When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static. Flexible enough to meet the needs of the project and the personnel, this spec will help you create frameworks, master service agreements, and quality agreements for best oversight of your supplier.
- The Expanding Patent Landscape For RNA-Based Therapeutics
- Assessing Quality Of Viral Vectored Vaccines
- India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
- The Future Of Gene Therapy Depends On New Delivery Vehicles
- Cost-Effective Biomanufacturing Of Lentiviral Vectors
- Move Beyond Strength To Motivation
- "Lean On Me": Defining Risk-Sharing In Cell & Gene Therapy Manufacturing Partnerships
- CDMO Selection In Our Post-COVID World
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
Rare Disease Trial Strategies
This white paper focuses on clinical trials, aligning the latest trends in rare disease R&D viewed through the lens of gold-standard clinical intelligence. From this emerges practical recommendations regarding clinical trial design, stakeholder engagement, and patient recruitment.
Quantification Of Large Oligonucleotides Using High Resolution MS/MS
Explore how to achieve sensitive, high-resolution analysis of large oligonucleotides, with the opportunity to perform both qualitative and quantitative analysis in a single run.
Microcarrier Delivery System For Reduced Bioreactor Set Up Time
This paper evaluates a gamma irradiated, ready-to-use microcarrier delivery system that reduced bioreactor set up time by approximately by 20%.
Filling Industry Gaps With Dedicated Cell & Gene Therapy Fluid Transfer Sets
Read how the incorporation of transfer sets designed to support CGTs will aid in the implementation of controllable, consistent, and safe cGMP amenable manufacturing procedures.
Tuning Intermediate Volumes On Sepax™ C-Pro Cell Processing System
Discover how we automate the optimizing cell harvesting process and further minimize the potential for cell loss during wash steps.
Successful Preparation Strategies For NDA/MAA Marketing Applications
No two new drug applications (NDAs) or marketing authorization applications (MAAs) are the same. Learn the key strategies that can be implemented to propel even the most complex submissions to successful regulatory conclusions.
Particulate Contamination Levels In Single-Use Systems
We investigate material adsorption of mRNA-encapsulated lipid nanoparticle (LNP) formulation comparing the Aramus fluoropolymer bag to commonly used glass vials and polypropylene (PP) cryotubes.
Optimization Of AAV Production For High-Yielding And Scalable GMP Processes
By leveraging a standardized, scalable platform approach for viral vector manufacturing, including the transient transfection step, timelines can be accelerated to bring next-generation therapies to market.
Raman vs. MIR Spectroscopy For Mammalian Cell Culture Monitoring
A direct comparison between the two technologies was conducted to investigate which system is more suitable for analyzing mammalian cell culture(s).
Manufacturing Platform & Media Strategy Matters For Mesenchymal Stromal/Stem Cell Production Economics
Biopharmaceuticals need to scale up from laboratory to commercial production at a key point in their development and thus need clearly defined process economics to achieve critical velocity toward commercial success.
CELL AND GENE LIVE
To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy. Check out our latest Cell & Gene Live - now available On-Demand.Cell & Gene Live Archive
CELL AND GENE CONTENT COLLECTIONS
While both allogeneic and autologous therapies use similar technologies common to the growth of cells, the scale is different. In this e-book from Cell & Gene, we've curated insightful editorial that concentrates on the advancements of both allogeneic and autologous therapies and how to manufacture them at scale.More Content Collections