Integrated DNA Technologies’ Post

A new era of personalized medicine is upon us. Gene therapies and nanomedicines are at the forefront of this revolution and are changing how we approach disease treatment and prevention. Read this Inside Battelle blog to get smarter on the subject: https://okt.to/kyDB7U

Nice review of "The FDA's recent draft guidance on 'Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products'. The report covers manufacturing changes in investigational products, where alterations fundamentally changing the product design may need a new IND filing, while those leading to acceptable quality can be submitted as an amendment. Also, it guides on post-approval changes for licensed CGT products similar to existing biologic product protocols. The draft introduces a risk-based approach for comparability assessment, insisting on a statistical approach and a comprehensive study of quality attributes. Special considerations are highlighted for products derived from variable cellular starting material and for tissue-engineered medical products. Due to terminological gaps, the industry must still refer to previous CMC guidance for CGT products and biologics. #FDA #CGT #ManufacturingChanges"

Gene therapies and nanomedicines are revolutionizing the way we approach disease treatment and prevention. The Inside Battelle blog from Anthony Duong explains. #GeneTherapies #Nanomedicine https://okt.to/sTXkwR

Gene therapies and nanomedicines are revolutionizing the way we approach disease treatment and prevention. The Inside Battelle blog from Anthony Duong explains. #GeneTherapies #Nanomedicine https://okt.to/3jc6OM

Gene therapies and nanomedicines are revolutionizing the way we approach disease treatment and prevention. Read more from Anthony Duong Ph.D. as he dives into the convergence of these transformative tools and what to expect from a regulatory perspective. #GeneTherapies #Nanomedicine https://okt.to/AeqsBC

Gene therapies and nanomedicines are revolutionizing the way we approach disease treatment and prevention. Our new blog from Anthony Duong Ph.D. dives into the convergence of these transformative tools and what to expect from a regulatory perspective. #GeneTherapies #Nanomedicine https://okt.to/3tgBdI

Polymerase chain reaction (PCR)-based bioanalytical testing is the cornerstone of evaluating delivery, safety and efficacy of cell and gene therapies. Learn more about reducing regulatory risks in this evolving field. » https://bit.ly/41bblBt #bioanalyticaltesting #cellandgenetherapies #PCRassays

Through fortunate and often dramatic and heartbreaking encounters in my life I learned first hand the life saving value of the cell & gene therapies. This is the reason I am sharing the link to the amazing course run by the talented Melody Janssen. Share this, forward to the people you know who work in this field. It may help them to arrive sooner to the place where more puzzles will be solved and more lives saved. #cell #genetherapy #life #learning #bioanalytics

A new era of personalized medicine is upon us. Gene therapies and nanomedicines are at the forefront of this revolution and are changing how we approach disease treatment and prevention. Read this Inside Battelle blog to get smarter on the subject: https://okt.to/aURTtQ

Gene therapies and nanomedicines are revolutionizing the way we approach disease treatment and prevention. Our new blog from Anthony Duong Ph.D. dives into the convergence of these transformative tools and what to expect from a regulatory perspective. #GeneTherapies #Nanomedicine https://okt.to/KimXzS