This week’s headlines include: Bayer, Novartis clash with UK doctors over use of cheap eye drug, Novartis bolsters oncology offering with $3.9bn deal, Insulin-releasing ‘smart cells’ could inspire new diabetes treatment, GSK gets boost for early cancer hopes with breakthrough status, and AbbVie says Humira sales will balloon to $21 billion in 2020, shares rise.

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

Managing Shear Stress in Biomanufacturing with the shear protectant Poloxamer 188 – A Discussion

We recently finished our Ask the Expert discussion, “Ask the Expert – Addressing Shear Stress in Bioreactors”. During this Ask the Expert session, we had questions that covered topics including factors that contribute to shear, analyzing and modeling shear stress in a bioreactor, and how to use a shear protectant to protect against shear. In addition, we had several questions related to Poloxamer 188 implementation, best practices, cell lines, qualification and media concentration level…

A Naturally Produced Extracellular Matrix that mimics stem cells’ native biochemical and structural microenvironment for improved performance

Cell and extracellular matrix interaction has been shown to play an important role in stem cell behavior and lineage differentiation, with cells’ microenvironment regulating many aspects of cell behavior…

Fed-batch culture – Optimizing feed strategies now and in the future

Great strides have been made in fed-batch culture and feed strategies with new tools and strategies introduced regularly. In addition to improving cell growth and viability, our optimization focus has grown to include strategies for influencing protein quality, such as glycosylation profiles. This article and accompanying interview will explore current feed design strategies and will look ahead to the future of fed-batch culture…

Ask the Expert – Going tiny is the next BIG thing: Tools and Techniques for Organoid Cultures

In the last decade, organoid cultures have quickly become a popular way to create “mini-organs” to support the advancements in the study of organogenesis, disease modeling and subsequently the development of new therapies. Scientists are creating lab-grown miniature versions of organs that so far include kidney, liver, brain, prostate and pancreas, that more closely resemble the composition and functionality of organs…

Enabling Antibody-drug conjugate manufacturing using single-use systems in downstream – Extractables study demonstrates a good fit

Antibody drug conjugates offer tremendous therapeutic potential and the market for ADCs is expected to expand rapidly. However, antibody-drug conjugate manufacturing presents both technological and logistical challenges…

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…

Events:

November

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:

“Bayer, Novartis clash with UK doctors over use of cheap eye drug,” Reuters

“Bayer is weighing legal action and Novartis has expressed concern at plans by doctors in the north of England to defy official guidance by using a cancer medicine as a cheap eye drug…”

“Novartis bolsters oncology offering with $3.9bn deal,” PharmaTimes

“Novartis has unveiled plans to buy Advanced Accelerator Applications (AAA) for $3.9 billion in cash, beefing up its oncology portfolio. Under the deal, Novartis will gain access to the firm’s Lutathera (177Lu-Dotatate), a first-in-class RadioLigand Therapy (RLT) approved in Europe in September for the treatment of unresectable or metastatic, progressive, well differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (NETs)…”

“Insulin-releasing ‘smart cells’ could inspire new diabetes treatment,” FierceBiotech

“Patients with Type 1 diabetes know the routine all too well: the frequent skin pricks to test their blood, the need for insulin injections or a mechanical pump to prevent dangerous spikes or drops in blood sugar. Scientists at University of North Carolina and NC State are developing what they hope will be a less painful, more convenient alternative: “smart” artificial beta cells that can detect the need for insulin and secrete it automatically…”

“GSK gets boost for early cancer hopes with breakthrough status,” Reuters

“GlaxoSmithKline received a boost for its oncology research on Thursday when an experimental drug for blood cancer received a “breakthrough” designation from U.S. regulators…”

“AbbVie says Humira sales will balloon to $21 billion in 2020, shares rise,” Reuters

“AbbVie Inc (ABBV.N) forecast its flagship drug Humira to bring $21 billion in sales by 2020, about $3 billion higher than its expectation two years ago, driving the U.S. drugmaker’s shares up 4 percent on Friday…”