This week’s headlines include: Immunotherapy Drugs Slow Skin Cancer That Has Spread to the Brain, Novartis’ PI3K drug hits goal in phase 3 breast cancer trial, laying groundwork for talks with regulators, Congo approves 4 experimental Ebola treatments in outbreak, FDA extends EpiPen expiry date to combat shortage, Scientists Race To Improve ‘Living Drugs’ To Fight Cancer, and Exosomes from Cancer Cells Could Predict Immunotherapy Responses.

Headlines:

“FDA Approves New Drug For Hepatitis A And Measles Exposure,” Forbes

“The US Food and Drug Administration (FDA) has approved a new drug for people who have been exposed to measles and hepatitis A viruses. This could be especially good news for older adults who are more likely to suffer from weakened immune systems and thus have more difficulty fighting off infections…”

“Vaccines Against H.I.V., Malaria and Tuberculosis Unlikely, Study Says,” The New York Times

“Vaccines against H.I.V., malaria and tuberculosis — three major killers of the world’s poor — are unlikely to be produced in the foreseeable future unless vastly more money is committed to finding them, a new study has concluded. Other worthy goals that appear out of reach for now include a hepatitis C vaccine, a combination vaccine against the four leading causes of deadly diarrhea, a rapid cure for people who have caught tuberculosis and new treatments for a dozen neglected diseases, such as leprosy, dengue fever and sleeping sickness…”

“AstraZeneca, Amgen’s tezepelumab wins ‘breakthrough’ status,” PharmaTimes

“AstraZeneca and Amgen’s tezepelumab has won breakthrough therapy status in the US for its potential to treat severe asthma without an eosinophilic phenotype. The therapy is being developed for use in patients who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers…”

“Merck KGaA, Pfizer’s immuno-drug shown to alleviate kidney cancer,” Reuters

“Merck KGaA said that its immunotherapy Bavencio, jointly developed with Pfizer, delayed the progression of kidney cancer when used in combination with Pfizer’s Inlyta drug in a late-stage study. The drug combination led to longer progression-free survival in patients with advanced renal cell carcinoma (RCC) when compared with a control group on older Pfizer drug Sutent, the German drugmaker said in a statement on Tuesday…”

“CRISPR Therapeutics, Vertex start first company-backed human CRISPR trial,” FierceBiotech

“While research groups in China have already started testing CRISPR in humans, CRISPR Therapeutics and Vertex Pharmaceuticals are the first companies to sponsor a human trial of the gene editing technology. The trial will take place at a single site in Germany and will test a gene therapy in patients with beta thalassemia…”

“Duchenne Muscular Dystrophy Mutation in Dogs Reversed by CRISPR-Cas9,” Genetic Engineering News

“CRISPR-Cas9 has, for the first time, been tested by systemic delivery in a large animal—and the results are striking. Working in a dog model of Duchenne muscular dystrophy (DMD), the gene editing not only restored the expression of the protein dystrophin, it also improved muscle histology in the dogs…”

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

Key Considerations for Gene Therapy Commercialization

Gene therapy is the use of a gene-modifying technology to repair, replace or correct damage in the body. The first approved gene therapy study was conducted by the National Institutes of Health (NIH) in 1989 and provided evidence for the first time that human cells could be genetically modified and returned to the patient without harm. To date, approximately 2,600 clinical trials and six gene therapy products have been approved in various countries…

The Next Evolution in Stem Cell Culture™: Cell-Derived Extracellular Matrices

The interaction between cells and the extracellular matrices they are cultured on is extensive. In standard cell culture, cells are pulled from tissue, which provides a native extracellular matrix and are put onto tissue culture treated plastic. While most cells will ultimately adhere and grow on tissue culture treated plastic, their gene expression and proliferation is often different from in vivo…

The Impact of Trace Elements on Cell Culture Media and Upstream Processing

Despite the high efficacy and target specificity of biopharmaceutical drugs, there are still multiple challenges associated with achieving efficient production of therapeutic proteins. These include discovering new approaches for maximum protein expression, developing economical, flexible and robust manufacturing processes to maximize product yields, and solving the complex challenges of refolding proteins into their active state…

Opportunities for Leveraging Biomedical Innovations in the Development of the Clean Meat Industry

Motivated by an interest in alleviating the immense environmental impact of intensive animal agriculture, the past two years have witnessed a surge in efforts to develop bioengineered products that directly replicate the cellular composition of meat. This wouldn’t be the first time technology developed in biomedicine has made the leap to the food industry. As demonstrated by the successful cross-application of recombinant protein production technology from human insulin synthesis to widespread food enzyme and ingredient production, the potential to revolutionize food product development with biomedical research is significant but largely unexplored. Scientists are now beginning to tap into this potential by utilizing animal cell culture advancements to make products that are referred to as clean meat because they are free of the environmental, public health, and animal welfare consequences of animal rearing, slaughter, and antibiotic use…

Increasing Process Development Workflow Efficiency by Integrating High Throughput Technologies

A strategy for increasing process development workflow efficiency by incorporating enabling high throughput technologies including ambr™ bioreactors, the Cedex™ Bio HT Analyzer, Sm@rtline Data Cockpit , and the Tecan Fluent™ pipetting robot. During this year’s PepTalk conference, there was a very impressive presentation given by Dr. Timo Frensing, Large Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Munich. The title of the talk was “Integration of high throughput systems into the USP development workflow and into the data acquisition, management and analysis system.” In the talk, Dr. Frensing described how his team was able to increase process development workflow efficiency through the incorporation of several enabling high throughput technologies…

How Robots Are Changing The Landscape Of The Medical Field

Robotics are becoming increasingly present in many different industries. In the medical world, robots and AI are helping medical professionals conduct procedures, understand the risk of surgical complications, and provide more precise patient care….

Continuous biomanufacturing – Key drivers for adoption, economic modelling and regulatory considerations

The Medicine Maker recently published a multi-authored eBook on Continuous Biomanufacturing, titled, “The Continuous Way”. The publication includes seven articles covering the topic of continuous biomanufacturing from a variety of angles. I really enjoyed the eBook and it provided a great update on the current state of continuous biomanufacturing as well as information about key drivers for adoption, new economic modeling, and integration of continuous operations. Following is a sampling of articles with key highlights…

Cool Tool – Inline Diafiltration Closes the Gap for End-to-End Continuous Bioprocessing

Diafiltration, while fulfilling several functions in protein purification, has also presented a major obstacle in achieving continuous biomanufacturing. Technologies launched over the last decade have moved the industry closer to completing an integrated end-to-end continuous bioprocessing platform; however adequately addressing continuous final ultrafiltration/diafiltration of drug substance has been challenging. Now, inline diafiltration offers a solution to both traditional bottleneck hurdles and continuous biomanufacturing platform gaps…

Start With the End in Mind – How to facilitate transfer from non-GMP to GMP Manufacturing

In this podcast and accompanying article, we interviewed Avril Vermunt, bioprocess hardware specialist at GE healthcare about transferring a process from non-GMP to GMP manufacturing, particularly how resource-intensive it is for process development and manufacturing groups. Avril has several years of experience working in the technology transfer group at a large pharmaceutical company. We discussed with her best practices and how being proactive and one step ahead can make the process more seamless…

Webinars

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