This week’s headlines include: Tumor ‘vaccine’ clears several cancer types in mice, Amazon Wants to Disrupt Health Care in America. In China, Tech Giants Already Have, Newly Named Pall Biotech Business Unit Focuses on Flexible, Scalable End-to-End Drug Manufacturing Models for All Development Processes, Biobanking for “All of Us”, RoosterBio Commercializes Industry’s First cGMP Human Mesenchymal Stem Cell Banks For Widespread Manufacturing, Continuing To Revolutionize Regenerative Medicine, and Is Drinking Healthy? Alcohol Helps Clean Toxins From the Brain, Study Shows.

In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

See the quality of your viral particles at different steps of your process

In Gene Therapy, viral vector stability and integrity must be carefully investigated before scaling up production. Specific process steps can be evaluated to understand what impact they have on viral particle integrity. Viral particle characterization is vital during process development, to ensure final product quality…

The Top 30 Cell Culture Dish Blogs of 2017

I have compiled a list of our most popular 30 Blogs for 2017. Here are the top Cell Culture Dish blogs in alphabetical order…

Scale-Out Biomanufacturing – A Paradigm Change to Scale Up

In biomanufacturing, a production scale change is required to either meet the market growth demand or when a product moves from clinical to commercial manufacturing. How that volume is increased depends on whether a scale up or scale out philosophy is used. The industry standard has been to scale up, which translates to increasing the size of the bioreactors used in manufacturing runs. However, due to the recent availability and ease of single-use technologies, coupled with improvements in cell culture productivity; scale out may soon create a shift in the way biologics are manufactured…

Ask the Expert – Cancer Research

Unlocking the complexities of cancer is an ongoing challenge. Luckily, a countless number of researchers are working every day – determined to understand the causes and behaviors of cancer in search of new and better ways to more effectively treat the disease…

Addressing Challenges in Downstream Biomanufacturing with a platform purification approach

In this podcast and accompanying article, we interviewed Jonathan Royce, Business Leader, Chromatography Resins, GE Healthcare Life Sciences, about the biggest challenges in Downstream biomanufacturing including overcoming bottlenecks, changing antibody structures and bioburden control. Jonathan shared how a purification platform can address some of these issues and discusses purification challenges that still need to be resolved.

The Top 25 Downstream Column Blogs of 2017

I have compiled a list of our most popular 25 blogs, podcasts, and webinars for 2017 listed in alphabetical order…

Protein A Chromatography – A look at where we have been and where we are going

In this podcast and accompanying article, we interviewed Jonathan Royce,  Business Leader, Chromatography Resins, GE Healthcare Life Sciences, about the evolution of Protein A including the latest developments in Protein A chromatography resins. We also discussed what the future holds for this purification mainstay and how it can continue to address the changing needs of biopharma…

Downstream Bioprocessing Cost Modeling – Looking at Integrated Continuous, Single-use and Stainless Steel Platforms

Process economics are frequently discussed with respect to continuous biomanufacturing implementation. More specifically, are the potential cost benefits worth making a manufacturing change and in which situations are the benefits greatest? At Biotech Week Boston in September, there was a very interesting talk titled “Cost modeling of the downstream bioprocessing design space,” presented by Mark Schofield, Ph.D., Senior R&D Manager, Pall Life Sciences. In the talk, Dr. Schofield shows data related to cost modeling the downstream bioprocess design space. He also describes some of the challenges facing biomanufacturing including cost pressure, competition, and the rise of biosimilars, and how implementing integrated continuous operations can address several of these challenges…

Webinars:

The Process Economics of Continuous Downstream Bioprocessing

New Webinar Available On Demand!

The cost of goods of an Integrated Continuous Bioprocessing (ICB) platform for the manufacturing of a mAb from fed-batch cell harvest has been evaluated using BioSolve Process, a modeling software from BioPharm Services. The costs associated with the ICB platform were compared to those of stainless steel and single-use batch processes. These downstream processes were evaluated across sets of clinical and commercial production scenarios. For both sets of scenarios, 27 different cases were modeled by varying 3 factors: bioreactor titer, volume, and number of batches per year. By taking this approach, the cost-benefits of the ICB platform could be seen across a wide range of manufacturing scales.

In this webinar, participants will learn:

• The findings of the full-factorial modeling exercise.
• The cost-benefits of continuous bioprocessing at many scales of manufacturing.

Podcasts:

Check out our podcast channel. We have 15 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more!

Click below to download through iTunes or Google play:

Headlines:

“Amazon Wants to Disrupt Health Care in America. In China, Tech Giants Already Have,” The New York Times

“Amazon and two other American titans are trying to shake up health care by experimenting with their own employees’ coverage. By Chinese standards, they’re behind the curve…”

“Newly Named Pall Biotech Business Unit Focuses on Flexible, Scalable End-to-End Drug Manufacturing Models for All Development Processes,” PR Newswire

“Pall Corporation, a global leader in filtration, separation and purification, has a newly named business unit within the Pall Life Sciences division. The Pall Biotech business unit has been named to reflect an important strategic direction for the company. The update will not impact current or prospective company operations…”

“Biobanking for “All of Us”, Genetic Engineering News

“The Precision Medicine Initiative (PMI) was created by the NIH to answer broad questions on a scale that might be missed by more specialized cohort collections. The production of highly diverse libraries, on a population-wide scale of tens to hundreds of millions of samples, will drive medical understanding by …”

“RoosterBio Commercializes Industry’s First cGMP Human Mesenchymal Stem Cell Banks For Widespread Manufacturing, Continuing To Revolutionize Regenerative Medicine,” PRWeb

“RoosterBio.com, a leading manufacturer of adult, allogeneic human mesenchymal stem/stromal cells (hMSCs) and paired bioprocess media systems, continues to deliver on its mission to de-bottleneck and accelerate the Regenerative Medicine Industry by launching the only commercially-available working cell banks (WCBs) for large scale hMSC production. Introduced under the CliniControlTM Brand Name, these hMSC WCBs are manufactured to current Good Manufacturing Practices (cGMP) and conform to xeno-free (XF) guidelines, as outlined by the International Society for Cellular Therapies. CliniControl™ hMSCs are supported for use as a cellular starting material for therapeutic cell manufacturing by Quality and Regulatory documentation, which facilitates IND filings…”

“Is Drinking Healthy? Alcohol Helps Clean Toxins From the Brain, Study Shows,” Newsweek

“A little bit of alcohol might help your brain clean itself, new research published Friday in Scientific Reports suggests. The research was done in mice, so it’s impossible to say if the benefit is the same for humans. But still.  We already knew that alcohol has some health benefits, Dr. Maiken Nedergaard told Newsweek. “Except for a few types of cancer, including unfortunately breast cancer, alcohol is good for almost everything,” said Nedergaard, the director of the Center for Translational Neuromedicine at the University of Rochester Medical Center.”