This week’s headlines include: Tom Price Is Confirmed as Health Secretary, uniQure details three-pronged Gene Therapy trial program, Senators Call on HHS to Allow Canadian Drug Imports if Prices Spike, Emergent Wins BARDA Contract to Develop Viral Hemorrhagic Fever Treatments, Riskiest ideas’ win $50 million from Chan Zuckerberg Biohub, and FDA approves Valeant’s drug to treat plaque psoriasis.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
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)…
Reducing drug development timelines and cost is a goal that we hear repeatedly in the industry. One area where timing is crucial is in reaching a go/no go decision on a therapeutic candidate and efficient production scale up once a go decision has been reached…
I have compiled a list of our top ten Cell Culture Dish “Ask the Expert” and Podcast Sessions for 2016. Here are the top sessions in alphabetical order…
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…
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…
Cell Culture Events:
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.
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
Case Study: Merck Presents Scale Up of Continuous Chromatography using Cadence BioSMB Process System – February 20, 2017
In the present study, the development of a continuous Protein A chromatography process step using KANEKA KanCapA for the capture of a therapeutic mAb is described. The method was developed initially in a batch mode and then transferred to the Cadence BioSMB PD system. This five column process was then successfully scaled-up 150-fold using the Cadence BioSMB Process system. The entire process development and scale-up was completed within four weeks and described in detail along with the process economic benefits of using multi-column chromatography.
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.
“The Senate early Friday approved the nomination of Representative Tom Price to be secretary of health and human services, putting him in charge of President Trump’s efforts to dismantle the Affordable Care Act….”
“uniQure plots to initiate a three-pronged clinical trial program next year as key assets from its in-house pipeline and Bristol-Myers Squibb collaboration advance. uniQure aims to move its hemophilia B Gene Therapy, AMT-060, into a pivotal trial while working to advance a Huntington’s disease asset and Bristol-Myers-partnered heart failure candidate into the clinic…”
“Emergent Wins BARDA Contract to Develop Viral Hemorrhagic Fever Treatments,” Genetic Engineering News
“Emergent BioSolutions said today it will develop monoclonal antibody therapeutics for viral hemorrhagic fever under a task order from the Biomedical Advanced Research and Development Authority (BARDA) that is valued at up to $30.5 million…”
“The biomedical research initiative created by Facebook co-founder Mark Zuckerberg and his wife, physician Priscilla Chan, has awarded its first grants to scientists, on topics ranging from the genomics of obscure microbes to a memory-retrieval device…”
“The U.S. Food and Drug Administration on Wednesday approved Valeant Pharmaceuticals International Inc’s Siliq to treat adults with moderate-to-severe plaque psoriasis. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35.”