This week’s headlines include: Medigene gets OK for first trial of T-cell receptor therapy, Mesoblast stem Cell Therapy meets goal of pediatric Graft vs. Host study, Gilead wins reversal of $2.54 bln hepatitis C drug patent verdict, U.S. health officials reverse stance on AstraZeneca’s flu vaccine, and In mice, a single vaccine prompts the immune system to fight breast, lung and skin cancers.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
This past year we really got our podcast channel going with several great podcasts on upstream and downstream biomanufacturing, stem cell culture, Cell Therapy and drug discovery. We always include interesting show notes and the option of listening from your computer, so please check these out, even if you don’t want to download to a mobile device. I have listed our most popular podcasts here in alphabetical order…
pH is one of the most important parameters in maintaining a healthy cell culture. This week’s Two Minute Tuesday educational video is the first of a three part series of interviews with Dr. Robert Garrahy, Vice President of Bioprocess Technologies at Broadley-James Corporation. Dr. Garrahy is interviewed about the most important selection factors in pH probes, as well as important cleaning and maintenance recommendations…
We recently finished our Ask the Expert discussion on “Cancer Research.” During this Ask the Expert session, we covered topics related to innovative tools and methods in cancer research. One of the topics explored was the use of spheroids and organoids and enabling technologies for cancer research. There were also several discussions around the culture of various cancer cell types, including medium and extracellular matrices choices. There was a very interesting question about new tools that are in development to aid in cancer research…
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…
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…
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.
I have compiled a list of our most popular 25 blogs, podcasts, and webinars for 2017 listed in alphabetical order…
In this podcast and accompanying article, we interviewed Jonathan Royce, Business Leader, Chromatography Resins, GE Healthcare Life Sciences, about the evolution of Protein A including the latest developments in Protein A chromatography resins. We also discussed what the future holds for this purification mainstay and how it can continue to address the changing needs of biopharma…
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
Thursday, March 1st, 16:00- 16:45 GMT
With over 40 years combined experience, Purolite Life Sciences’ Global Applications Director (Agarose), Hans Johansson and eXmoor Pharma Bioprocess Engineer, Dr David Vincent will present a case study that looks at the purification performance of different base matrices, and protein A ligands to support the concept of dual sourcing. The webinar will also discuss some of the production challenges that may face the Cell and Gene Therapy industry, as an increasing number of products are scaled up and out.
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.
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:
“Medigene has been given a green light by regulators in Germany to start human trials of MDG1011, the lead candidate to come out of its modified T-cell program. The Munich-based biotech says it will start a combined phase 1/2 safety and feasibility trial of the T-cell receptor (TCR) cancer immunotherapy in about 92 patients with acute myeloid leukemia (AML), myelodysplastic syndrome or multiple myeloma “within the coming weeks.”
“Nearly 70 percent of children with potentially fatal acute Graft Versus Host Disease responded to treatment with an experimental stem Cell Therapy from Mesoblast Ltd, meeting the primary goal of a late-stage U.S. trial, the Australian company announced on Wednesday. The study tested Mesoblast’s off-the-shelf stem cell product, remestemcel-L, in 55 children who did not respond to steroids after a bone marrow transplant triggered acute Graft Versus Host Disease (aGVHD)…”
“A federal judge in Delaware has overturned a jury’s verdict requiring Gilead Sciences Inc to pay a record $2.54 billion because its hepatitis C drugs Sovaldi and Harvoni infringed a patent held by rival Merck & Co Inc. The verdict had been the largest ever in a U.S. patent case but U.S. District Judge Leonard Stark in Wilmington, Delaware, on Friday ruled Merck’s patent was invalid. He said it did not meet a requirement that it disclose how to make the treatment it covered without undue experimentation…”
“AstraZeneca Plc said on Wednesday an advisory committee of the U.S. Centers for Disease Control and Prevention recommended the use of its FluMist Quadrivalent vaccine in the upcoming flu season, reversing its earlier position…”
“In mice, a single vaccine prompts the immune system to fight breast, lung and skin cancers,” The Los Angeles Times
“In the field of regenerative medicine, induced pluripotent stem cells have a lot of neat tricks up their sleeves. One of them may be teaching the immune system how to beat back cancer. In research that could open a new frontier in the young field of cancer immunotherapy, Stanford University scientists have found that inoculating mice with stem cells that have been inactivated by radiation significantly boosted the animals’ defenses against cancers of the breast, lungs and skin…”