This week’s headlines include: Bill and Melinda Gates Grade the World’s Health, How poliovirus unleashes an attack on glioblastoma, FDA Grants Orphan Drug Status to Amylyx’s AMX0035 for Treatment of ALS, Pain Therapeutics Wins Grants to Develop Alzheimer’s Blood Test and Fentanyl Patch, and Pfizer, and Astellas prostate cancer drug promising in late-stage trial.

In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

BPI East is next week! Hope to see you there – don’t miss these great talks and activities!

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…

Automated integrity analysis of AAV and Adenovirus particles using MiniTEM

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…

De-risking early stage clinical trials – an upstream continuous production solution for biologics

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…

Automated, single-use filtration to increase efficiency in upstream and downstream operations

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…

Cool Tool – Achieve Integrated and Scalable Continuous Chromatography

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…

Events:

September

Bioprocess International Conference (BPI East)
September 25-28, 2017
Hynes Convention Center,
Boston, MA

The largest bioprocessing event bringing you the science, technologies and partners needed to accelerate promising biologics towards commercial success. BPI provides the solutions needed to move drug candidates closer to approval.

Connect with 1800+ bioprocessing leaders at BPI Boston Sept 25-28.  Register w/ code DISH200 by Sept 20 & Save $200 www.BPIevent.com

Don’t miss our activities highlight blog –

BPI East is next week! Hope to see you there – don’t miss these great talks and activities!

October

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!

November

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.

Headlines:

“Bill and Melinda Gates Grade the World’s Health,” The New York Times

“Bill and Melinda Gates handed the world a report card last week, assessing its progress on 18 global health indicators: infant mortality, AIDS, vaccine use, smoking rates and so on. Called “Goalkeepers,” the report was a huge statistical effort, three years in the making, aimed squarely at the world leaders gathering at the United Nations General Assembly this month. To draw extra attention to it, the Gateses will hold an awards dinner and a public release this week featuring former President Obama…”