In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?
- CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward
- 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations
- 6 Key Steps For Cell Therapy Clinical Development Success
- How To Find & Manage Biotech Consultants Effectively
- What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?
- 3 Successful Strategies For Protecting Your New Biopharma’s IP
- How To Advance Continuous Bioprocessing Using Continuous Countercurrent Tangential Chromatography
- Best Practices For Raw Material Supplier Change Notifications: New BioPhorum Guidance
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
Advantages Of Using POD Cleanroom Technology
With recent rapid market growth, demand has increased for flexible alternatives to centralized manufacturing. Having a full-scale GMP facility for each new therapy is implausible yet most facilities are not equipped with the flexibility required to manufacture multiple products. Learn about the advantages of flexible, pre-fabricated modular cleanrooms that are built offsite and delivered as a product to the customer site.
A Model To Increase Yield In mAb Cell Culture Perfusion At Large Scale
As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows.
Efficient Transition Of Human Pluripotent Stem Cell Cultures From Essential 8™ Medium Into NutriStem® hPSC XF Medium On Vitronectin
For clinical translation of hPSCs into cellular therapy, the recommendation is to culture and expand these cells in xeno-free environments that oftentimes utilize recombinant human cell culture substrates like vitronectin. This paper reviews the suggested method for adapting hPSCs originally cultured in E8 on vitronectin to NutriStem® hPSC Medium on vitronectin.
Tangential Flow Filtration (UF/DF) Of Plasmid DNA
Due to their structure, plasmids can sometimes pass through pores that are smaller than their apparent molecular weight. Additionally, the DNA can be shear-sensitive and tends to increase with plasmid size, and the result can be degradation and reduction of the overall yield. Learn how optimization of hydraulic parameters can help you achieve the desired plasmid purity, formulation, and concentration specifications.
Ensuring Provider Education And Readiness For Using A Novel CAR T
A client was launching a novel CAR T-cell therapy in rare hematologic malignancy and needed support to mount an effective launch by mapping the patient journey in this complex CAR T-cell therapy process, identifying the pain points for access to therapy and addressing the educational needs across stakeholders. We were able assist them with a successful launch by designing and implementing comprehensive site training and resources to ensure safe use and patient access.
Use Of Gas Permeable Rapid Expansion (G-Rex®) Culture Ware With Chemically Defined Media For Simplistic And Robust T Lymphocyte Expansion
As immune cell therapies continue to show promising clinical efficacy, advancements in manufacturing platforms must continue in parallel in order to enhance process control, definition, and ultimately, process yield. The single use Gas Permeable Rapid Expansion (G-Rex) vessel offers a practical, robust, and cost-effective solution for immune cell expansion scale up and scale out. In this paper we demonstrate that the chemically defined formulation exhibited robust expansion kinetics of human T cells isolated form peripheral blood of healthy donors in the GRex.
End Of End Point Assays: SPR Analytics In Vaccine Design, Development
Discover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.
2020 Completed Trials: A Bumpy Road for Industry-Sponsored Clinical Studies
The COVID-19 pandemic created delays for trials that were planned for completion in 2020 and directly contributed towards trial terminations. Despite this, more diseases, and more indications outside of oncology, achieved at least 25 successful trials. Read the full report.
Platform Cell And Gene Therapy Media Development
This article highlights a case study on the removal of serum from the expansion step of an autologous cell therapy in a cost-effective manner without affecting cell performance.
Mechanistic Modeling Of Chromatography To Speed Up Process Development
Catch up on the current opportunities and challenges for using mechanistic modeling to simulate and predict chromatographic behavior and experiments in silico.
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
After a decade of painstaking progress, RNA therapies are poised to become a widely applicable approach, as research and engineering efforts have brought the field to clinical reality. Here are some of Cell & Gene’s recent articles that explain not only how far RNA therapies have come, but also their inevitably safe and efficacious future for treating patients.More Content Collections