This week’s headlines include: Johnson & Johnson refills drug cabinet with $30 billion Actelion deal, Chasing Sanofi, Pfizer tees up phase 3 trials for C. diff vaccine, Eight medicines leap towards EU approval, Novartis says Votubia receives EU approval for new indication, Calithera and Incyte Agree on $53M Up-Front Deal for Clinical-Stage Arginase Inhibitor, and European Commission Offers New Q&A on Biosimilars.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
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…
Cell therapies offer much promise in treating a range of medical conditions, but manufacturing complexity is a challenge when scaling up to clinical and commercial manufacturing. Concerns include developing a process that is efficient and cost effective with consistent, high quality outcomes…
I have compiled a list of our most popular Cool Tools Features for 2016. Here are the top 15 in alphabetical order…
I have compiled a list of our most popular 30 Blogs for 2016. Here are the top Cell Culture Dish blogs in alphabetical order…
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:
This year’s Society for Laboratory Automation and Screening (SLAS) Conference in Washington DC should be an exciting event. I know of a few new products that will be launched at this conference that we will be covering in more detail starting Monday the 6th.
If you’ve been watching, Beckman Coulter has released a series of videos announcing a new addition to their Biomek family of liquid handlers. According to Beckman Coulter the new and improved Biomek is customer driven, with improvements and updates added in response to customer requests. Today’s video confirms they will be revealing the new product at SLAS on Monday.
To see the new Biomek in person, visit Beckman Coulter at SLAS in booth #925.
To see the full mini video series, visit Biomek.Beckman.com
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: CMC Biologics Explores the Potential of Continuous Multi-Column Chromatography – February 6, 2017
The Protein A capture chromatography step for monoclonal antibodies (mAbs) is both costly and challenging. Recent advances in continuous multi-column chromatography have drawn great interest due to the potential to dramatically lower the cost and complication of this key purification step in both semi- or fully continuous application. In this webinar, you will learn more about the practical application of continuous multi-column chromatography from the team at CMC Biologics and Pall Life Sciences.
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.
“U.S. healthcare giant Johnson & Johnson (JNJ.N) will buy Swiss biotech company Actelion (ATLN.S) in a $30 billion all-cash deal that includes spinning off Actelion’s research and development pipeline, the companies said on Thursday. The biggest European drugs takeover in 13 years gives J&J access to the Swiss group’s range of high-price, high-margin medicines for rare diseases, helping it diversify its drug portfolio as its biggest product, Remicade for arthritis, faces cheaper competition….”
“Pfizer’s preventative vaccine against Clostridium difficile has passed a phase 2 test and will start registration studies in the next few months, in hot pursuit of a rival candidate from Sanofi. Infections caused by C. diff are on the rise and resistance to antibiotics is a growing problem, so there is intense interest in a vaccine that could protect patients from the pathogen, which is a leading cause of hospital-acquired infections…”
“Eight medicines – including two biosimilars – have taken a giant step towards being approved for the European market having won favour with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)…”
“Novartis has broadened the indications for its Votubia drug, the company said on Tuesday, when the European Union approved its use to treat refractory partial-onset seizures in patients with tuberous sclerosis complex…”
“Calithera and Incyte Agree on $53M Up-Front Deal for Clinical-Stage Arginase Inhibitor,” Genetic Engineering News
“Incyte and Calithera Biosciences inked a global collaboration and licensing deal to develop and commercialize the latter’s early clinical-stage small-molecule arginase inhibitor CB-1158. Incyte will pay Calithera $45 million upfront and will make an $8 million equity investment in the company, in return for global rights to CB-1158 for applications in hematology and oncology. Calithera retains certain rights covering research, development, and commercialization of arginase inhibitors for other orphan indications…”
“The European Commission on Monday unveiled a new question and answer document for those looking to better understand biosimilar. Similar to the Focus explainer on biosimilars, the 9-page EC explainer, available in seven languages, offers a quick 10,000-foot view of the biosimilars landscape, answering questions that patients might have on what a biologic is, what a biosimilar is, how biosimilars compare to generics, what types of studies biosimilars must undergo prior to approval and how to define extrapolation.”