02.11.23 -- How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA?
 
Featured Editorial
CGT In 2023 With Cartesian Therapeutics, Poseida Therapeutics, REGENXBIO, And Spark Therapeutics
By Erin Harris, Editor-In-Chief, Cell & Gene
How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA?
By Michael Cooper, Clinical and Regulatory Affairs, Pharmatech Associates
Gene Therapy Remains On Course To Broadly Transform Medicine
By Geoff MacKay, President and CEO, AVROBIO
Astellas Pharma: Moving On From Clinical Hold
By Erin Harris, Editor-In-Chief, Cell & Gene
Industry Insights
Automated Cell Monitoring Through Machine Learning Cell Algorithms
By Yves Daniel and Thomas Guyon
Growing Happy Cells: Bioreactor Optimization
By Anthony Stewart
Manifolding For Scale-Up, Safety, And Speed
By Chris Hofmann and Ian Burdick
Gap Analysis And Collaboration Lead To Clinical Success
By Dawn Niccum
Error-Proofing Single-Use Systems: Three Strategies From Med Device
By Paul Priebe
Novel Ice-Free Cryopreservation For Cell And Gene Therapies
By Gamid Abatchev
Considerations For Media And Mixing
By Ahmed Abouzeid and David Menahem
Improve Sterility Assurance And Data Integrity In A 503B Compounding Pharmacy
By Sheila Dell
Downstream Manufacturing Of Gene Therapy Vectors
Pall Corporation
Streamlining Regulatory Submissions For A Novel Advanced Therapy Medicinal Product Trial
Premier Research
Considerations For Cell Therapy Development And Manufacturing
Applied Biosystems by Thermo Fisher Scientific, qPCR
Has Lentiviral Purification Been Left Behind?
Astrea Bioseparations
What To Consider When Looking To Partner With A CDMO
Andelyn Biosciences
Helping MEARY Center Paris Advance Personalized Medicine
Corning Life Sciences
The Digital Future Is Now
Medable
Maximizing The Project Managers' Sphere Of Influence In Life Sciences
By Patrick Hayes
Innovative Analytical Ultracentrifugation Techniques For The Characterization Of AAV Vectors
By Brianna Barrett, Ph.D., and Julianne Bartz
Multi-Attribute Method (MAM) Solutions For Process And Product Control Of Biotherapeutic Proteins
By Nick Pittman, Magnus Wetterhall, and Scott Berger, Ph.D.
Forge A Successful CRISPR Therapeutic Path With High-Quality GMP sgRNA
Synthego Corporation
Electroporation Made Easy For Hard-To-Transfect Cells
By Sandy Tseng, Anthony Lauer, and Laura Juckem
Enhancing Lentiviral And AAV Transduction Of T Cells
By Mary Doolin, Ph.D., and Jonathan Carson, Ph.D.
Lentiviral Vector Producer Cell Line Generation For CAR T Cell Therapies
By Joana S. Boura, Radmila Todoric, Jordan Wright, Helen Maunder, Laura JE Pearson, Emma Burton, Sara Ferluga, Daniel C. Farley, Kyriacos A. Mitrophanous, Nicholas G. Clarkson, and Hannah J. Stewart
Key Insights Into Overcoming mRNA Process Challenges
Cytiva
Using Next Generation Sequencing Methods For Virus Vector Identity Testing
MilliporeSigma
Expertise, Flexibility In Lipid Nanoparticle Clinical Manufacturing
Evonik Corporation
Combining Cell Clearance And Sterile Filtration Functionality For Improved Clarification Of Mammalian Cell Cultures
Pall Corporation
Common Pitfalls To Avoid When Planning A Marketing Application For Cell And Gene Therapies
Veristat, Inc.
The Journey Into Cell And Gene Therapy
Catalent
2,000-L Scale GMP AAV Manufacturing Process Guidelines Using FectoVIR-AAV
Polyplus
Future Technologies For Cell And Gene Therapy
Precision ADVANCE