such as immunogenicity and regulatory considerations that are shaping the future of AAV gene therapies. Registration is free thanks to the support of Roche CustomBiotech.

Nov 26, 2024 | cellandgene.com | Diana M. Colleluori |Troy Ostreng |Josh Russell

Despite significant advances, challenges remain in optimizing AAV-based treatments for broader clinical application. Join Cell & Gene Live on December 10th for a discussion on the latest developments in AAV vector design, manufacturing processes, and clinical strategies as well as key issues such as immunogenicity and regulatory considerations that are shaping the future of AAV gene therapies. Registration is free thanks to the support of Roche CustomBiotech.

Nov 21, 2024 | bioprocessonline.com | Diana M. Colleluori |Chris Ovett |Idbs Hq

Raman Spectroscopy: Monitor In-Vitro Transcription in mRNA ManufacturingRaman spectroscopy is an efficient method for process monitoring and control which empowers the user to navigate mRNA manufacturing with confidence. It enables the direct monitoring of molecular vibrations, offering a detailed chemical fingerprint of NTP bases and mRNA molecules without the need for labeling or extensive sample handling. Learn more about the benefits of Raman technology in IVT in our technical article.

Nov 12, 2024 | cellandgene.com | Diana M. Colleluori

By Diana M. Colleluori, Ph.D., MBA, principal CMC consultant, Biologics Consulting Group Inc. The development of potency assays for cell and gene therapy products (CGTs) may be the most difficult assay strategy to navigate throughout product development, from both a technical and a regulatory perspective. As such, the FDA released the draft guidance for industry for Potency Assurance for Cellular and Gene Therapy Products in December 2023.