The Dish’s Weekly Biotechnology News Wrap Up – July 27, 2018

This week’s headlines include: Eisai-Biogen to advance Alzheimer’s drug, provide fresh hope, Pfizer bags approval for Neupogen biosimilar, Trump administration to explore drug imports to counter price hikes, Ebola Outbreak in Congo Has Ended, W.H.O. Says, Using Zika virus to treat neuroblastoma in children, Got Milk? Roche to Apply PureTech Exosomes Platform in $1B+ Collaboration, and Think AbbVie can’t live without Humira? Check out Tuesday’s blockbuster Orilissa nod.

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

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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…

Expansion of Mesenchymal Stem Cells in Blood-free, Chemically Defined Media

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…

Cell Based Influenza Vaccines – Are eggs finally on the way out?

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…

Knowledge Sharing is Key to Future Breakthroughs in Cancer Research

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…


The Down Stream Column

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…

Modeling Downstream Disruptive Technologies to Improve Downstream Bioprocessing

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…


Webinars

Next Generation Processes: What Model Works Best in Asia?

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

View the on-demand webinars of current Cell Culture Heroes


Conferences:

BioProcess International Conference and Exhibition – September 4-September 7, 2018

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.

Cell & Gene Therapy Bioprocessing & Commercialization – September 4 – September 7, 2018

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.

Podcasts:

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:
Available on Google PlayAvailable on itunes


Headlines:

“Eisai Co Ltd and Biogen Inc will move forward with late-stage clinical trials of their Alzheimer’s disease drug, BAN2401, and are working with regulators to design the next studies and gain expedited review as a breakthrough therapy…”

“Pfizer’s Neupogen biosimilar Nivestym has been approved by the US Food and Drug Administration and is expected to hit the market at a “significant discount” to its reference drug. The white blood cell stimulator will be available for all eligible indications of Amgen’s Neupogen (filgrastim), such as decreasing the incidence of infection in some cancer patients, after showing “a high degree of similarity” in clinical trials, the drug giant said….”

“Trump administration to explore drug imports to counter price hikes,” The Washington Post

“The Trump administration is cracking open the door to using prescription drugs imported from overseas — ones that have not been approved by the Food and Drug Administration — to combat high drug prices in limited circumstances. The FDA said Thursday that it plans to create a working group to examine how to safely import drugs in a specific situation: when there’s a sharp price increase for an off-patent drug produced by a single manufacturer…”

“The outbreak, the first in which a new vaccine was quickly rolled out, was extinguished in less than three months, with 33 deaths…”

“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…”

“Got Milk? Roche to Apply PureTech Exosomes Platform in $1B+ Collaboration,” Genetic Engineering News

“Roche will work to enable oral administration of its antisense oligonucleotide platform using PureTech Health’s milk-derived exosome technology, through a collaboration that PureTech said today could generate for it more than $1 billion. Under the multi-year collaboration, Roche will study applying PureTech’s milk exosomes technology, which is designed to facilitate oral delivery of macromolecules such as nucleic acids and peptides, as well as complex small molecules…”

“Think AbbVie can’t live without Humira? Check out Tuesday’s blockbuster Orilissa nod,” FiercePharma

“One of AbbVie’s most highly anticipated pipeline candidates has reached the regulatory finish line. On Tuesday, the FDA approved Orilissa, a treatment for pain associated with endometriosis—and a potential blockbuster contributor to AbbVie’s life after Humira biosimilars hit…”