In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- Enhancing Gene And Cell Therapies With Circular RNA-Based Gene Expression
- FDA Explains How To Respond To Form 483 Observations In New Draft Guidance
- Organizing Digital Systems Around Novel Modalities
- Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures
- Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains
- PUPSIT In Cell & Gene Therapy: Risk Reduction Or Operational Complexity?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-2196950201-scientists-chromatography-system-training]( "Process Intensification Through Downstream Connectivity")
Process Intensification Through Downstream ConnectivitySee how downstream steps can be linked into a coordinated workflow, with practical insight into automation, equipment integration, and process control for building a more efficient strategy.
-
![GettyImages-597971944-viral-vector-AAV-adeno-associated-virus]( "The Key To Viral Vector Success")
The Key To Viral Vector SuccessEstablishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
-
![GettyImages-2203738408-computer-monitor-screen-gene-editing-lab-woman]( "12.5x Titer Boost Accelerates CAR-T Program To IND Filing")
12.5x Titer Boost Accelerates CAR-T Program To IND FilingPlasmid engineering and process development boosted viral titer 12.5×, eliminating manufacturing bottlenecks and enabling an on‑time regulatory submission for the cell therapy program.
-
![Pharmaceutical bioreactor-GettyImages-836094936]( "Expansion Of Cord Blood-Derived CD34+ Cells In A Hollow-Fiber Bioreactor With 10% Standard Cytokine Concentration")
Expansion Of Cord Blood-Derived CD34+ Cells In A Hollow-Fiber Bioreactor With 10% Standard Cytokine ConcentrationCD34+ cells isolated from cord blood were expanded in a hollow-fiber bioreactor using a novel cytokine cocktail at one-tenth the standard concentration using a MSC-free coating strategy.
-
![long-read-seq-NSF-Belgium-agilent]( "Advancing Genomic Discoveries With Comprehensive Sequencing Support")
Advancing Genomic Discoveries With Comprehensive Sequencing SupportSee how a leading genomics facility advances long‑read sequencing through rigorous QC and flexible workflows, offering practical insights for researchers aiming to improve sequencing outcomes.
-
![GettyImages-2166551611 ddPCR]( "Improving Next-Generation Sequencing Workflows With Droplet Digital PCR")
Improving Next-Generation Sequencing Workflows With Droplet Digital PCROptimize NGS workflows by using digital PCR for absolute quantification. Improve library quality, reduce bias, and gain sensitive validation for rare variants in complex genomic samples.
-
![BioPhorum]( "Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration")
Handle Single-Use Technology Biopharma Waste: Data Sharing, CollaborationLearn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.
-
![Emulate Liver Chip]( "A Human-Relevant Model Of The Liver Sinusoid")
A Human-Relevant Model Of The Liver SinusoidThis organ-on-a-chip model minimizes drug absorption while maintaining the essential architecture. Explore the specifications of this product engineered to model the human liver.
-
![GettyImages-1067806062-scientist-lab-vaccine-vial]( "Advancing Dose Escalation Strategies With Bayesian Modeling")
Advancing Dose Escalation Strategies With Bayesian ModelingA CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.
-
![GettyImages-1500981700 cell culture]( "Automated DNA Clean-Up Using Magnetic Bead-Based Methods")
Automated DNA Clean-Up Using Magnetic Bead-Based MethodsDiscover how to improve DNA clean‑up through a precise magnetic bead–based workflow, as well as how optimized liquid handling enhances yield, purity, and reproducibility for higher confidence in results.
NEWSLETTER ARCHIVE
- 07.07.26 -- Targeting Tau In Alzheimer's Disease With Voyager Therapeutics' Al Sandrock, M.D., Ph.D.
- 07.07.26 -- AI Has Arrived In Biotech CMC Amid Patchwork Governance
- 07.06.26 -- In An Era Of Overcapacity, Should Companies Rent, Lease, Or Build Their Manufacturing Future?
- 07.03.26 -- Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains
- 07.02.26 -- New Podcast Episodes: A Midyear Look At Life Sciences, Derisking CNS Drug Development, In Vivo Gene Editing
- How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale
- In Vivo Gene Editing Is Moving From Promise To Proof
- Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT
- CGT Manufacturing Shifts From Capacity To Strategy
- Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook
CELL AND GENE CONTENT COLLECTIONS
While there are opportunities to scale, there are also manufacturing gaps, capacity issues, and production timelines that require improvement to do so. And then, of course, there’s cost. Because scale up and scale out are significant to everyone in the sector, we’ve curated insightful editorial that addresses the most important aspects of scalability.
More Content Collections
