This week’s headlines include: As Cancer Tears Through Africa, Drug Makers Draw Up a Battle Plan, Zika vaccine shows promise in early human trial, FDA advisers urge approval for first Gene Therapy for inherited disease, Ask The Disease Specialist: Why Is It So Hard To Beat The Plague?, New study identifies genes that can help in lymphoma treatment, and Averting toxic side effects from CAR-T cancer treatments.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
In this podcast and accompanying article, we interviewed Ken Clapp, a senior member of GE Healhcare Life Sciences’ upstream product management team. We discussed the use of single-use bioreactors for fermentation, how single-use technology has evolved to meet the more rigorous demands of fermentation, and the benefits of single-use for this application…
Immunotherapy, particularly for cancer treatment, is a very active area of both academic and clinical research. There has been increased interest in utilizing a patient’s own T cells to attack their tumors. However, positive laboratory results do not always translate from bench to the clinic, and the effectiveness of immune cells therapies are not equivalent for all patients or cancer types. To better understand these differences, there is a need for improved in vitro oncological models that more closely resemble the tumor environment in vivo. Traditionally, tumoricidal activity and immune evasion have been studied by utilizing two dimensional systems (2D) which may not accurately reflect the complexity of a three dimensional (3D) tumor. The physical barriers immune cells need to overcome in a 3D system are much greater than those of 2D. Not only do immune cells need to migrate to the tumor site, but they also need to infiltrate a 3D structure in order to attack the target cells. Furthermore, it has been shown that phenotypic differences occur in 3D-cultured tumor cells that allow for a higher resistance to cytotoxicity1-2. Here, we demonstrate a novel, high-throughput 3D model to study cancer/immune cell interactions by combining two commercially available products; 96 well ultra-low attachment microplates and 96 well permeable support systems. By replacing the standard 2D flat-bottom permeable support receiver plate with an ultra-low attachment microplate, an easy-to-use, 3D, high-throughput assay to investigate immune cell homing, tumor cytotoxicity, and tumor immune evasion is achieved…
Cell line development is a crucial part of biomanufacturing and sets the stage for future success by enabling the discovery of high yield and high quality clones. Within the cell line development workflow, one of the most critical steps is single cell isolation. The goal is to culture single cells in individual wells, which is necessary to ensure clonality. The FDA requires proof of clonality and companies must provide evidence that each cell line used in manufacturing has been generated from a single cell. This verification typically involves a combination of statistics and images to provide the required evidence…
Matrigel matrix is available is several formulations and can be used in a variety of different ways. With this flexibility comes the opportunity for expert advice and guidance to optimize the product selection and protocols most appropriate for particular cell types or applications. Corning recently published “The Ultimate Guide to Matrigel matrix” to share some of the best tips, tricks and expert advice. We encourage you to request your copy of the guide, available in both electronic and hard copy versions. And if you have more specific questions, we have two Corning Matrigel matrix experts hosting this Ask the Expert Session this week…
Cool Tool – ‘Jetting’ technology for manufacturing agarose beads with enhanced performance characteristics
The vast majority of chromatography resins designed for large-scale bioprocess chromatography separation are produced using traditional batch emulsification in conventional stirred-tank reactors. In these cases, the size of the beads formed in the reactor is a function of the shear force generated by the impeller. The faster the impeller speed, the smaller the beads are. As a result, there is a wide particle size distribution of the manufactured beads. Furthermore screening is required to remove coarse and fine beads, which detract from column performance. This screening is extremely time consuming particularly for smaller beads (less than 65 µm). The smaller the bead being produced the lower the achieved yield so realistically one cannot make beads financially viable less than 40 µm. It also adds high costs due to the additional time in the manufacturing facility with large volumes of waste from the fine and coarse beads. Even after this screening, the resin will still have a relatively wide size particle distribution…
In examining ways to improve overall bioprocess efficiency, filtration is a step that can sometimes be overlooked. However it is a key area to improve efficiency, as it is part of both upstream and downstream operations and consumes sizeable resources. The application of single-use technologies coupled with increased automation have successfully improved efficiency in other bioprocess operations, thus it is logical that filtration would also benefit from these technologies…
Bioburden Contamination in Downstream Bioprocesses – Potential entry points for contamination and innovative solutions
Bioburden contamination in biopharmaceutical manufacturing is a big concern. Contamination carries both tremendous cost and preventing it requires strict control of several possible entry points. The cost of bioburden contamination for a company can involve lost time, lost material, batch loss, possible facility closure and extensive QA/QC time to ensure proper cleaning and validation. In the worst case scenario, it can prevent supply of much needed medicine to patients and loss of commercial revenue…
Over the last decade, advances in the upstream processing of monoclonal antibodies (mAbs) has resulted in higher bioreactor titers. With increasing titers, the production bottleneck has shifted to downstream processing. Hence, the biopharmaceutical industry has reached a milestone where the need for higher throughput in downstream processing is leading to the adoption of more efficient multi-column continuous (MCC) counter-current chromatography systems which increase overall productivity while significantly reducing consumables costs…
October 18, 2017 at 10:00 EST
The number of Gene Therapy applications based on viral vectors are growing and small-scale manufacturing processes are increasingly requiring scaling up to commercial processes.Numerous challenges must be overcome in scaling-up to full commercial production Undesired outcomes may slip through if not monitored carefully during the process development.
This webinar will show how MiniTEM can reveal powerful data where traditional assays have limitations.
With the introduction of the MiniTEM™ system, transmission electron microscopy has become an accessible method for routine testing in bioprocessing. Through automated image acquisition, particle detection and classification MiniTEM can provide both high-resolution images and reliable quantitative data in a very short turnaround time.
Presented by Josefina Nilsson, Head of EM Services
Register to this webinar to learn more. – http://bit.ly/2i7TWYw
World Vaccine Congress
October 10 – October 12
CROWNE PLAZA BARCELONA, BARCELONA, Spain
Make sure you are at the forefront of the vaccines industry. No matter where your interest lies, at the 18th annual World Vaccine Congress we have content, networking and potential partners for you.
Speed to IND for Biologics
October 19 – October 20
Hyatt Centric Fisherman’s Wharf, 555 North Point Street
San Francisco, 94133 United States
With 32 expert presenters, 20 case studies/new data presentations and just two days out of the office, you won’t want to miss this first-of-its-kind event!
Do you have a burning regulatory question? Come and get your queries answered with 4 parallel conference tracks on Regulatory Affairs in Emerging Markets, IDMP, Global eSubmissions and Biosimilars. We offer a new central European location, a focused agenda and more opportunities for you to collaborate and connect.
To learn more, please see – https://lifesciences.knect365.com/global-pharma-regulatory-affairs/
3rd Annual Cell & Gene Therapy Congress
November 6 – November 7
immarsat, 99 City Road
London, EC1Y 1AX United Kingdom
Oxford Global Conferences presents its 3rd Annual Cell & Gene Therapy Congress, with our co-located 6th Annual Cell Culture & Bioprocessing Congress and 4th Annual Stem Cell Congress and, 6 – 7 of November 2017, London, UK.
Cell & Gene Therapy: Development & Clinical Trials Cell Therapy Bioprocessing and Manufacturing Presentations will include cell & Gene Therapy development, updates in regulatory pathways, commercialisation, bioprocessing and manufacturing.
World Orphan Drug Congress Europe
November 13 – November 15
FAIRMONT REY JUAN CARLOS I, Av. Diagonal, 661-671
BARCELONA, 08028 Spain
The 8th annual World Orphan Drug Congress is the marketplace for orphan drug professionals looking at the complete value chain of orphan drug development, from clinical development and R&D to corporate development and market access.
“In a remarkable initiative modeled on the campaign against AIDS in Africa, two major pharmaceutical companies, working with the American Cancer Society, will steeply discount the prices of cancer medicines in Africa. Under the new agreement, the companies — Pfizer, based in New York, and Cipla, based in Mumbai — have promised to charge rock-bottom prices for 16 common chemotherapy drugs. The deal, initially offered to a half-dozen countries, is expected to bring lifesaving treatment to tens of thousands who would otherwise die…”
“A DNA-based Zika vaccine from Inovio Pharmaceuticals Inc and South Korea’s GeneOne Life Science Inc induced anti-Zika immune responses in an early stage human trial, U.S. researchers reported on Wednesday…”
“A Food and Drug Administration advisory committee unanimously endorsed an experimental Gene Therapy Thursday for patients with a rare kind of hereditary blindness, setting the stage for a historic approval. If the agency agrees with the recommendation, the one-time treatment would be the first Gene Therapy cleared in the United States for an inherited disorder…”
“An outbreak of the plague is growing in Madagascar. Air Seychelles announced that it has canceled all flights into the country after a traveler returned to the Seychelles with the illness — despite World Health Organization guidance against travel restrictions because “the risk of international spread of plague appears very low.” WHO has sent enough antibiotics to treat more than 5,000 people who’ve come down with the disease and a team of five people as well…”
“Lymphoma patients who don’t respond to chemotherapy may be able to seek alternative treatment more quickly, thanks to new research from Duke. Duke Cancer Institute researchers analyzed tumor samples from 1,001 patients with diffuse large B cell lymphoma, the most common form of the disease. After sequencing the tumors, the researchers identified 150 genes that could indicate ahead of time whether chemotherapy would be effective in fighting a patient’s lymphoma. The scientists say knowing that chemotherapy will not be effective can help doctors devise different treatments sooner…”
“As excited as the oncology community is about the recent approval of Kymriah, Novartis’ CAR-T treatment for some patients with lymphoma, concerns about side effects remain. Some patients in clinical trials of Novartis’ product and others have developed a dangerous immune reaction called cytokine release syndrome, while others have suffered from neurotoxicity. The side effects can be life-threatening…”