This week’s headlines include: World Health Officials Describe Progress Against Tetanus, H.I.V. and Malaria, MD Anderson, Pfizer Launch Immuno-Oncology Collaboration, Multiple myeloma trial opened to patients, EU green light for Roche’s Tecentriq, Pfizer launches upstart with $103M, phase 3-ready drugs, Genetically modified approaches to fighting malaria succeed in new tests, and The HPV Vaccine Gains Ground Among U.S. Teenagers.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
BPI East 2017 begins September 25th in Boston. 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 East related blogs over the next month.
If you are attending, don’t miss these exciting talks and activities!
Transcriptome analysis reveals strategies for CHO cell culture media design and feed-spiking strategy to improve batch culture
When looking at batch vs. fed-batch culture, there are advantages and disadvantages to each, so considering the application is very important. Batch cultures are fairly simple, straightforward and take very little time to set up. However, batch culture typically doesn’t yield high mAb titers, due to nutrient depletion, by-product accumulation and short growth and production phases. So a batch approach may be good for lab-scale processes where product needs to be generated quickly and simply with little optimization. In contrast, with fed-batch culture, feeds are added to replenish nutrients, which increases cell concentrations, process time, and can yield much higher titers. However, fed batch culture also requires more time for optimization and resources to run. So this approach is more beneficial in situations where you would are developing long term processes or scaling up to large-scale production…
This study highlights the possibility of automated viral integrity measurements of Adeno-associated virus (AAV) and Adenovirus particles and underscores the importance of these measurements being performed in on-grid areas with appropriate stain quality. The analysis is performed using MiniTEM-enabled automated imaging, particle detection, classification and quantification. The analysis provides, a metric for determining the proportion of intact or broken particles in virus samples. In addition, as broken AAV particles may occasionally form undesired doublets or triplets, a metric for determining the proportion of such AAV particle formations is also demonstrated…
In this mini-webinar, Scott Waniger, VP Bioprocessing, Cell Culture Company, presents a cost effective, early stage clinical trial production process. This process utilizes a continuous upstream manufacturing approach, which reduces production time, lowers cost and simplifies scale-up. To begin the webinar, Mr. Waniger describes current challenges in commercial drug manufacturing. With one of the most pressing, being the overall rise in aggregate costs. He explains that the overall cost of commercializing a drug, based on last year’s data is $2.6 billion dollars. This represents a 3 fold increase over just the past 12 years. In addition, these candidates have a high failure rate with only 1 in 10 Phase I drug candidates (1 in 20 for oncology drugs) reaching approval. These high costs coupled with high failure rates represents a huge financial risk for biopharmaceutical companies. As such, decreasing costs associated with clinical trials has been identified as a top priority for many pharmaceutical companies…
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.
“Infant and maternal tetanus was officially eliminated from the Americas this year, the Pan American Health Organization announced on Thursday. At one time, the infection killed about 10,000 newborns annually in the Western Hemisphere; tetanus still kills about 35,000 infants around the world…”
“The University of Texas MD Anderson Cancer Center will join with Pfizer to study novel combinations of three of the pharma giant’s immuno-oncology candidates and other Pfizer treatments for solid and blood cancers, the partners said today, through a collaboration whose value was not disclosed…”
“San Diego’s Poseida Therapeutics has begun enrolling patients in a clinical trial of a therapy for those with multiple myeloma. While the trial is mainly concerned with safety, it’s also designed to look for signs of efficacy, Eric Ostertag, M.D., CEO of the privately held company, said Tuesday. The genetically engineered therapy is made from a patient’s own T cells, part of the immune system. They are genetically engineered to fight the blood cancer. These engineered cells, called CAR T cells, have shown great promise in experimental treatments…”
“Roche has received European Commission approval for its anti-PD-L1 cancer immunotherapy Tecentriq (atezolizumab) to treat specific lung and bladder cancers. The green light means that it can be used as monotherapy for people in the EU with previously-treated locally advanced or metastatic non-small cell cancer (NSCLC), or those with metastatic urothelial carcinoma (mUC) who have received a platinum-based chemotherapy or who are ineligible to receive cisplatin chemotherapy…”
“In a first for the Big Pharma and as part of a new model, Pfizer is taking drugs from its shelves and licensing them to, while investing in, its SpringWorks Therapeutics startup. It starts life with a major $103 million series A with help from Bain Capital Life Sciences, Bain Capital Double Impact, Orbimed and LifeArc. Pfizer’s input consists of both equity capital and royalty- and milestone-bearing licenses to a series of experimental meds…”
“In the annals of deadly diseases, few have plagued humankind as viciously as malaria. In ancient times, Hippocrates attributed malarial fevers to bad air. At one point, the Roman Empire directed those suffering from fever to wear amulets inscribed with “abracadabra” to ward off the disease…”
“More than half of all American teenagers are getting vaccinated against human papillomavirus, and the rate is rising over time, according to a new report from the Centers for Disease Control and Prevention. Sixty percent of adolescents received one or more doses of the HPV vaccine in 2016, an increase of 4 percentage points from 2015, researchers found. About a decade ago, the figure was less than 30 percent…”