This week’s headlines include: FDA Withdraws Draft Guidance on Biosimilar Development, Novartis to Spin Off Alcon as CEO Focuses on Finding Drugs, How Long Can We Live? The Limit Hasn’t Been Reached, Study Finds, Arming antibiotics with a vaccination-like immune response, Stem Cells Renew Heart Function in Primates with Cardiac Failure, and Ketogenic Diet Improves Response To Cancer Drug In Mice, But Alone May Accelerate Cancer.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Last month’s ISCT conference held in Montreal, Canada featured many novel approaches for cell therapy research and manufacturing. One of the posters presented at the conference, “Inclusion of Recombinant Albumin and Transferrin Enables the Blood-Free Expansion of Mesenchymal Stem Cells in Chemically Defined Media,” highlighted the importance of blood-component free media for cell therapies and provided data on the use of a blood-free media in mesenchymal stem cell (MSC) culture…
With initial data from the 2017-2018 flu season indicating around 20% better protection from the cell culture manufactured Flucelvax flu vaccine, will the industry begin to move away from eggs and toward cell based influenza vaccines? Seven years ago I wrote an article called, “Is Egg-based vaccine manufacturing on its way out”. Since then there have been two cell based influenza vaccines approved for use in the United States, Flucelvax manufactured in MDCK cells by Seqirus and FluBlok manufactured in insect cells from Sanofi. However, the vast majority of the vaccines administered in the United States still use egg-based manufacturing. This trend may change in coming years, as there has been increasing interest in moving from egg-based vaccine manufacturing to cell culture-based methods. Cell based vaccine manufacturing is quicker, efficiently scalable and offers more control over the manufacturing environment. There is also the potential for fewer virus mutations and thus a more effective vaccine…
PhD and post-doc cancer researchers are being recognized as cell culture heroes in a new program that provides a platform to promote education and share knowledge among the researchers who are driving breakthroughs in the fight against cancer.
Cancer is defined as a disease caused by an uncontrolled division of abnormal cells that can affect any part of the body, with well over 200 different types of cancer identified to date. It is one of the world’s biggest killers, with approximately 14 million new cases and 8.2 million deaths a year…
Informa’s Cell Line Development and Engineering conference last month was full of pharmaceutical companies and solutions providers sharing best practices, innovative solutions and emerging trends in Cell Line Development. I was pleased to attend the conference and wanted to share some highlights…
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…
In this podcast and accompanying article we interviewed Dr. Yuyi Shen, Principal Scientist, Grifols about the benefits of modeling downstream disruptive technologies to improve downstream bioprocessing and evaluating the financial impact of implementing these technologies…
Impurity precipitation is focused on process- and product-related impurities which have to be removed during the downstream process in the manufacturing of therapeutic proteins. Common impurities are host cell proteins, DNA as well as aggregates of the therapeutic protein. Moreover, the purification process must include steps which are able to inactivate or remove viruses to ensure the viral safety of the biopharmaceutical…
Continuous bioprocessing presents many exciting opportunities for improving biomanufacturing. Frequently discussed are methods for incorporating Process Analytical Technology (PAT) initiatives into a continuous operation. One advantage of implementing PAT in continuous bioprocessing operations is the opportunity to not just analyze what has happened, but to make real-time process control adjustments for increased quality assurance and greater process efficiency…
Cell Culture Heroes – Webinars on Cancer Research
Gibco Cell Culture Heroes spotlights PhD and post-doc cancer researchers across the globe with the primary focus of telling the story of their research. This program promotes education and creates a community amongst researchers who are driving tomorrow’s breakthroughs in the fight against cancer.
As a Gibco Cell Culture Hero you can present your research to a global audience via webinar and you will have the opportunity to share your story of success and perseverance to the world on thermofisher.com.
Do you want your research to be highlighted as a Cell Culture Hero? Click here to learn more – https://www.thermofisher.com/us/en/home/products-and-services/promotions/life-science/cell-culture-heroes.html
Bringing together 300+ leaders and key influencers from pharma and biotech companies this September in Boston, Cell & Gene Therapy Bioprocessing & Commercialization 2018 will provide you with the latest advice for driving manufacturing and commercialization through direct access to innovative discovery, product development and regulatory know-how. Discover everything you need in one place as you move between 4 tracks jam packed with topical talks and industry case studies, and meet with colleagues for an unrivalled on-site experience.
Check out our podcast channel. We have over 20 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:
“The U.S. Food and Drug Administration (FDA) withdrew its draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars. The guidance “Statistical Approaches to Evaluate Analytical Similarity” was initially issued in September 2017. The FDA withdrew the draft guidance on June 21. The guidance was intended to provide advice for biosimilar developers regarding the “evaluation of analytical similarity between a proposed biosimilar product and a reference product,” the FDA said. The FDA withdrew its guidance following public input that expressed some concerns. One of the filers was Sarfaraz K. Niazi, an adjunct professor specializing in biosimilar development at the University of Illinois and the founder of Pharmaceutical Scientist, Inc., a consulting company. In his petition, Niazi said the FDA should waive bridging studies for qualified non-US comparators and encouraging payers to reimburse only for biosimilars when prescribed for new patients…”
“Less than halfway through his first year as chief executive officer of Novartis AG, Vas Narasimhan plans a third major transaction to narrow its focus on developing cutting-edge medicines.The Swiss drugmaker said Friday that it will spin off its Alcon eye-care unit while using proceeds from the $13 billion sale of its stake in a consumer-health joint venture with GlaxoSmithKline Plc, announced in March, to repurchase as much as $5 billion in shares…”
“Since 1900, average life expectancy around the globe has more than doubled, thanks to better public health, sanitation and food supplies. But a new study of long-lived Italians indicates that we have yet to reach the upper bound of human longevity…”
“Harnessing the power of the body’s immune system has already proven to be effective in treating cancer. Scientists at Lehigh University are now borrowing that idea to power up existing antibiotics’ ability to attack drug-resistant bacteria…”
“Researchers at the University of Washington, Seattle, have used human embryonic stem cell–derived cardiomyocytes (hESC-CMs) to restore heart function in macaque monkeys with heart failure. The researchers hope that their achievement could pave the way for development of a similar treatment for human patients…”
“Mice on a ketogenic diet have shown remarkable responses to a class of cancer drug, which has previously experienced largely underwhelming results in human clinical trials. The study published today in Nature shows how the combination of a ketogenic diet with a type of cancer drug called a PI3K inhibitor strongly improves the effect of the drug in mouse models of cancer…”