Newsletter | February 16, 2021

02.16.21 -- Inside BioCardia's Investigational CardiAMP Cell Therapy For Heart Failure

 
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From The Editor

Greetings Cell & Gene readers,

 

Just recently, I caught up with Peter Altman, Ph.D., CEO at BioCardia, to learn more about the company’s CardiAMP Heart Failure Trial and its best possible outcomes for patients. Here’s what Altman had to say.

 

Dendritic cell (DC)-based therapies have emerged as an exciting avenue of cell-based therapy. This article reviews DC-based therapies in the context of their associated challenges and proposes a future path for DC-based cellular therapy.

 

Erin Harris, editor in chief
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Industry Insights
Addressing The Complexity Of Process Validation For Cell And Gene Therapy Products

The expectation — just as it is with biologics — is that the process is the product. However, cell and gene therapy products have unique features that must be considered during process validation.

Understanding Failure To Ensure Proactive Maintenance

In today’s highly competitive environment, eliminating unplanned downtime is more important than ever, especially when that downtime occurs during a batch that places the product at risk. This article will look at how a greater understanding of failure will help your organization develop the right mindset to achieve “best-in-class” proactive maintenance performance levels.

Supporting AAV And Lentiviral Vector Development And Commercialization

Plasmids are essential for the development of viral vectors used to manufacture novel gene therapies and viral vaccines. We are supporting the innovation of drug developers in this space by providing standardized royalty-free, bulk adeno-associated virus (AAV) helper and lentiviral packaging plasmids for research and GMP production.

8 Ways That Osmolality Testing Improves Cell And Gene Therapy Process Development And Manufacturing

Gene and cell therapies have the potential to revolutionize the treatment of incurable diseases, which are often debilitating, if not fatal. Eight emerging and novel uses for osmolality testing in advanced therapy production are outlined in this white paper.

Utilizing The Multiparameter Capability Of The ZE5 Cell Analyzer To Monitor T-Cell Exhaustion And Effects Of Immunotherapy

When working with limited patient samples, the ability to test multiple parameters simultaneously is highly valuable. This application note reviews how to successfully monitor in-depth changes to the T-cell phenotype, exhaustion, and cellular subset identity markers using a 16-parameter panel developed for use with a five-laser ZE5 Cell Analyzer. Using an in vitro model, they examined T cells before and after chronic stimulation, and in combination with a PD-1 receptor inhibitor, nivolumab.

A Guide To Cleanroom Construction Methodologies

Your future cleanroom is a critical asset; it is not just another construction project. The investment you make in the cleanroom facility is significant, and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.

Establishing Risk-Based Monitoring Within A Quality-Based System As “Best Practice” For Clinical Studies

This report, based on a survey of ACRO members, reveals that risk-based monitoring (RBM) makes clinical trial quality review more efficient and effective. It found that when a company reviews data through a centralized system using the RBM model, CROs and technology companies are better able to detect quality issues earlier and make rapid corrections at the site level. This type of approach is now central to ensuring the safety of patients in clinical trials, and it is expected to continue to grow in importance as clinical trials becomes more numerous and complex.

Radiance Label-Free Monitoring Of AAV Transfection In HEK293 Cells Using Laser Force Cytology

There are several challenges related to the development and manufacturing of adeno-associated virus (AAV)-based processes, including characterization, quantification, and downstream purification. LumaCyte’s Radiance instrument, which uses laser force cytology (LFC) to measure the intrinsic biophysical and biochemical properties of single cells, has the potential to improve the characterization of cell-based AAV transfection and production, improving the efficiency and accuracy of both processes and shortening development time.

The Use Of Robotics In Small-Scale Aseptic Fill/Finish Operations

This presentation addresses the changing needs for the manufacturing of biologics and the rationale for the use of robotics and automation in aseptic fill/finish processing of these products. The webinar covers industry drivers and manufacturing challenges for biologics and provides an introduction to robots and the specific advantages they provide.

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