While COVID-19 vaccines represent a victory for the scientific community and should be celebrated, we also have a responsibility to educate as many people as we can about their safety and efficacy. ASGCT is doing just that.
- FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch
- Closing Digital Gaps To Unlock The Potential Of The CGT Supply Chain
- Mapping Cell And Gene Therapy Processes: A Common Frame Of Reference For Scientists And Engineers
- C&G Therapy Manufacturing Automation: Making The Most Of Today’s Opportunities
- The Potential of In Vivo Gene Therapy in Rare Pediatric Diseases Like Mucopolysaccharidosis Type II
- Cell and Gene Therapies Are Driving Investment Opportunities
- Philadelphia’s Talent Pipeline Collaborative Readies Region For Cell And Gene Therapy Job Growth
- Future Delivery Models For ATMPs: Practical Considerations
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand
An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.
Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up
In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.
Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness Using “Manufacturing By Design” Methodology
Contract development and manufacturing organizations need to play a critical role in the scale-up and industrialization of cellular therapies by providing customized tools and processes. The Manufacturing by Design approach for addressing the industrialization of cell therapies allows for optimal production conditions.
Bulk Drug Substance Logistics – Primary Packaging
There are currently many options of primary packages on how to transport the drug substance from A to B. This paper explains the benefits and shortcomings of a few of those options.
Best Practices For A Successful Bioprocess Technology Transfer
A well-executed bioprocess technology transfer is critical to ensure smooth knowledge transfer and optimal process reproducibility.
Optimizing Cell Culture Media: Increase Titer With Maintained Protein Quality
When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. Here's how the process improvement can be performed reliably.
How COVID-19 Is Making Operationalizing Gene Therapy Trials Even Tougher – And How We Handled It
The global pandemic has exacerbated the operational challenges intrinsic to gene therapy at the site level, the project team level, and the sponsor level. To ensure that studies continue to move forward, strategies need to be considered not only for operational efficiency and patient centricity but also as contingency planning in the case of a subsequent wave or quarantine. Here we continue our case study of a rescue Phase 1/2 gene therapy trial involving localized administration of gene therapy using specialized equipment with a look at the operational challenges of these trials during COVID-19.
Unravel The Complexity Of Single Cell Natural Killer Cell Cytotoxicity And ADCC Mediation
Current experimental methods to characterize NK cells rely on bulk measurements of heterogenous samples that often contain contaminating cell types. In this application note, we demonstrate how NK cell function can be assessed at the single-cell level to characterize both cytotoxicity and ADCC mediation in the presence of target cells.
Factoring The “What Ifs” Into Supply Forecasting
Growing urgency in the biopharmaceutical industry to speed new products to market leads to greater appreciation for supply forecasting as a strategic and highly complex success factor. Review considerations for developing a supply plan, the influence of early decisions and their impact on outcomes as a trial progresses, and how decisions can put patients and the trial at risk.
LV Scale-Up Workflow In Single-Use Bioreactors For GMP Compliance
Cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.
CELL AND GENE LIVE
In this on-demand webinar Cell & Gene Chief Editor Erin Harris talks with Dr. Mark Gilbert, SVP of R&D at Acepodia, Thomas Lequertier, Head of Cell Therapy Manufacturing Unit at Celyad Oncology, and Luděk Sojka, Ph.D., Chief Technology Officer at SOTIO, about the innovations in manufacturing that can reduce both costs and risks.Cell & Gene Live On-Demand
CELL AND GENE CONTENT COLLECTIONS
Even though cell therapy and gene therapy are overlapping fields of biomedical research, there are differences between them that are germane to each. Cell therapy has challenges and risks all its own. For your reference, here are some of the latest articles that will help you better understand the benefits, risks, costs, and more associated with cell therapy.More Content Collections