The Dish’s Weekly Biotechnology News Wrap Up – June 7, 2019
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In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Novel Acoustic Platform Provides Gentler, More Efficient Solution for Cell Processing
Cell and gene therapies are in need of evolving manufacturing technologies to move products from research, through development and into, commercial manufacturing. As more cell and gene therapy products achieve clinical success, more investments are being made in creating manufacturing technologies to support the industry. There are several advancements in this area including the closing and automating of many manufacturing processes and increasing efficiencies with the creation of fit for purpose equipment and consumables. There are still, however, many needed improvements to further increase productivity and reduce cost…Rapid Mycoplasma Testing for Biomanufacturing Applications
Increasingly the quality of raw materials used in cell culture media and supplements is being closely examined for any potential negative impact on cell culture or the final product quality. One area of concern is biomanufacturing contamination. While there are certainly many possible entry points for cell culture contamination, contaminated raw materials is high on the list. Of the possible contaminants, mycoplasma is often a big concern because it is fairly resilient in laboratory environments, resistant to most, if not all antibiotics, and also contamination in culture is not always obvious. Yet, mycoplasma contamination can have a devastating impact on biopharmaceutical development and production. As a result, having adequate mycoplasma monitoring in place is critical for minimizing the risk and ultimately impact of contamination…Optimizing Fed Batch Culture – Developing New Tools and Methods to Improve Production
The past decade has seen a surge in the development of gene therapies. Currently there are over 1,000 cell and gene therapy clinical trials underway worldwide.1 While the majority of current trials are still in Phase I or Phase II, there are more than 90 trials in Phase III. In fact, at last year’s BIO International Convention, Scott Gottlieb, Commissioner of the US Food and Drug Administration (FDA) stated that he expects the FDA to approve 40 gene therapies by 2022.2…Transfection Reagent Portfolio Enables Seamless Scalability from R&D to Commercial Therapeutic Viral Vector Manufacturing
One common challenge in viral vector production is transitioning from research-based production to more rigorous quality and safety profiles for clinical and commercial manufacture. In fact, raw materials used in production at research scale are often not cGMP-compliant and therefore fit for clinical or commercial manufacturing. This means that critical raw materials frequently need to be replaced with cGMP grade material sourced from approved suppliers during process scale up. cGMP grade materials are manufactured under strict conditions and must pass rigorous testing. This higher manufacturing standard reduces the risk of introducing adventitious agents into clinical and commercial viral vector manufacturing…Spheroid Cell Culture – Practical solutions for frequently asked questions
The past decade has seen an increase in publications recognizing the value of culturing cells in three dimensions (3D) and the use of these 3D cell culture models has shown utility in many areas of research from cancer biology to regenerative medicine. One of the most common 3D cell culture types is spheroids. Spheroids more accurately recapitulate the native in vivo microenvironment with respect to cellular function and response to drugs than more traditional two-dimensional (2D) models. That said, working with spheroids is not without its challenges. Many labs working with spheroids have run into technical hurdles incorporating them into existing cell culture workflows. Whether it is issues with handling or optimizing protocols to assaying cells in 3D, these obstacles can be overcome…