This week’s headlines include: AstraZeneca sees pivotal lung cancer trial results later in 2018, Opposite Day: Drug May Save Lives, So Drugmakers Offer To Cut Price, What’s Behind Many Mystery Ailments? Genetic Mutations, Study Finds, Targeting a brain protein to preserve memory, House Rejects Bill to Give Patients a ‘Right to Try’ Experimental Drugs, and 2 measles cases put U.S. travelers on high alert.
In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
BPI West 2018 begins March 20th in San Francisco. The conference is focused on providing companies the opportunity to share ideas, strategies, and solutions to overcome challenges at every stage of development. Cell Culture Dish/Downstream Column will be attending and blogging from the event. Please don’t miss our BPI West related blogs over the next month…
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…
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 . 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 …
Ask the Expert – Incorporating recombinant proteins to produce blood-free media formulations for therapeutic cell types
Inclusion of human plasma or plasma-derived proteins, such as albumin and transferrin, in cell culture systems produce media with acceptable performance at small scale. However, scale up to clinical manufacturing with these components proves to be more difficult. Most often plasma or plasma-derived components need to be screened prior inclusion in manufacturing processes as these raw materials often induce unacceptable variability in the final cell product. These variabilities often manifest in unexpected cell or cell product yield or unwanted drifts in the expected phenotype or function of cell or cell-based products. Further, the inclusion of human plasma or plasma-derived components introduces the risk of contamination from adventitious agents…
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…
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…
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…
BPI West 2018 begins March 20th in San Francisco. The conference is focused on providing companies the opportunity to share ideas, strategies and solutions to overcome challenges at every stage of development. Cell Culture Dish/Downstream Column will be attending and blogging from the event. Please don’t miss our BPI West related blogs over the next month.
Check out our blog on great talks and activities at the conference – “Next Week BPI West in San Francisco – Don’t miss Exciting Talks and Activities!“
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
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.
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:
“AstraZeneca now expects a key lung cancer study of two immunotherapy drugs to produce overall survival results in the second half of 2018, rather than the first half…”
“Praluent, a would-be breakthrough that targeted a heart attack gene, seemed doomed to go down in history as a pharmaceutical flop. But a new study — and an offer of discounts by its makers — may give it a second chance…”
“Gregor Mendel discovered fundamental rules of genetics by raising pea plants. He realized that hidden factors — we now know them to be genes — were passed down from parents to offspring. It wasn’t until the early 1900s, long after Mendel’s death, that doctors discovered that humans weren’t so very different. Some diseases, it turns out, are inherited — they’re Mendelian…”
“When people age, certain circuits in the brain’s hippocampus—the region that generates and stores memories—become hyperactive. That may be why memories become jumbled, many scientists believe. And it’s not just age that causes those circuits to malfunction. People with post-traumatic stress disorder (PTSD) also lose the ability to remember specific details over time…”
“In a surprising rebuff to President Trump and Republican leaders, the House derailed a bill on Tuesday that would have given patients with terminal illnesses a right to try unproven experimental treatments. The bill was considered under special fast-track procedures that required a two-thirds majority for passage, and it fell short. When the roll was called, 259 House members supported the bill, and 140 opposed it…”
“Health officials are warning people who went through airports in Newark, New Jersey, Detroit and Memphis this month that they may have been exposed to measles. The disease was carried by two air passengers from overseas. The two cases happened within days of each other. The first was on March 6, when a contagious passenger flew from an unknown origin abroad to Detroit Metropolitan Airport and was later hospitalized. The second involved a young child from Brussels who flew into Newark Liberty International Airport, then went to Memphis, where the child was isolated…”