Site feasibility assessment can be challenging. Therefore, it’s essential to have a solid understanding of the regulatory obligations for investigators and sites when it comes to choosing each.
- Huh? Where Did That Environmental Monitoring Hit Come From?
- A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
- FDA’s CBER Issues Final Guidance For CAR T Cell Products
- Inside Yescarta's Reduced Median Turnaround Time With Kite Pharma's Christopher McDonald
- New DSCSA Guidance Details Layers Of Verification System Requirements
- Using Relational Risk Analysis To Control Procedure Failures In The Bio/Pharma & Medical Device Industry
- Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
- Trends In FDA FY2023 Inspection-Based Warning Letters
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
The Journey To AAV Production In Suspension – Scaling-Up Your Process
We present a simple protocol for scaling up AAV production using HEK293 host cells cultured in suspension and under serum-free conditions.
Transfection Reagents For Scalable Virus Production
Why is this transfection reagent often chosen for virus production runs in the most adherent and suspension cell culture systems and what are it's benefits?
Released N-Linked Glycan Analysis
Review a streamlined N-linked glycan analysis that employs an automated sample preparation with the magnetic bead-mediated glycan workflow followed by capillary electrophoresis.
AAV Full/Empty Capsid Separation Using Mechanistic Modeling
In this study, we used mechanistic modeling to investigate how AAV-resin interactions are affected when MgCl2 is used as an elution additive.
Rare Disease – 2018-2022 Global Clinical Trial Landscape
Discover why the collaboration and expertise of organizations are vital in advancing rare disease research and improving the lives of millions affected.
Expert Consulting, MRCT Strategy Rescues Oncology Program
Uncover how teams identified missing IB data and necessary additional details needed to outline U.S. study challenges as required for local authority approval in a previously failing study.
The Power Of Modular Design
Learn how modular design has the potential to provide a solution for the increasing pressure and demand for biologics.
Key Stages In mRNA-Based Therapeutic Development
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
Cell Harvesting: Optimizing Viability And Recovery In Cell Therapy
Learn about a family of centrifuges and review of data collected on the centrifuges' performance for the harvest of cells in cell therapy production.
Quantify Secreted T Cell Activation Markers
Learn how to achieve a rapid and precise assessment of secreted T cell activation markers to boost cell therapy development and manufacturing efficiency.
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