02.18.23 -- How Cell & Gene Therapy Requirements Differ Between FDA & EMA
 
Featured Editorial
How Do Cell And Gene Therapy Requirements Differ Between The FDA And EMA?
By Michael Cooper, Pharmatech Associates
BoB@JPM: Academia To Industry With Oncolytics' Matt Coffey, Ph.D.
Cytiva
The Holistic Guide To Supply Chain For Cell And Gene Therapy Startups
By Janel Firestein and Linda Plumley, Clarkston Consulting
Bench To Boardroom: A Scientist-Turned-CEO’s Journey
By Matthew Pillar, Editor, Bioprocess Online
FDA Submission Automation: Coming To A Cloud Near You
By Matthew Pillar, Editor, Bioprocess Online
Considerations For Sterility Test Methods When Working With CDMOs
By Miriam Guest, principal microbiologist, AstraZeneca
Industry Insights
Amgen's Solution For Antibody Discovery, Cell Line Development
Berkeley Lights
Comparing Vial Container Closure Systems
By Anthony Bucci, Ph.D.
Single Cell Deposition Efficiency
bio-techne
Maintaining Cold Chain At Ultra-Low Temperatures
By Mike Marciniak
Large-Scale AAV Manufacturing: From Concept To Ready-To-Use Platform
AGC Biologics
AAV Production In A Single-Use Bioreactor
Thermo Fisher Scientific
3 Important Developments In Aseptic Connection Technology
CPC
How Do We Quantify Continuous Manufacturing Benefits?
Sartorius
Boost Performance With A Chromatography Resin Update
Cytiva
Developing Lifesaving Medicines Through Cell Culture Technologies
Evonik Corporation
Biopharmaceutical Manufacturing: Why Australia?
AcuraBio
Align CMC Strategy With Clinical Path Requirements And Timelines
By Lee Allen and Megan Mason
CDMO Collaboration: Foundation For Sterile Injectable Product Success
Pfizer CentreOne
Early Plasmid Optimization For Long-Term Commercial Success
By Kristin Heller and Andy Moreo
Gamma, Ebeam, Or X-Ray? The Future Of Radiation Sterilization
By Paul Priebe
The Raw Material Hurdle: Plasmids For Viral Vector-Based Gene Therapies
By Thomas VanCott, Ph.D.
Advances In mAb Purification
Purolite, An Ecolab Company
Developing Cost-Effective, Accelerated Downstream Processes
Astrea Bioseparations
Mechanistic Modeling: Digital Twins Are Here To Stay
By Tobias Hahn
Your Capital Equipment Project Is Cancelled — Now What?
By Matt Hicks
Navigate Complex Ancillary Supply Sourcing Challenges
By Tim Brewer
Oligonucleotide Development And Manufacturing Workflow
Cytiva
Is Your API Ready For Scale-Up? What To Demand From Your CDMO
By Justin A. Divan
How To Automate Continued Process Verification
MilliporeSigma
5,000 L Single-Use Bioreactors: Next-Gen Biologics Manufacturing
By Preeti Phanse, Mark Smith, Ph.D., et al.
Optimizing A Perfusion Manufacturing Process For Commercial Production
AGC Biologics
Improved Total Lentiviral Titer And Quality With A Perfusion-Based System
By Carol Knevelman
Automated High-Throughput Osmolality Testing With Precision And Accuracy
By Emily Hyatt, Nancy Perlmutter, et al.
Dual Sourcing To Help Mitigate Risk In The Supply Chain
PCI Pharma Services
Development, Manufacture Of Biopharmaceuticals In Microbial Systems
Lonza
CQV Strategies To Optimize Cell Therapy Manufacturing
Project Farma
Next-Gen Cell Therapies Need Next-Gen Cell Counters
By Steve Wiltgen, Ph.D.
Intensification Strategies For Upstream, Downstream Processes
Cytiva
HCP Immunoassay Qualification: Review Of Orthogonal Methods
Cygnus Technologies Inc.
It's About Time! Automate Biomolecule LC-MS Spectral Deconvolution
By Scott Berger and Patrick Boyce
Outsourced Bioprocessing By Respondent Location
ISR Reports
Top Four Considerations For Tech Transfer Performance
By Lei Zheng
Low-Volume Production For Screening High-Value Nanoparticle Materials
By Chelsea Cayabyab, Andrew Brown, et al.
Cost-Efficient Biosimilar Purification Using Ion Exchange Resins
By Drs. Randy Drevland, Chelsea Pratt, et al.