This week’s headlines include: Europe follows FDA with plans to help early Alzheimer’s drugs, Flu Drug Approved in Japan Claims to Stop Virus in 24 Hours, Sangamo in $3 billion gene-editing deal with Gilead, Prokarium raises $10m for thermostable vaccines, Fate Therapeutics Wins $4M Grant to Advance NK Cancer Immunotherapy, Merck’s ERK inhibitor shows promise in combo against resistant cancers, and Diabetes is actually five separate diseases, research suggests.

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

The Cell Culture Dish’s Top Expert Discussions of 2017

This past year we had some excellent expert discussions through our Ask the Expert sessions and our Mini-webinar sessions. Topics include: upstream and downstream biomanufacturing, stem cell culture, Cell Therapy and drug discovery. I have listed our most Ask the Expert sessions and Mini-webinars here in alphabetical order…

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…

Corning® Nu-Serum™ I/IV Growth Medium Supplements for Reduced-serum Conditions with Fibroblast/Kidney Epithelial Cells

With the movement towards reduced-serum and serum-free conditions for cell culture, defined formulations and low-protein alterna­tives are of increasing value. Fetal bovine serum (FBS) is tradition­ally used as a supplement in media for cell and tissue culture at final concentrations of 5% to 10%. However, it can introduce risk as FBS lot-to-lot variation may negatively impact cellular and molec­ular studies, and can introduce artifacts due to the presence of unknown compounds, proteins, growth factors, and other unde­fined components¹. Additionally, the high protein content of serum can introduce complications with protein purification. Corning^® Nu-Serum™ growth medium supplements provide more cost-effective, low pro­tein alternatives that can be utilized as a 1:1 direct replacement for FBS in cell culture media…

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.

The Top 25 Downstream Column Blogs of 2017

I have compiled a list of our most popular 25 blogs, podcasts, and webinars for 2017 listed in alphabetical order…

Webinars:

Advances in Aseptic Single-Use Fluid Handling and Management

Tuesday, March 13^th, 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:

Headlines:

“Europe follows FDA with plans to help early Alzheimer’s drugs,” Reuters

“European regulators are following in the footsteps of the U.S. Food and Drug Administration with plans to help pharmaceutical companies win approval for novel Alzheimer’s drugs that treat the earliest stages of the memory-robbing disease…”

“Flu Drug Approved in Japan Claims to Stop Virus in 24 Hours,” The Scientist

“Health authorities in Japan on Friday (February 23) approved a new flu medication, called baloxavir marboxil (Xofluza), that aims to stop the virus within one day, according to The Wall Street Journal. The drug works by blocking the flu virus’s ability to use the host cell for replication. That’s a different mechanism from oseltamivir (Tamiflu), an anti-influenza medication available in the U.S. that works by blocking the virus’s neuraminidase enzyme, preventing its escape from the host cell…”

“Sangamo in $3 billion gene-editing deal with Gilead,” Reuters

“U.S. drugmaker Gilead Sciences Inc will use Sangamo Therapeutics Inc’s gene-editing technology to develop cancer treatments in a deal potentially worth about $3 billion to Sangamo, the companies said on Thursday…”

“Prokarium raises $10m for thermostable vaccines,” PharmaTimes

“UK-based synthetic biology firm Prokarium has secured $10 million from Saudi, Swedish and Korean investors to help drive clinical development of thermostable vaccines. The new funds will enable the clinical development of groundbreaking vaccines against Chlamydia, C.difficile and enteric fever (typhoid and paratyphoid), as well as the expansion of its team for R&D in immuno-oncology…”

“Fate Therapeutics Wins $4M Grant to Advance NK Cancer Immunotherapy,” Genetic Engineering News

“Fate Therapeutics said today it has won a $4 million California Institute for Regenerative Medicine (CIRM) grant toward advancing one of its off-the-shelf engineered natural killer (NK) cell cancer immunotherapies into a first-in-human clinical trial…”

“Merck’s ERK inhibitor shows promise in combo against resistant cancers,” FierceBiotech

“One-fifth of patients in a phase 1 study responded to an investigational ERK inhibitor from Merck, bolstering hopes that this type of drug could be used effectively in combination with other cancer drugs. ERK is a cell signal that is believed to drive the growth of many cancers…”

“Diabetes is actually five separate diseases, research suggests,” BBC News

“Scientists say diabetes is five separate diseases, and treatment could be tailored to each form. Diabetes – or uncontrolled blood sugar levels – is normally split into type 1 and type 2. But researchers in Sweden and Finland think the more complicated picture they have uncovered will usher in an era of personalised medicine for diabetes. Experts said the study was a herald of the future of diabetes care but changes to treatment would not be immediate…”