Newsletter | June 16, 2020

06.16.20 -- Dendritic Cells For Cancer Treatment: Future Therapeutic Avenues

 
Sponsor
From The Editor

Greetings Cell & Gene readers,

 

Dendritic cell (DC)-based therapies have emerged as an exciting avenue of cell-based therapy due to their unique function as antigen presenting cells (APCs) and subsequent ability to activate T cells with antitumorigenic effect. This article reviews DC-based therapies in the context of their associated challenges and proposes a future path.

 

Dr. Haro Hartounian of the New Jersey Innovation Institute was tasked with leveraging the vast resources of the university to help advance the biopharma industry and bring more regenerative medicines to market. Here is how he uncovered manufacturing challenges and the steps they are taking to fuel advancements.

 

Erin Harris, editor in chief
Follow me on Twitter

Industry Insights
The Pivotal Role Of Standardization In FFPE Tissue Block Collection

Given the significant potential of formalin-fixed paraffin-embedding (FFPE) tissues, this material must be collected, documented, and preserved properly in order to gain its full potential.

Developing A New Biologics Drug: Regulatory Challenges And Considerations

The journey from research lab to market is a long one, and most drug candidates do not make it. Following are some tips to assist with up-front planning to prevent headaches down the road.

Statistical Considerations In The Wake Of COVID-19

COVID-19 has dramatically changed the way we conduct clinical trials and left many sponsors without answers when it comes to the future of their studies. This podcast explores challenges sponsors see as a result of this crisis, the impact those challenges are having on trial procedures, and how modifications to the statistical analysis plan can point a path forward.

Tufts Study: Advantages Of Single-Source Drug Development, Manufacturing

A recent study by the Tufts Center for the Study of Drug Development (CSDD) compared cycle times and development economics between multi- and single-source CDMO models.

Induced Pluripotent Stem Cells In Cell And Gene Therapy: Part 1 — Understanding Reprogramming
Reprogramming induced pluripotent stem cells (iPSCs) remains an open and manual process, carried out using conventional basic research techniques. To advance cell and gene therapy (CGT) and to get products derived from iPSCs to the clinic, generation and maintenance of cells for therapeutics in a good manufacturing practices (GMP) setting becomes paramount. So, how is this achieved?
How To Overcome Validation Challenges In A Single-Use World

How can end users ensure the expected level of compliance in this new world of single-use systems? The secret: shared responsibility for validation with your supply chain.

Risk Mitigation Strategies For Raw And Starting Materials Used In Gene Therapies

Recently approved cell and gene therapies are delivering impressive results for patients who otherwise have exhausted all treatment options or have had no options available to them. However, manufacturers are faced with many challenges in the journey from development to commercialization. Within this challenging environment, a number of risk mitigation strategies related to the materials used to produce viral vectors can be employed to help accelerate progress toward commercialization of these remarkable therapeutics.

Case Studies In Supply Chain Management: Getting It Right From The Start

Consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. In this article we’ll review two case studies that demonstrate the importance of supply chain management by focusing on scaling up for commercial distribution and on packaging challenges within a cryogenic environment.

Solutions