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Scaling Non-Viral Gene Delivery: Lonza’s LV PRO Breakthrough in T Cell Manufacturing
Published on Lonza Poster Presentation (CT-PO024) Non-viral electroporation continues to gain ground as a safer, scalable alternative to...
Jun 13
New FDA Designation Approves First AMT Program
Published on Cell & Gene The U.S. FDA has approved the first product under its new Advanced Manufacturing Technology (AMT) designation, a...
Jun 9
Future-Proofing Gene Therapy Assay Validation: Key Strategies
Published on Cell & Gene As gene therapy evolves, so must the validation strategies behind its assays. This article outlines...
Jun 9
Navigating Global Biopharma Regulations in a Rapidly Changing Industry
Published on Cell & Gene Global regulatory requirements are evolving fast, especially in cell and gene therapy. This article outlines...
Jun 9
Traceable Workflows for Faster, Compliant Clinical Data Review
Published on Cell & Gene Speed and transparency in clinical data review are vital for regulatory approval. This article looks at how...
Jun 9
Navigating Cell Therapy Categorization in Regulatory Frameworks
Published on Cell & Gene Cell therapy products often sit in regulatory gray zones due to their complex nature. This article explores how...
Jun 9
EU Annex 1: Strengthening Contamination Control in Cleanroom Practices
Published on Cell & Gene With updates to EU Annex 1, contamination control strategy (CCS) is now a central part of regulatory...
Jun 9
Managing Extractables & Leachables: Early Planning with Your CDMO
Published on Cell & Gene Extractables and leachables (E&L) testing is a critical regulatory expectation in cell and gene therapy...
Jun 9
Mobile Gowning Cleanroom Meets ISO 7 Standards
Published on Cell & Gene Regeneron has introduced a cGMP-compliant mobile gowning cleanroom built to meet ISO 7 standards. This setup...
Jun 9
Reducing FDA Form 483 Risks with Modular Cleanrooms
Published on Cell & Gene Facility design plays a major role in compliance. This article discusses how modular cleanrooms can help reduce...
Jun 9
Key Challenges in Gene Therapy Testing: Regulatory Considerations
Published on Cell & Gene Testing gene therapy products involves unique technical and regulatory hurdles. This article outlines four key...
Jun 9
Femtobiomed Showcases GMP-Ready Cell Therapy Advances
Published on Cell & Gene At the recent Cell & Gene Tech Expo, Femtobiomed Inc. presented its latest work in cellular immunotherapies with...
Jun 9
Cleanroom Compliance: 3-Bucket Mopping System Protocol
Published on Cell & Gene Maintaining cleanroom standards is a key part of regulatory compliance in cell and gene therapy facilities. ...
Jun 9
One-of-One CRISPR: How Scientists Saved a Baby with Personalized Gene Editing
Published on Spencer Knight via LinkedIn A landmark case in gene-editing has just unfolded: baby KJ, only nine months old and suffering...
May 17
NEJM: First In Vivo Base Editing Therapy for Infant With Rare Genetic Disorder
Published on New England Journal of Medicine (May 15, 2025) A nine-month-old patient with fatal CPS1 deficiency has become the first...
May 17
SSCTR President Highlights International Engagement in Cell and Gene Therapy
The Sarawak Society for Cell & Gene Therapy Research (SSCTR) proudly shares the recent international participation of its President, who...
May 16
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