This week’s headlines include: FDA lays out new manufacturing inspection blueprint, Bayer, J&J in frame for bigger anti-clotting market opportunity, Diabetes drug results positive, Ligand says, Industry groups sue over Nevada drug price transparency law, Novartis Calls the Doctor to Push Breakthrough Drugs Forward, and Was the big paper about the successful editing of human embryo genes wrong.

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

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…

Ensuring FBS traceability using chemical fingerprinting

Fetal bovine serum (FBS) quality and traceability are very important, particularly in applications where the product is being used in biomanufacturing. While there has been a trend in much of the biopharmaceutical industry to move away from animal-derived products, the vaccine industry still uses FBS in vaccine production…

All About Organoids

Held this year in Boston MA, the International Society for Stem Cell Research (ISSCR) Conference 2017 brought together more than 4,000 researchers, bioethicists, clinicians, and industry professionals from all over the globe to discuss the latest discoveries and technologies in Stem Cell Research and their contributions to advancing regenerative medicine. This year, the plenary session topics included an exciting and rapidly expanding area of research—organoids. An organoid, in the most basic sense, is a miniaturized and simplified version of an organ produced in vitro in three dimensions that show realistic micro-anatomy. Unlike two dimensional (2D) cell cultures, organoids enable three-dimensional (3D) cell growth, movement and differentiation, making this technology an effective model for understanding organ development, tissue morphogenesis and the genetic or molecular basis of diseases (Xinaris et al, 2015)…

Efficient Large-Scale Expansion of MSCs for Translational Medicine and Research Use

As part of our ongoing conference coverage of ISSCR 2017, we like to feature posters from the event. One poster covered the very important topic of large-scale expansion of mesenchymal stem cells (MSCs) for both research and translational medicine. The poster, “Expansion of MSCs for Translational Medicine using MSC NutriStem® Basal Medium and PLTMax® Human Platelet Lysate,” was jointly presented by Biological Industries USA and Mill Creek Life Sciences, and highlighted at the Biological Industries booth. In the poster, authors describe the importance of successful large-scale expansion of MSCs and present data on a culture protocol that has generated very successful results…

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:

“FDA lays out new manufacturing inspection blueprint,” FiercePharma

“The FDA is reorganizing the way it handles manufacturing inspections, saying the new system should speed drug approvals and eliminate surprises that drugmakers sometimes face when plant questions delay them…”

“Bayer, J&J in frame for bigger anti-clotting market opportunity,” Reuters

“Bayer and Johnson & Johnson’s blockbuster clot prevention drug Xarelto was shown to cut the risk of potentially deadly strokes and heart attacks in patients with severe atherosclerosis by 24 percent, raising the prospects of billions more in sales…”

“Diabetes drug results positive, Ligand says,” San Diego Union Tribune

“An experimental drug for type 2 diabetes significantly and safely lowered blood glucose, San Diego drug developer Ligand Pharmaceuticals said Tuesday. The results open a path for further testing, and if all goes well, to approval of the drug…”

“Industry groups sue over Nevada drug price transparency law,” Reuters

“Two pharmaceutical industry trade groups have filed a lawsuit seeking to block a recently enacted Nevada law that requires manufacturers of diabetes medicines to report the costs of producing and marketing them. The Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization filed the lawsuit on Friday in federal court in Las Vegas, arguing the Nevada law is preempted by federal statute and is unconstitutional…”

“Novartis Calls the Doctor to Push Breakthrough Drugs Forward,” Bloomberg

“The last time Novartis AG hired a new chief, the drugmaker went with a guy who spent years at companies that make bleach and ketchup. This time around, the Swiss company chose someone with a deep understanding of treatments for heart failure, cancer, and the infectious diseases that plague poor countries. On Monday, Novartis said Vas Narasimhan, who rose through its ranks to become global head of drug development, will take the reins. As of February, he’ll replace Joe Jimenez, who had stints at Clorox Co. and ConAgra Foods Inc. before running the North American and then European operations of H.J. Heinz Co…”

“Was the big paper about the successful editing of human embryo genes wrong?” The Washington Post

“A month ago, an international team of researchers announced that they had used a gene-editing technique to safely erase a heritable heart condition from a human embryo. This blockbuster news was greeted with both excitement and fear. Now the scientific community is buzzing about a new critique that questions the main conclusions of their paper…”

Save