Newsletter | September 15, 2020

09.15.20 -- How Obsidian Therapeutics Overcame Disruptions Due To COVID-19

 
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From The Editor

Greetings Cell & Gene readers,

 

In part two of this three-part series, the future of regenerative medicine explores how 3D bioprinting will potentially save the lives of millions of patients awaiting lung transplants. In case you missed it, part one discussed regenerative medicine’s impact on 3D printing of human hearts.

 

Here’s how Obsidian Therapeutics' CEO, Dr. Paul Wotton, developed a novel solution to the workforce and resource disruption caused by COVID-19 social distancing restrictions. He’s made it available to other biotechs, free of charge.

 

Erin Harris, editor in chief
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Industry Insights
Using Preamplification To Maximize qPCR Data From Limited Samples

Preamplification is frequently treated as a necessary evil, as many fear that it may introduce bias into their experiments, leading to the generation of inaccurate results. Preamplification is also sometimes misunderstood as being a magic bullet to boost quantitative polymerase chain reaction (qPCR) sensitivity. This article addresses these issues, as well as others, so that you can be confident when using preamplification in your qPCR experiments.

Is Not Using A CDMO Slowing Down Your Process Development?

Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.

Transitioning To A New Biobank Model At A Time Of Change

To meet the increased demand for rapid access to high-quality samples, the AstraZeneca UK Biobank partnered with Fisher Clinical Services to create a mixed outsourcing biobank model.

How To Implement Cleanroom Upgrades While Operating Your Facility

It goes without saying that upgrades during a manufacturing shutdown pose less risk, as there are no products being produced, but there are instances when it is critical to expand capacity or modify functionality while maintaining some processing. Following are steps to help maintain control of production and changes — and demonstrate proof of control — while keeping the involved workers and the products safe.

First-In-Human Trials: A Make-Or-Break Milestone For Small Biopharmas

Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into first-in-human (FIH) testing is essential. But, how?

Optimization, Validation, And Implementation Of Retroviral Retentive Filters For Production Of Adeno-Associated Virus (AAV)

Viral contamination is a risk for all biotechnology products. Establishing robust viral removal/inactivation steps mitigates the risk of adventitious and endogenous viral contamination and is essential for ensuring the safety of gene therapy products. Recent studies have shown that viral retentive filtration is one of the most robust steps in removing all types of viruses. In this study, we focused on the initial development process of the retroviral-retentive Viresolve NFR filter.

Quantifying Viruses? Here’s What Matters Most

With viruses playing a greater role in everything from vaccine development to gene therapy, ensuring their rapid, accurate, and biologically relevant enumeration isn’t just an analytical “plus;” it’s the first step in the development of biological tools that support human health. Seeing the potential in this emerging technology — called the Virus Counter platform — Sartorius Stedim Biotech acquired it in 2016 and made it even better, engineering it into a robust commercial platform. In this Q&A, Antje Schickert, product manager for virus analytics at Sartorius Stedim Biotech, explains how the Virus Counter makes even the trickiest virus enumerations …well, count.

Overcoming Commercialization Challenges For Cell And Gene Therapies

The early promise offered by cell therapies and gene therapies is tempered by the challenges associated with developing, manufacturing, and delivering the drug product to patients. This panel discussion highlights technical and regulatory hurdles associated with development and manufacturing steps, and strategies and solutions to facilitate development through commercialization.

How To Optimize The Stability And Solubility Of Media Ingredients To Improve The Performance Of Cell Culture Media And Processes

The cell culture media used in biopharmaceutical production have come a long way over the last few decades. Arguably the single biggest change has been the shift from complex animal-derived compositions to chemically defined media that are safer, more consistent, and deliver higher levels of performance. This interview discusses key solubility, stability, and other challenges that still face many media developers and biopharma companies.

Single-Use Technologies For BDS Freeze/Ship/Thaw

Mike Johnson, Johannes Kirchmair (SUS), explains the importance of having a complete, cold-resistant solution of bags, tubing, connectors, and shells.

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