The Dish’s Weekly Biotechnology News Wrap Up – March 9, 2018

This week’s headlines include: How One Child’s Sickle Cell Mutation Helped Protect the World From Malaria, Big pharma, big data: why drugmakers want your health records, JW Therapeutics, a China CAR-T biotech formed by Juno and WuXi, gains $90M series A, GlaxoSmithKline’s Fluarix protects young children in large phase 3 test, Biogen, AbbVie pull MS drug from the market, and Gottlieb to Health Insurers: Help Increase Biosimilar Competition.

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

cell-culture-dish-logo

Bovine Serum Albumin – More complex than you might think

Albumin is the one of the most abundant serum proteins found in plasma and is present in all mammals. Albumin is a complex protein that has many functions in the body including maintaining osmotic pressure of the circulatory system and binding a variety of molecules including toxins. It also binds and transports fatty acids. With these roles in vivo, it is logical that it would provide value in mammalian cell culture…

Novel 3D Cell Culture System Simplifies Tissue Culture Model Creation

The development of three-dimensional (3D) cell culture as a system to better model in vivo cytoarchitecture has been evident over the past several decades. Historically, flat, two-dimensional (2D) monolayer cells were the only practical option for cell-based screening and they have proven their utility for drug discovery. However, it is also evident that these 2D culture systems are limited in their ability to recapitulate normal tissue responses because they lack tissue-specific cytoarchitecture, in vivo mechanical and biochemical cues, and cell-to-cell and cell-to-matrix interactions…

3D Cell Culture Market Expected to Grow: As 3D Cell Culture Demonstrates Research Benefits

Cell culture is an important tool for research and development in the life sciences industry. While most researchers still rely on the conventional, two-dimensional (2D) cell culture method, the 3D cell culture model is gaining popularity among researchers in recent years due to the benefits this model offers over the conventional method…

Xeno-Free, what is it?

Cells are complex and intricate microscopic wonders that are now being recognized as having infinite potential as therapeutic agents to fight against devastating human disease. The Cell Therapy space is now rapidly growing in the pharmaceutical industry with accelerated efforts amongst the top biotech organizations to either acquire or internally develop and advance these agents through the developmental pipeline…


The Down Stream Column

Continuous Biomanufacturing Implementation Now and in the Future

In this podcast and accompanying article, we interviewed Dr. Peter Levison, Senior Marketing Director – Downstream Processing, Pall Biotech about the evolution and benefits of continuous biomanufacturing, what implementation looks like today and what still needs to be realized for full industry adoption…

Validation of Virus Filtration in Continuous Bioprocessing

Adoption of continuous processes certainly seems on the biomanufacturing horizon and this is not surprising considering the benefits of an integrated continuous approach. Demonstrated benefits include operational flexibility and efficiency, product consistency, increased quality assurance, and cost savings. However moving toward continuous bioprocessing requires the development of enabling technologies to support this type of operation…

Utilizing a Protein A Resin Platform Approach for Purification of Antibody Fragments and Single Domain Antibodies Reduces Process Time

Following the wave of successful commercial monoclonal antibody products, various forms of antibody fragments are now becoming an important class of next-generation therapeutic proteins. This includes Fabs and fusion proteins of the Fab variable domains. From the variable domain of the heavy-chain antibodies of camelids, the VHH sdAbs have been derived. These VHHs represent some of the smallest antigen binding antibody-derived proteins. As such they are more stable than full size mAbs, can be produced in microbial organisms, and offer higher target binding events per gram of product. Due to the lack of an Fc region, these antibody fragments cannot be captured with most engineered Protein A affinity ligands. However, Amsphere™ A3 Protein A ligand exhibits a high affinity for VHH single domain antibodies…

Addressing Challenges in Downstream Biomanufacturing with a platform purification approach

In this podcast and accompanying article, we interviewed Jonathan Royce, Business Leader, Chromatography Resins, GE Healthcare Life Sciences, about the biggest challenges in Downstream biomanufacturing including overcoming bottlenecks, changing antibody structures and bioburden control. Jonathan shared how a purification platform can address some of these issues and discusses purification challenges that still need to be resolved.


Conferences:

Stem Cell Community Day

The second international Stem Cell Community Day will take place on April 24, 2018 in Duesseldorf, Germany. The event brings together experts from industry and academia to discuss recent trends, achievements, and challenges in bioprocessing technologies for Stem Cell Research. The conference is organized by leading life science company Eppendorf AG.

In three sessions, the participants will discuss ways for establishing robust stem cell culture protocols, process strategies for obtaining commercial cell quantities, and challenges related to product purity. Professor Joaquim M. S. Cabral from the University of Lisbon will chair the conference. Dr. Robert Zweigerdt from Hannover Medical School and Karen Coopman, PhD from Loughborough University will present their latest findings in keynote lectures.

For more information, please see www.stemcellday.de

Webinars:

Advances in Aseptic Single-Use Fluid Handling and Management

Tuesday, March 13th, 2018 – 7:00 am PT, 10:00 am ET, 3:00 pm CET

Single-use technology has established itself as an integral part of the biomanufacturing process—helping to preserve space, increase flexibility, and save money. Thoughtful design for the handling and transfer of sterile liquids is a key consideration when designing single-use systems, and advances in equipment such as sterile connectors have facilitated many of these operations.  Assuring aseptic connections are reproducible and sterility is maintained during fluid transfer is underpinned by the design, materials of construction, and in-built quality of the connector. In addition, assessing the risk posed by leachables, which are potentially present in final drug product, is a regulatory requirement of biopharmaceutical manufacturers. Key to understanding the risk posed by leachables from single-use connectors is data based on agreed test methods, such as BPOG, that enables end users to make informed decisions on patient safety.

This new GEN webinar will explore Pall’s approach to incorporating user requirements in developing the Kleenpak® Presto sterile connector, the next generation genderless sterile connection technology for aseptic fluid handling and management in single-use biopharmaceutical manufacturing.

Single-Use-Systems: Leachable Study Design for Single-Use Components

Tuesday, March 20th, 2018 – 10 AM EST

The BPOG Leachables Working Group has recently published a Best Practice Guide for Leachables. The Best Practice Guide was developed to help Biopharmaceutical and Vaccines Manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of Single-Use Systems in manufacturing processes. The Best Practice Guide is composed of three parts: the risk assessment model, leachable study design, and analytical methods. This article provides insight into the application of the Best Practices for Leachables Study Design by end users and will include a case study to highlight the importance of the study design.

Podcasts:

Check out our podcast channel. We have 15 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more!

Click below to download through iTunes or Google play:

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Headlines:

“How One Child’s Sickle Cell Mutation Helped Protect the World From Malaria,” The New York Times

“The genetic mutation arose 7,300 years ago in just one person in West Africa, scientists reported on Thursday. Its advantage: a shield against rampant malaria…”

“Big pharma, big data: why drugmakers want your health records,” Reuters

“Drugmakers are racing to scoop up patient health records and strike deals with technology companies as big data analytics start to unlock a trove of information about how medicines perform in the real world…

“JW Therapeutics, a China CAR-T biotech formed by Juno and WuXi, gains $90M series A,” FierceBiotech

“Back in 2016, Juno Therapeutics (now owned by Celgene) and WuXi AppTec joined forces to create a new CAR-T biotech. Today, it got off a meaty $90 million series A with Chinese backing as it eyes clinical trials of its new cancer therapy…”

“GlaxoSmithKline’s Fluarix protects young children in large phase 3 test,” FiercePharma

“As a severe flu season continues to unfold in the U.S., GlaxoSmithKline is touting phase 3 study data showing its Fluarix Tetra can protect young children who are among the most vulnerable to the virus. In children six to 35 months of age, Glaxo’s vaccine was 63.2% effective against moderate-to-severe flu, and 49.8% effective against any flu, the company reported Tuesday, meeting its primary endpoint…”

“Biogen, AbbVie pull MS drug from the market,” PharmaTimes

“European regulators have started an “urgent review” of Biogen and Abbvie’s multiple sclerosis therapy Zinbryta following a stream of cases of serious inflammatory brain disorders in patients taking the drug…”

“Gottlieb to Health Insurers: Help Increase Biosimilar Competition,” Regulatory Focus

“Insurers need to do their part to help encourage biosimilar competition to bring down the rising prices of biologics, FDA Commissioner Scott Gottlieb told the America’s Health Insurance Plans’ (AHIP) National Health Policy Conference in Washington, DC, on Wednesday…”