This week’s headlines include: Impressed FDA panel unanimously recommends GSK shingles vaccine, FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements, Ventria Bioscience Plans to Double Biomanufacturing Capacity, California Assembly passes drug price transparency bill, Merck’s Keytruda-chemo combo spurs big response in new stomach cancer patients across the PD-L1 board, New clinical trial might change the standard treatment for melanoma, and Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies.

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

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…

Development of DoE based fed-batch strategies for high-producing CHO cell cultures

Successful optimization of Chinese hamster ovary (CHO) cell culture for biomanufacturing has a significant impact on productivity, protein quality, manufacturing efficiency and economic feasibility. To achieve the highest performing cell culture, a fed-batch culture strategy is frequently used. In fed-batch culture, it is important to begin with a robust base media and then add a complimentary feed strategy…

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…

Continuous bioprocessing – moving from theory to reality

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

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. View Agenda: bit.ly/2b80uCZ 4 interactive streams: 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:

“‘Impressed’ FDA panel unanimously recommends GSK shingles vaccine,” Reuters

“A U.S. Food and Drug Administration advisory panel on Wednesday voted 11-0 that the safety and efficacy of GlaxoSmithKline’s Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over. Panel members said they were “very impressed” by efficacy data from Shingrix clinical trials, and that it represents an improvement over Zostavax, the only marketed shingles prevention vaccine from Merck & Co…”

“FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements,” Regulatory Focus

“FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations. The situation, according to Gottlieb, arises if sponsors received an orphan designation for a pediatric subtype of an otherwise common and non-orphaned adult disease…”

“Ventria Bioscience Plans to Double Biomanufacturing Capacity,” Pharmaceutical Processing

“Ventria Bioscience Inc. announced an expansion of biomanufacturing and laboratory facilities to roughly double Ventria’s capacity for production of recombinant proteins. The company broke ground today on the expansion of its molecular biology lab, greenhouses, process development and analytical lab, and processing capacity in Junction City, Kansas. Ventria’s proprietary ExpressTec platform for biomanufacturing produces biological products known for purity, safety and cost-effectiveness…”

“California Assembly passes drug price transparency bill,” San Jose Mercury News

“The California State Assembly on Monday overwhelmingly approved Senate Bill 17, controversial legislation that could soon become the nation’s most comprehensive law aimed at shining a light on prescription drug prices. The 66-9 vote easily overcame the 41 votes needed to pass, though an earlier vote late Monday afternoon had come up short at 31-6. At that point, the bill was put on call and the voting roll was kept open for less than an hour until the final vote was called…”

Merck’s Keytruda-chemo combo spurs big response in new stomach cancer patients across the PD-L1 board

“Merck immuno-oncology star Keytruda has posted updated, longer-term positive data in previously untreated stomach cancer patients—and some new data showing it could be effective for some patients much later in therapy, too. Friday at the European Society of Medical Oncology (ESMO) annual meeting in Madrid, the New Jersey drugmaker presented data from all three cohorts of a phase 2 trial. Two of them, made up of previously untreated patients, build on data the pharma giant rolled out at ASCO, adding three months of additional follow-up that demonstrated “durability of clinical benefit,” a spokesperson said by email…”

“New clinical trial might change the standard treatment for melanoma,” Washington Post

“In a head-to-head comparison of two immunotherapy drugs used to prevent relapse in certain patients with advanced melanoma, one treatment was the clear winner — and it’s not the one that most people get. The international study, released Sunday, involved 900 patients whose tumors were removed by surgery but who remained at high risk of recurrence of melanoma, an often aggressive form of skin cancer…”

“Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies,” Regulatory Focus

“FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective. Opening with a discussion of the ways in which the gap of time between the discovery of the science behind new treatments and the adoption of such treatments has been shrinking, Gottlieb outlined a few of the ways in which the agency is modernizing its approach to collecting and evaluating clinical information…”

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