This week’s headlines include: Novartis wins speedy U.S. review of new leukemia drug, F.D.A. Will Allow 23andMe to Sell Genetic Tests for Disease Risk to Consumers, Kite completes FDA CAR-T filing, posts improved data, Plan to Cut Funding for Biomedical Research Hits Opposition in Congress, For Bristol-Myers, A Victory And A Mystery, and Teva wins FDA approval for Huntington’s drug.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
According to a recent report from PhRMA, U.S. biopharmaceutical companies spend more than 13 times the amount of R&D per employee than all other manufacturing industries.(1) This is because potential drug candidates require lengthy and complex testing to ensure they are safe and effective for patients. Yet, despite all of the money invested, only about 12 percent of the drug candidates that make it into Phase 1 testing are approved by the FDA. While knowledge about a disease and its potential treatment is not lost with “failed” candidates, innovative research tools must be used to avoid spending time, money, and effort on products that have limited endpoint efficacy. Through the implementation of automation, data management, and analytical technologies, pharma has the opportunity to breathe new life into a number of areas of the biologics drug development process…
As an industry, biopharmaceutical manufacturing has moved away from using animal components in media formulation. This move was largely motivated by the desire for increased consistency, an improved safety profile, and a simplified regulatory pathway. Gene and immunotherapies are now increasingly making their way to clinical trials and once again, there is a desire to move away from media that contain animal-based and other undefined components. Even more important in these therapies is the impact that animal components and their naturally occurring cytokines and growth factors can have on cells…
In this poster, researchers at Minerva Biotechnologies describe their discovery of a novel growth factor, NME7AB, and its use in the AlphaSTEM® Culture System. NME7AB is expressed in the inner cell mass of the human blastocyst. By using this growth factor with Yamanaka factors in AlphaSTEM™ Naïve hPSC Medium over an antibody culture substrate, the authors present data demonstrating an increase in iPSC feeder free reprogramming efficiency by 1-2 orders of magnitude…
We recently finished our Ask the Expert discussion, “Maximizing Transient Protein Production”. During this Ask the Expert session, we discussed factors that influence transfection, troubleshooting, and optimizing productivity. Specific topics included host cell choice, target types, factors that impact transfection efficiency, increasing titers, and improving quality…
In this podcast, we interviewed Hillary Kaplan, Director, Bioprocess CMC Development & Operations, Klein Hersh about the job outlook for the biomanufacturing industry from a recruiter’s perspective…
To reduce costs, increase flexibility and shorten time to market, the use of single use and disposable technologies have increased significantly in biopharmaceutical development and manufacturing. In downstream processing prepacked chromatography columns reduce the need for time consuming cleaning validation and column packing. The last few years has seen a steadily increasing implementation of prepacked chromatography columns in process development and clinical manufacturing. Many of these projects are now scaling up for commercial production…
The increase in adoption of single-use bags for manufacturing biopharmaceuticals has been driven by the many advantages it offers. However, the materials of construction can be more complex than conventional stainless steel vessels. Single-use containers are constructed from plastic films, which are often composed of several layers of polymers with additives for processing and performance…
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…
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
MarketsandMarkets put together a unique platform to establish the reproducible and robust manufacturing processes for the production of stable cell culture and therapeutic cells. At the Cell Culture & Cell Therapy: Bioprocessing Conference scheduled to be held in Philadelphia, USA on 26 – 27 June 2017, leading experts in the industry will be gathered to discuss strategies, technologies and innovations in the area of bioprocessing of cell culture and cell-gene therapies.
“A new leukemia treatment from Novartis for children and young adults will get priority review from the U.S. Food and Drug Administration (FDA), putting the Swiss drugmaker ahead of rivals working on similar cancer therapies. The FDA’s announcement late Wednesday means the regulator plans to take action within six months on Novartis’s so-called chimeric antigen receptor T Cell Therapy, or CAR-T, in partnership with University of Pennsylvania researchers…”
“For the first time, the Food and Drug Administration said it would allow a company to sell genetic tests for disease risk directly to consumers, providing people with information about the likelihood that they could develop various conditions, including Parkinson’s and Alzheimer’s…”
“Kite Pharma completed an FDA submission for its CAR-T therapy hours before its self-imposed target passed. Finishing the application on Friday meant Kite met its goal of filing in the first quarter, and put it days behind Novartis in the race to bring a CAR-T therapy to market…”
“A proposal by President Trump to cut federal spending for biomedical research by 18 percent — just months after Congress approved bipartisan legislation to increase such spending — has run into a buzz saw on Capitol Hill, with Republicans and Democrats calling it misguided…”
“New data presented at a medical conference show that combining Bristol-Myers Squibb’s two immune-boosting cancer drug appears to extend the lives of melanoma patients longer than using either alone. But a big question lingers about one of the drugs, Opdivo: why did it fail to extend survival in patients with previously untreated non-small cell lung cancer, when a very similar drug from Merck proved effective? A trial being presentd this afternoon may yield some clues. Both studies are being presented at the annual meeting of the American Association for Cancer Research…”
“Israel-based Teva Pharmaceutical Industries Ltd said the U.S. Food and Drug Administration had approved its drug to treat chorea stemming from Huntington’s disease, a fatal degenerative disorder. Chorea is an abnormal, involuntary writhing movements disorder that occur in 90 percent of Huntington’s disease patients at some point in the course of their illness…”