This week’s headlines include: Bluebird, Regeneron Team Up To Make Cell Therapies For Cancer, Pfizer pays BioNTech $120M upfront to form mRNA flu vaccine pact, Mustang Bio and St. Jude Children’s Research agree to develop gene therapy, Orchard raises $150 million to expand after GSK gene therapy deal, Antibodies May Prove to Be Promising Therapeutics against Ebola, and Alnylam’s gene silencing drug wins FDA approval.

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

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…

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…

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

Cell Culture Heroes – Webinars on Cancer Research

Conferences:

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

The Largest Exhibition Devoted to Biomanufacturing

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:

Headlines:

“Regeneron Pharmaceuticals and Bluebird Bio have struck a wide-ranging partnership to broaden the reach of their respective cancer immunotherapy work, inking a deal to develop multiple cell therapies together….”

“Pfizer has struck a $425 million deal to work with BioNTech on the development of mRNA influenza vaccines. The Big Pharma is providing $120 million in upfront and near-term payments to enter into the R&D collaboration. Germany’s BioNTech has established itself at the forefront of the mRNA field, leading to deals with Eli Lilly, Genentech and Sanofi and a $270 million series A. Many of the collaborations, plus BioNTech’s internal programs, are using mRNA to activate the immune system against tumors. But the approach could also yield prophylactic vaccines that are more potent and easier to make than existing shots…”

“Anglo-American biotech company Orchard Therapeutics has raised a further $150 million to fund its work in gene therapy, building on earlier fundraisings worth more than $140 million…”

“An international team of scientists reports that therapeutic antibodies may be the best way to stop the Ebola virus. Their study (“Systematic analysis of monoclonal antibodies against Ebola virus GP defines features that contribute to protection”), published in Cell, suggests new therapies should disable the Ebola virus’s infection machinery and spark the patient’s immune system to fight the virus…”

“Alnylam’s gene silencing drug wins FDA approval,” Reuters

“Alnylam Pharmaceuticals Inc’s drug for a rare hereditary disease won U.S. regulatory approval on Friday, becoming the first approved treatment from a new class of medicines that use gene silencing technology. Onpattro, also known as patisiran, will have an annual U.S. list price of $450,000 for the average patient, the company said. The drug, which is dosed based on patient weight, was approved to treat polyneuropathy in patients with hereditary ATTR amyloidosis, a potentially fatal condition that affects an estimated 50,000 people worldwide…”