This week’s headlines include: AIDS Researcher Top Candidate to Lead the C.D.C., Anti-flu drug exploits weakness in H3N2 strain, China’s Aim to Remove Cancer Drug Taxes May Boost Pfizer, Glaxo, Novartis touts U.S. filing plans for MS drug as patent losses loom, House to Revive ‘Right-to-Try’ Bill Next Week, Passage Expected, and Only 3 in 10 children asked to draw a scientist drew a woman. But that’s more than ever.

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

Cell Therapy Manufacturing – Opportunities and Challenges

In this podcast and accompanying we interviewed Dr. Robert Preti about the past, present and future of global Cell Therapy manufacturing. We also discussed major industry milestones, manufacturing challenges and opportunities for the further improvements…

Use of Recombinant Proteins to Create a Blood-free Media Formulation – A Discussion

We recently finished our Ask the Expert discussion, “Incorporating recombinant proteins to produce blood-free media formulations for therapeutic cell types”. During this Ask the Expert session, we discussed transitioning cells to blood free formulations, cell health and growth in blood-free medium and associated benefits…

Video Series – Maintaining Bioprocess Validation

Bioprocess validation is not only a regulatory requirement, it is also a key component in ensuring the quality and efficiency of a biomanufacturing platform. This week’s Two Minute Tuesday educational video is the first in a four part series of interviews with Dr. Shawn Latham, Validation Manager at Shire Plc. In this video Shawn is interviewed on maintaining validation in biomanufacturing. He discusses how during filing for licensure you must prove that your process claims are true and then you must maintain that those claims are true over time. As time passes, equipment and processes may drift and so based on risk based assessments, validation measures must be established. High risk areas must be validated more frequently…

CELLvo™ Human Cord Blood-Endothelial Progenitor Cells are Highly Proliferative and Angiogenic

Endothelial cells from the umbilical vein (hUVECs), artery (hAECs), and microvasculature (hMVECs) have been important in elucidating the pathways involved in angiogenesis and may have important clinical applications in the treatment of ischemic tissues or in the vascularization of graft tissues. In 2004, Mervin Yoder first described a novel population of rare circulating putative endothelial progenitor cells (EPCs) found in human umbilical cord blood and, less abundantly, in human adult peripheral blood [1]. These cells were highly proliferative relative to more commonly utilized endothelial-type cells. Yoder dubbed these putative endothelial progenitor cells as endothelial colony forming cells for their astounding capacity to form large primary, secondary, and tertiary colonies, as compared to other endothelial cell types. In addition to having superior colony forming ability, these cells have been shown to possess greater angiogenic potential in vitro as well as in vivo and it has been suggested that they may actually be progenitors of other endothelial cell types [2]…

Global Downstream Bioprocessing Market Expected to Demonstrate Significant Growth

Downstream bioprocessing involves a number of products such as chromatography columns and resins, filters, membrane adsorbers, single-use products, and other products (consumables and instruments). Columns and resins are the most important components of a chromatography system and are extensively used in the separation, recovery, and purification of components of a bioactive sample. In addition, different samples in the drug development phase require different types of columns for separation, and these columns have to be frequently changed to optimize the stationary phase. Also, for the purpose of purification, resins need to be repurchased…

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…

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

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 from iTunes or Google play:

Headlines:

“AIDS Researcher Top Candidate to Lead the C.D.C.,” The New York Times

“One of the nation’s leading AIDS researchers and an expert in the treatment of heroin addiction is the leading candidate to oversee the Centers for Disease Control and Prevention. A formal announcement about the candidate, Dr. Robert R. Redfield, could come as early as Tuesday, once the vetting has been finished, said an administration official with knowledge of the appointment, who was not authorized to speak publicly…”

“More than 65,000 Americans have been victims of influenza A H3N2 this season, according the Centers for Disease Control. And this particular strain of the flu virus has proven to be remarkably resistant to vaccination, because it frequently mutates after the vaccine has been formulated. Could antiviral treatments help tamp down the virus after infection?”

“China’s Aim to Remove Cancer Drug Taxes May Boost Pfizer, Glaxo,” Bloomberg

“China Premier Li Keqiang’s aim to eliminate import taxes on cancer drugs and significantly lower those for other medicines may provide a boon for global drug makers looking to the world’s second-biggest pharmaceutical market for growth…”

“Novartis touts U.S. filing plans for MS drug as patent losses loom,” Reuters

“Novartis plans to file its BAF312 multiple sclerosis drug for U.S. approval within weeks, the Swiss drugmaker said on Friday, as it seeks to refresh its portfolio of neurological medicines that is about to be hit by patent losses…”

“House to Revive ‘Right-to-Try’ Bill Next Week, Passage Expected,” Regulatory Focus

“The US House of Representatives’ Rules committee on Monday will take up the same “Right-to-try” bill that failed earlier this week. The bill is expected to easily move through the House, as it will only need a simple majority to pass…

“Only 3 in 10 children asked to draw a scientist drew a woman. But that’s more than ever.” The Washington Post

“In 1983, a social scientist named David Chambers published a landmark study on children’s drawings. During the late 1960s and the 1970s, teachers asked nearly 5,000 children to draw a scientist. Features of those doodles included lab coats, eureka exclamations and, Chambers noted, “abnormally long sideburns.” A singular theme emerged: The scientists were men…”