This week’s headlines include: AbbVie Launches, Biogen Tweaks Alzheimer’s Collaborations, BioMarin’s Gene Therapy for Hemophilia A Continues to Impress, Ventria Wins $4.2M Gates Foundation Grant toward Biomanufacturing ETEC Therapeutics, The Long War on Polio, as Recalled by Its Generals, Biogen takes up option to co-develop Eisai AD drug, and Will FDA Add Suffixes to Approved Biologics’ Names?

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

Do you have to sacrifice antibody titer for quality? Employing cell biology to get the best of both worlds

In this podcast and accompanying article, we interviewed Dr. Adam Elhofy, Ph.D., Chief Scientific Officer, Bio-Ess Laboratories, about the relationship between antibody titer and product quality attributes such as glycosylation. Dr. Elhofy shares his thoughts on both challenges and opportunities in optimizing for both high titer and glycosylation profiles…

FDA Approves First CAR T-Cell Therapy – The evolution of CAR T-Cell Therapy

Cancer treatment has historically relied on what are called the three pillars of oncology: operation, chemotherapy, and radiotherapy. With recent advances in cancer immunotherapy, where the body’s immune system to used to treat cancer, it is being touted as the fourth pillar of oncology. The US FDA’s (Food and Drug Administration) approval of Kymriah™―developed by Novartis©―in August 2017 has cemented this idea. Kymriah™ is the first chimeric antigen receptor (CAR) T Cell Therapy approved to treat disease in the United States. This CD-19 targeted CAR-T therapy is for patients under the age of 25 who have refractory or relapsed (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb…

Ask the Expert – Addressing Shear Stress in Bioreactors

Introduction of oxygen to cell culture media via sparging is critical for efficient bioreactor operation. Since oxygen is sparingly soluble in culture media, efficient sparging methods are important to ensure cells have enough oxygen for growth and productivity. However, hydrodynamic stress in bioreactors and specifically shear caused by sparging, can present a challenging issue in commercial biopharmaceutical manufacturing…

Cool Tool – Improved, High Quality Poloxamer 188 Produces Consistent Performance in Cell Culture

Hydrodynamic stress in bioreactors and specifically shear caused by sparging can present a challenging issue in commercial biopharmaceutical manufacturing. A solution was found in the use of Poloxamer 188, a surface-active, non-ionic polymer that when added to cell culture media acted as a shear protectant. Poloxamer 188 became a standard ingredient in cell culture media for commercial production…

2017 Biotech Week Boston – Downstream Coverage Highlights

Last month, Boston Biotech Week featured interesting content with a wide range of issues, from cell culture techniques to commercialization and everything in between covered. Talks focused on improving the manufacturing process for biopharmaceuticals and cell therapies, enabled industry networking opportunities, and provided the chance to see the latest products and technologies…

Cool Tool – Optimize downstream processing with single-pass inline concentration

Concentration of biological drug substances is an important step at various stages in biomanufacturing. Concentration is often necessary between chromatography steps, in post harvest, during pre-capture or for in-process volume reduction. Concentration may also be needed between chromatography steps.

During concentration applications, there is a potential for aggregation, particularly with sensitive biologics even when they are only slightly stressed. Therefore, an effective concentration system must operate efficiently under mild conditions while at the same time being flexible enough to integrate readily with different downstream operations…

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…

Events:

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:

“AbbVie Launches, Biogen Tweaks Alzheimer’s Collaborations,” Genetic Engineering News

“Development of new Alzheimer’s disease treatments is the focus of separate collaboration agreements announced today by AbbVie and Biogen. AbbVie and Alector said they plan to develop and commercialize therapies to treat Alzheimer’s and other neurodegenerative disorders using the latter’s immuno-neurology drug discovery tech platform, through a collaboration that could generate up to $225 million for Alector…”

“BioMarin’s Gene Therapy for Hemophilia A Continues to Impress,” Rare Disease Report

“The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Biomarin’s Gene Therapy for hemophilia A, valoctocogene roxaparvovec (formerly BMN 270). Breakthrough Therapy Designation allows the FDA to expedite the development and review of the Gene Therapy. The special designation was given based on preliminary clinical evidence of the drug’s ability to provide ‘substantial improvement over existing therapies’…”

“Ventria Wins $4.2M Gates Foundation Grant toward Biomanufacturing ETEC Therapeutics,” Genetic Engineering News

“Ventria Bioscience said today it has won a $4.2 million grant from the Bill & Melinda Gates Foundation toward the biomanufacturing of new therapeutics targeting enterotoxigenic Escherichia coli (ETEC). Ventria said the grant will enable it to develop its ExpressTec technology platform for producing potential ETEC treatments…”

“The Long War on Polio, as Recalled by Its Generals,” The New York Times

“Coffee With Polio Experts” will not be picked up by Hulu anytime soon, but there is something compelling in these short videos put out by the Global Polio Eradication Initiative. The formula is simple: Doctors who have spent years fighting polio in the world’s most remote regions sit down over coffee with a World Health Organization representative to tell war stories…”

“Biogen takes up option to co-develop Eisai AD drug,” PharmaTimes

“Biogen and Eisai have expanded their existing collaboration agreement to develop and commercialise investigational therapies for Alzheimer’s Disease. Eisai has taken up its option to co-develop and co-promote aducanumab, Biogen’s investigational anti-amyloid beta antibody for AD patients…”

“Will FDA Add Suffixes to Approved Biologics’ Names?” Regulatory Focus

“Back in January, the US Food and Drug Administration (FDA) finalized guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name…”