This week’s headlines include: Cellectis gets U.S. go-ahead to test ‘off-the-shelf’ Cell Therapy, Serono spinout raises €29M for phase 2 Parkinson’s trials, BioTime Acquires Retinal Repair Cell Therapy from UPMC, How the Anti-Vaxxers Are Winning, U.S. FDA approves Bristol-Myers’ Opdivo for bladder cancer, and 13 UC Berkeley faculty members awarded research grants by CZ Biohub,” The Daily Californian
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
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…
Recently, BioProcess International in conjunction with Pall Life Sciences published an informative supplement titled, “Is Continuous Bioprocessing the Future? ”. The publication contains 12 articles covering various aspects of continuous bioprocessing as well as additional articles on enabling technologies. I found the supplement to be a useful update on continuous bioprocessing technology benefits, implementation challenges and successes, as well as what the future holds…
Automation is a hot topic lately as it has the potential to overcome key hurdles in both research and biomanufacturing. It is being utilized to provide high throughput, reduce labor requirements, increase consistency and eliminate bottlenecks…
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…
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…
I have compiled a list of our most popular 10 Blogs for 2016. Here are the top Downstream Column blogs in alphabetical order…
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.
“Cellectis has won U.S. regulatory approval to run an early clinical trial using its gene edited Cell Therapy product UCART123 for blood cancers, boosting the French biotech firm’s ambitions in the hot area of cancer research...”
“Prexton Therapeutics has raised €29 million ($31 million) to take its Parkinson’s disease candidate through two phase 2 trials. The Series B positions the Merck Serono spinout to build on last year’s phase 1 success by testing the mGluR4 positive allosteric modulator in larger efficacy studies…”
“Regenerative medicine company BioTime expanded its ophthalmology portfolio through the acquisition of global rights to the University of Pittsburgh Medical Center’s (UPMC) stem cell-derived retinal repair platform IP. The Cell Therapy technology, developed in partnership with BioTime, generates 3-D retinal tissue from human pluripotent stem cells for use as implants to repair retinas in patients with advanced retinal degradation. The licensing deal has been made through UPMC’s Innovation Institute…”
“It’s looking as if 2017 could become the year when the anti-vaccination movement gains ascendancy in the United States and we begin to see a reversal of several decades in steady public health gains. The first blow will be measles outbreaks in America…”
“The U.S. Food and Drug Administration on Thursday expanded the use of Bristol-Myers Squibb Co’s Opdivo to include treatment of urothelial carcinoma, the most common type of bladder cancer…”
“Thirteen UC Berkeley faculty members have been awarded up to $1.5 million in grants each by the Chan Zuckerberg Biohub to carry out biomedical research. CZ Biohub — founded in September 2016 with an investment from Facebook founder and CEO Mark Zuckerberg and his wife, pediatrician Priscilla Chan — is a nonprofit medical research organization dedicated to encouraging and funding research related to finding cures for diseases. The 13 campus faculty are part of a group of 47 investigators chosen by CZ Biohub, who come from Stanford University, UC San Francisco and UC Berkeley, the organization’s partners.”