The Dish’s Weekly Biotechnology News Wrap Up – February 24, 2017
This week’s headlines include: BrainStorm seeks early approval for stem cell treatment in Canada, Gates Foundation boosts UCSD-led malaria research, Biosimilar Inflectra matches Remicade efficacy in trial, and New culture method boosts T cells’ ability to recognize multiple cancers.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Going to BPI West 2017? Don’t miss these great talks and activities!
BPI West 2017 begins February 27th in San Francisco. The conference is focused on providing companies the opportunity to share ideas, strategies and solutions to overcome challenges at every stage of development. Cell Culture Dish/Downstream Column will be attending and blogging from the event. Please don’t miss our BPI West related blogs over the next month. If you are attending, don’t miss these exciting talks and activities! Gene therapies and immunotherapies hold tremendous promise to treat diseases in a completely novel way. As increasing numbers of these therapies move from research and proof of concept to clinical trials, the manufacturing requirements will become more complex. Part of this includes a desire to move away from media that contain animal-derived and undefined components to animal component-free and chemically-defined components. In addition to the possible safety issues, animal components can be variable from lot to lot. Animal components with their naturally occurring cytokines and growth factors can also result in undesired and unexpected effects on cells… In this mini-webinar, Adam Elhofy, PhD, CSO, Essential Pharmaceuticals, presents data summarizing the findings of a recent study “Novel Cell-Ess ® supplement used as a feed or as an initial boost to CHO serum free media results in a significant increase in protein yield and production” published in Computational and Structural Biology Journal (Volume 14, 2016, p. 319-324) The study focuses on the use of a novel media supplement called Cell-Ess that increases protein productivity via yield per cell while not impacting the metabolic profile via a unique lipid delivery mechanism. Dr. Elhofy initially gave this talk at Boston Biotech Week 2016, and we are excited to be able to share it on the Cell Culture Dish…Cool Tool – Generation of Neural Stem Cells from AlphaSTEM Cultured Pluripotent Stem Cells
Patient-derived induced pluripotent stem cells (iPSCs) offer exciting potential for disease modeling, regenerative medicine, and therapeutic development. In order to fully realize the potential of iPSCs, it is critical to develop culture and differentiation methodologies that result in the most biologically relevant terminal cells (e.g. Neurons)…
Cool Tool – New KANEKA KanCapA™ 3G for Improved Binding and Milder Elution of Therapeutic Antibodies
Protein A is by far the most common purification method in biopharmaceutical manufacturing. Due to its high affinity and selectivity for therapeutic antibodies, high purity can often be reached in a single step. With the expanding market for therapeutic antibodies, pressure to reduce the cost of pharmaceuticals, and increases in upstream production titers; Protein A improvements have been required to meet industry demands for improved downstream purification efficiency…
Continuous Processing Optimization with Smarter Tools
Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost- effective ways to produce drugs for the patients who need them. As orphan drugs and personalized medicine begin to replace traditional blockbuster products, pharmaceutical companies are looking at new and innovative ways to quickly and efficiently deliver drugs to target populations in the thousands rather than the millions. In addition, the need for lower drug prices has been pushed into the spotlight not just by regulators, but also by the advent of biosimilars. As a result of these changes, industry experts must find a way to produce drugs that address the issues around both drug pricing and time to market while also maintaining quality and profits…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…Cell Culture Events:
Bioprocess International West – February 27-March 2, 2017, San Francisco
The BPI West 2017 agenda format is designed to break down silos across multiple departments that work in the same stage of development. With four concurrent tracks focused on early stage process development through commercial manufacturing, attendees can collectively share challenges and discuss the solutions needed to improve the speed, cost and quality of biologics development. Cell Culture Dish Readers – Click to Get a free Exhibit Hall Pass!Going to BPI West 2017? Don’t miss these great talks and activities!