This week’s headlines include: Drug to Treat Smallpox Approved by F.D.A., a Move Against Bioterrorism, Genentech Flu Drug Scores Another Late-Stage Win, FDA Aims to Facilitate Gene Therapy Development for Hemophilia, Rare Diseases, Catalent Biologics Adopts Berkeley Lights’ Beacon® Optofluidic Platform to Accelerate Cell Line Development, Spero nets $54M biodefense R&D contract for its lead antibiotic, Pfizer kicks off PhIII programme for haemophilia B gene therapy, and Roche’s Tecentriq extends its hot streak with liver cancer combo breakthrough.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Cool Tool – Intelligently Designed Cell Culture Dishes Address Common Cell Culture Scientists’ Complaints
Who hasn’t been in the lab and accidently bumped one of their cell culture dishes, spilling the precious contents? Or has struggled to grip a dish with gloved hands? Well most people don’t think of cultureware, especially cell culture dishes, as being particularly innovative, but there is a new cell culture dish…
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…
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…
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…
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…
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
The Largest Exhibition Devoted to Biomanufacturing
Capitalize on 225+ case studies and new data presentations from global thought leaders to improve integration, productivity and cost savings across the entire bioprocessing spectrum.
Grab your 3-day exhibit hall pass to BPI Boston, held September 5-7 at the Hynes Convention Center. Exhibit hall passes start at $449, but register with VIP code DISH by July 27 and save an extra $100.
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 Food and Drug Administration on Friday approved the first drug intended to treat smallpox — a move that could halt a lethal pandemic if the virus were to be released as a terrorist bioweapon or through a laboratory accident…”
“With flu season fast approaching, Genentech has some good news for people who are at high risk of complications from the illness. The South San Francisco-based company said its late-stage therapy for that patient population was faster at helping those patients recover from the effects of the illness than placebo…”
“FDA Aims to Facilitate Gene Therapy Development for Hemophilia, Rare Diseases,” Specialty Pharmacy Times
“Significant progress has been made in gene therapy research and development over the years, with promise to treat and cure some of the most complex diseases. In a statement, FDA Commissioner Scott Gottlieb, MD, announced the agency’s latest efforts to speed up the path to approval for gene therapies, specifically for certain specialty and rare diseases…”
“Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Berkeley Lights, Inc. (BLI), a leader in digital cell biology, today announced Catalent Biologics will adopt BLI’s Beacon® optofluidic platform to accelerate its cell line development workflow…”
“Antibiotic developer and former Fierce 15 winner Spero Therapeutics has received $15.7 million in federal research funding for its oral carbapenem-class candidate, SPR994, which will be the subject of an interagency collaboration to evaluate the drug’s effectiveness against biological threats, including anthrax, plague and melioidosis…”
“Pfizer has kicked off a late-stage trial assessing efficacy and safety of the investigational gene therapy fidanacogene elaparvovec for the treatment of haemophilia B. The Phase III lead-in study has been initiated following completion of the transfer of Spark’s haemophilia B programme to the drug giant…”
“On Tuesday, the immuno-oncology drug—in combination with Roche’s Avastin—picked up a breakthrough therapy designation from the FDA in previously untreated liver cancer patients, putting it on the path to a speedy approval. The agency based the decision on phase 1b data, presented at last month’s American Society of Clinical Oncology annual meeting, that showed the Tecentriq-Avastin pairing could provoke a response in 65% of study patients at a median 10.3 months of follow-up…”