This week’s headlines include: Severe pediatric asthma drug wins European panel thumbs-up, Single Enzyme Defects: FDA Drafts Guidance to Help Drug Developers, Federal government renews $15 million in funding for Toronto’s booming regenerative medicine cluster, Lung cell discovery opens new route for cystic fibrosis treatment, Obesity Affects Flu Transmission Rates, and Some Bacteria Are Becoming ‘More Tolerant’ Of Hand Sanitizers, Study Finds.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
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…
Closed System Cell Therapy Manufacturing – Moving from the lab to clinical and commercial production
In this podcast, we conducted a panel discussion on key considerations for moving cell therapies from lab to commercial manufacturing, including the benefits of manufacturing in a closed system. We also discussed what were some of the key hurdles and possible solutions associated with transitioning to clinical and commercial cell therapy manufacturing…
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…
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…
August 9, 2018 -10:30AM IST
Compare and contrast the available full scale processing technologies, and discover what works the best for manufacturing next generation therapeutic products in Asia.
Biologics are complex and hard to make, which helps to explain why biotech manufacturing plants are huge and expensive to build. To be competitive, manufacturing must be efficient and cost-effective and should brainstorm economical ways to manufacture biologics.
Biosimilars are a cost competitive market. Pricing may have a direct impact on market share, and return on investment. The market for biologics, including approved and in pipeline like ADCs, antibodies & antibody fragments present both tremendous opportunity and challenge. Challenges necessitates looking beyond the current platform philosophy for how to modify the process with a goal to increase overall productivity in a flexible manner.
The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for manufacturing next generation therapeutic products in Asia.
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:
“GlaxoSmithKline drug Nucala has won a key recommendation from a European Medicines Agency (EMA) panel for use in the treatment of children with severe asthma, the company said in a statement on Friday….”
“The US Food and Drug Administration (FDA) on Thursday released draft guidance to help sponsors understand the evidence necessary to demonstrate the effectiveness of new drugs, including biologics, or new drug uses intended for slowly progressive, low-prevalence rare diseases that are associated with substrate deposition and are caused by single enzyme defects…”
“Federal government renews $15 million in funding for Toronto’s booming regenerative medicine cluster,” University of Toronto News
“The federal government is renewing $15 million in funding for the commercialization heart of Toronto’s growing regenerative medicine community. Announced today by federal Science Minister Kirsty Duncan, the funding for the Centre for the Commercialization of Regenerative Medicine (CCRM) will be delivered through the Networks of Centres of Excellence (NCE) program…”
“Scientists already know cystic fibrosis is caused by mutations in the gene they call cystic fibrosis transmembrane conductance regulator (CFTR), but they didn’t know where expression of the gene is active in the body. Using novel sequencing technologies, two separate teams have now discovered a rare cell type in airway tissue that appears to play a key role in the genetic disorder…”
“In addition to obesity’s known impact on flu severity—complications including hospitalization and even death—new findings from investigators at the University of Michigan School of Public Health suggest that obesity may play a significant role in the transmission of the influenza virus. Findings from the new study, published today in The Journal of Infectious Diseases through an article titled “Obesity Increases the Duration of Influenza A Virus Shedding in Adults,” suggests that obese adults infected with flu shed the virus for a longer time than adults who are not obese, potentially increasing the opportunity for the infection to spread to others…”
“In the early 2000s, hospitals across Australia began installing more hand-sanitizer dispensers in their rooms and hallways for staff, visitors and patients to use. Research showed these alcohol-based disinfectants helped battle staph infections in patients and certain kinds of drug-resistant bacteria. And rates of these infections went down…”