
The Dish’s Weekly Biotechnology News Wrap Up – February 3, 2017
This week’s headlines include: Johnson & Johnson refills drug cabinet with $30 billion Actelion deal, Chasing Sanofi, Pfizer tees up phase 3 trials for C. diff vaccine, Eight medicines leap towards EU approval, Novartis says Votubia receives EU approval for new indication, Calithera and Incyte Agree on $53M Up-Front Deal for Clinical-Stage Arginase Inhibitor, and European Commission Offers New Q&A on Biosimilars.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Filling Industry Gaps with Dedicated Cell Therapy Fluid Transfer Sets
Cell therapies have the promise and potential to not only treat, but potentially cure disease. Rapid growth in the Cell Therapy industry is driving demand in cellular manufacturing, and with that comes the increased need for quality, scalable components, and products to support the clinical and commercial therapeutic pipeline (1). While a wide variety of ancillary products, including single-use disposables, exist to support the Cell Therapy industry. Many have been designed for other industries and purposes resulting in Cell Therapy manufacturers having to adapt to pre-existing processes (2). Given the critical limitations that come with many autologous cell-based therapies, it is important to provide and implement products that will help to enhance quality, safety, and commercial viability…Cell Culture Monitoring – A Critical Component for Quality by Design in Cell Therapy
Cell therapies offer much promise in treating a range of medical conditions, but manufacturing complexity is a challenge when scaling up to clinical and commercial manufacturing. Concerns include developing a process that is efficient and cost effective with consistent, high quality outcomes…The Top 15 Cell Culture Dish Cool Tools Features in 2016
I have compiled a list of our most popular Cool Tools Features for 2016. Here are the top 15 in alphabetical order…The Top 30 Cell Culture Dish Blogs of 2016
I have compiled a list of our most popular 30 Blogs for 2016. Here are the top Cell Culture Dish blogs in alphabetical order…Increasing Downstream Bioprocess Efficiency and Overcoming Bottlenecks
In a recent white paper, the issue of improving downstream efficiency was explored. The paper, “Unlocking the Potential for Efficiency in Downstream Bioprocess,” published by GE Healthcare Life Sciences, described techniques like continuous processing, in-line conditioning buffer preparation, and system automation as tools to improve the overall efficiency of downstream processes while at the same time eliminating bottlenecks and facility fit issues. I have summarized the highlights of the paper in this article. Biomanufacturing is constantly evolving due to changing industry demands and new technologies that enable advancement. Industry goals are now primarily focused on reducing cost and improving throughput, productivity, time to market and flexibility. These goals must be met whilst maintaining the highest levels of product quality and safety requirements. With increased titer, downstream processes have had to manage higher titers and greater impurities than they were originally designed for. Thus downstream processes must also be improved to create an entire manufacturing process that is more streamlined and meets industry goals… The use of Protein A affinity chromatography is commonplace in biopharmaceutical manufacturing, with 95% of all commercially available MAbs using Protein A purification. High purity is achieved in one step (around 99%), but it is well recognized that the cost of Protein A resins is substantial. If a product makes it to marketing approval and manufacturing these costs are amortized over a large number of purification cycles and the contribution to cost of goods is acceptable. However, a high percentage of clinical projects will fail, resulting in the Protein A resin only being used for a small number of cycles – significantly reducing cost-efficiencies…Affordable Biologic Downstream Purification with Single-Use Protein A Membrane
At this year’s Boston Biotech Week there were many exciting talks on downstream purification and associated new technologies. In particular, there were several talks about optimizing the downstream purification process. One very interesting talk, given by Renaud Jacquemart, PhD Principal Scientist, Director Vaccines Process Sciences, was titled “Enabling Manufacturing Of Affordable Biologics Through The Use Of A Protein A Membrane In A Single-Use Purification Strategy ” and focused on the application of a fully single-use chromatography purification process in place of resins. This strategy envisions the use of a unique Protein A membrane for which Natrix recently signed collaboration agreements with Merck & Co. and Sanofi…
The Top 10 Downstream Column Blogs in 2016
I have compiled a list of our most popular 10 Blogs for 2016. Here are the top Downstream Column blogs in alphabetical order…