This week’s headlines include: Kite Pharma shares soar after cancer therapy study shows good results, Deadly, Drug-Resistant ‘Superbugs’ Pose Huge Threat, W.H.O. Says, Activating a cell-protecting protein could ward off Alzheimer’s symptoms, China’s Bird Flu Surge Is a Low Epidemic Threat, W.H.O. Says, Advaxis Inks Deal with Sellas to Develop New Cancer Immunotherapy, Cypralis Wins ADDF Funding to Support Cyclophilin D Inhibitor Program, and ILS Automation launches micro-pumps to provide precise control at low flow.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Mycoplasma contamination is a very real concern for research labs. Mycoplasma contamination can compromise cell culture and experiment results, thus wasting valuable resources conducting experiments that ultimately aren’t accurate. Because mycoplasma contamination actually affects the cells’ overall behavior, contamination can result in false interpretation of experimental results and undermines the validity of the resulting data.
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…
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)…
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…
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…
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:
World Vaccine Congress – April 10-12, 2017, Washington D.C.
The 17th Annual World Vaccine Congress is the place where the global vaccine industry meets to discuss commercial and scientific issues around regulation, strategy, manufacturing, trials, partnering, influenza, cancer, emerging diseases and veterinary vaccines.
Across 150 sessions, you will learn from leading experts across the issues most impacting on the wider vaccine sector, as well as delve into your specialist area of research and job focus in co-located conferences.
Meet over 700 of your peers in one room and take advantage of the multiple extended networking breaks, co-located World Vaccine Congress (including 7 streams on Immune Profiling, Cancer & Immunotherapy, Influenza & Respiratory, Clinical Trials, Emerging Diseases, Partnerships, Veterinary Vaccines and Bioprocessing & Manufacturing) as well as the evening drinks reception.
For more information, please visit the website https://goo.gl/nJ2bZ1
Cell Culture World Congress USA 2017 – May 24, 2017, Hilton San Diego Resort and Spa, San Diego, CA
The vision of Cell Culture World USA is to provide new, relevant content on process development for cell culture specific scientists working in bio manufacturing companies developing antibodies and immunotherapies. Over 4 years, the Congress has become a technical and networking forum for bioprocessing professionals to provide cutting-edge commentary, present novel and never-before-seen case studies, and highlight technological advancements to the industry.
Our 2017 event will feature a more focused structure, zeroing in on the topics that interest cell-culture specific scientists the most. Immunotherapies are the talk of the industry, and they’ll be a huge topic for this year’s event as well.
Download Brochure: https://goo.gl/t5ZRvx
Register now: https://goo.gl/KTOdxq
Continuous Bioprocessing Solutions: An Update on Significant Enabling Technology Advances – March 7, 2017
While continuous processing has been applied for several decades, the highly regulated biopharm industry has just started to embrace this approach. The team at Pall Life Sciences has leveraged an industry-leading single-use portfolio to deliver innovative continuous bioprocessing solutions to the market. Join our team as they detail the development journey, and highlight critical advances to date.
“An experimental Gene Therapy that turns a patient’s own blood cells into cancer killers worked in a major study, with more than one-third of very sick lymphoma patients showing no sign of disease six months after a single treatment, Kite Pharma Inc. said Tuesday…”
“The World Health Organization warned on Monday that a dozen antibiotic-resistant “superbugs” pose an enormous threat to human health, and urged hospital infection-control experts and pharmaceutical researchers to focus on fighting the most dangerous pathogens first…”
“University College London scientists have identified the inhibitor of a cell-protecting protein as a promising new target in treating Alzheimer’s disease. They tested the approach in fruit fly and mouse models and hope to translate their work to human nerve cells…”
“Although there has been a surge in human infections with H7N9 avian flu in China this winter, the risk of an epidemic remains low, a World Health Organization official said on Wednesday…”
“Advaxis and Sellas Life Sciences Group, two companies that have pursued different ways of prompting the body’s immune system to fight cancer, are now hoping that combining their efforts will lead to a more precise treatment…”
“U.K.-based Cypralis has been awarded $524,000 by the Alzheimer’s Drug Discovery Foundation (ADDF). The firm said the award will support its existing neurodegenerative disease therapeutics partnership with Janssen Pharmaceuticals…”
“ILS Automation launches micro-pumps to provide precise control at low flow,” Filtration and Separation
“Designed for cell-culture and fermentation applications in bench-to-pilot scale reactors, the AFC 928 offers precise control over very low flow applications down to 0.05 ml/hr, allowing labs to replace their external syringe pumps with fully integrated peristaltic pumps…”