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Automating Non-Viral Cell Therapy Manufacturing: Cocoon® Meets Nucleofector®
Published on Lonza White Paper (CT-SP008) Cell therapy manufacturing is often held back by viral vector limitations and labor-intensive...
Jun 13, 2025


How Large-Volume Electroporation Is Powering the Next Phase of Cell Therapy
Published on Lonza Overview (CT-SP019) Scaling cell therapy from benchtop to bedside requires technologies that are efficient, compliant,...
Jun 13, 2025


Expanding Gamma Delta T Cells: Two Scalable Methods Shaping Cell Therapy
Published on Lonza Poster Presentation (CT-SP020) Gamma delta (γδ) T cells are gaining momentum as a promising cell therapy platform due...
Jun 13, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025


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, 2025
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