This week’s headlines include: BrainStorm seeks early approval for stem cell treatment in Canada, Gates Foundation boosts UCSD-led malaria research, Biosimilar Inflectra matches Remicade efficacy in trial, and New culture method boosts T cells’ ability to recognize multiple cancers.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
BPI West 2017 begins February 27th in San Francisco. The conference is focused on providing companies the opportunity to share ideas, strategies and solutions to overcome challenges at every stage of development. Cell Culture Dish/Downstream Column will be attending and blogging from the event. Please don’t miss our BPI West related blogs over the next month.
If you are attending, don’t miss these exciting talks and activities!
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:
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
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.
“Israel’s BrainStorm Cell Therapeutics is seeking early approval in Canada for its adult stem cell treatment for patients with amyotrophic lateral sclerosis (ALS), a neuro-degenerative disease, even before it completes late-stage clinical trials….”
“The Bill and Melinda Gates Foundation has awarded a $4.7 million supplemental grant to a UC San Diego-led research consortium to develop therapies to eradicate malaria. The 3-year grant is led by Elizabeth Winzeler, professor in the pediatric division of host-microbe systems and therapeutics at UCSD School of Medicine…”
“Pfizer and Celltrion have unveiled Phase III study data comparable safety and efficacy between biosmilar Inflectra and reference drug Remicade in patients with moderate-to-severe Crohn’s disease (CD)…”
Engineered T cells, which aim to mount an immune response against cancer, are gaining steam in the immuno-oncology market, with Kite Pharma and Novartis racing to get their CAR-T therapies for blood cancers approved. But they don’t work for all patients, and researchers have struggled to find uses for them in solid tumors.