This week’s headlines include: Russian invasion of Ukraine could affect more than 200 clinical trials across biotech and pharma, Sanofi, GSK to seek authorization for COVID-19 vaccine, Takeda Teams Up with Code in $2B Rare Disease Pact, U.S. FDA chief says he will prioritize fighting misinformation, Discovery of ALS and dementia mechanism points to new treatment strategy, and Moderna to develop mRNA-based shingles vaccine.
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In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Cell transfection is a powerful investigative tool used by many scientists to study gene expression and function across a wide range of applications from cell biology, cancer research, bioproduction of proteins and viruses to developing novel gene therapies to treat diseases. Transfection involves introducing foreign nucleic acids (DNA and RNA) or even proteins into eukaryotic cells. Whether you are new to transfection or it is part of your everyday lab routine, ensuring you have the highest transfection efficiency is critical to experimental success. Defined as the percentage of cells transfected over the total cells, optimizing transfection efficiency can be a tricky endeavor as it is prone to many variable factors, such as cell type, health status, size and type of genetic payload, delivery method–it can be difficult to know where to start to improve your transfection…
3D bioprinting is a powerful tool with the potential to fast-forward translational research for tissue engineering and regenerative medicine. The concept is simple – depositing cells layer by layer following a prescribed 3D pattern to create tissue-like structures that emulate in vivo environments – but complicated to execute. The long-term goal is to use 3D bioprinting to fabricate viable human tissues and organs for transplantation to alleviate the need for living or deceased human donation. Using a patient’s own cells to bioprint an organ could circumvent immune rejection and translate to better clinical outcomes. While the technology is not there yet, 3D bioprinting could be used to create complex biomimetic tissue models to test novel drug therapies, develop patient-specific treatment regimens, and study complex physiological processes. Moreover, 3D bioprinting can be used to generate large-scale constructs using cellular aggregates like spheroids or organoids as building blocks. The specific 3D arrangement of cells within these models reproduces structural features seen in vivo. The spatial distribution of cells, the cell-cell and cell-matrix interactions provide greater predictive power than 2D monolayer cultures and animal models. Although current 3D models, like tissue-specific organoids, have provided insight into developmental and disease mechanisms, the inability to control the organization of the cells within the structures presents a number of limitations that may be solved by 3D bioprinting. Over the past decade, remarkable advancements in bioprinting technologies (i.e., 3D bioprinters and bioink composition) have enabled the biofabrication of realistic 3D biological structures with improved architectural quality and functionality. However, there are still technological challenges to overcome as the field continues to mature and diversify to address more complex questions…
Chromatography columns are an integral part of many biologic purification processes. As such there has been an increase in the use of large-scale columns, including popular stainless-steel Dynamic Axial Compression (DAC) columns. These columns are flexible as they allow packing of any required bed height to enable a variety of different media types and sizes. In addition, their design allows for a quick, easy and homogenous packed bed as well as an even distribution for plug flow of liquid to achieve better peak resolution…
The biopharma industry has continued to embrace automation as a key part of creating more efficient, cost-effective manufacturing. There are many options for how to automate systems, but a universal requirement is the need for a responsive, built for purpose automation software. In most cases automation software provides a single interface for all applications, while this may seem convenient, it often can’t be configured to meet an end users’ exact process or mode of operation…
In this podcast, we talked with Phil Sanders, Biotech Chief Innovation Officer, Agilitech, about the increase in demand for single-use equipment and consumables and how this has led to supply chain shortages. We also talk about how to address these issues by incorporating strategies like being brand agnostic and designing systems that are future proof…
The regulatory approval of several oligonucleotides over the past five years – combined with the recent headlines around rapid COVID-19 vaccine development – has created significant interest in the oligonucleotide (DNA/RNA) segment of the scientific industry. This includes everything from antisense oligonucleotides (ASOs) to lengthy gene transcript mRNA, as well as shRNA (small hairpin RNA), siRNA (small interfering RNA), CRISPR/Cas9 and anti-miR (anti-micro RNA)…
Russia’s invasion of Ukraine is likely to impact millions of people, not just in the Eastern European nation but around the world as drug developers might face delays in clinical trials conducted in Kyiv and elsewhere. One biotech, in particular, called out the geopolitical tensions as possible cause for concern. Karuna Therapeutics warned today that timelines for its second phase 3 study in schizophrenia, dubbed EMERGENT-3, are uncertain because 10 of the 19 trial sites are in Ukraine…
Drugmakers Sanofi and GlaxoSmithKline said Wednesday they will seek regulatory approval for a new COVID-19 vaccine after human trials showed it provided a high level of protection against the disease. Late-stage trials found that two doses of the vaccine were about 58% effective in preventing infection and 75% effective in preventing moderate to severe disease, the companies said in a statement. A separate study on the vaccine’s use as a booster showed that it “induced a significant increase in neutralizing antibodies,” they said…
Takeda and Code Biotherapeutics announced a collaboration agreement to leverage the latter’s proprietary targeted 3DNA® non-viral genetic medicine delivery platform for the design and development of gene therapies for rare diseases. The companies will design and develop targeted gene therapies for a liver-directed rare disease program and conduct additional studies for central nervous system-directed rare disease programs…
Misinformation about science is increasingly prevalent and a significant public health threat that the U.S. Food and Drug Administration will focus on fighting, incoming Commissioner Robert Califf said on Thursday…
Almost all cases of amyotrophic lateral sclerosis (ALS) and half of frontotemporal dementia (FTD) cases are linked to dysfunction in the protein TDP-43. New research from two separate teams have now linked the problem with one of the strongest genetic risk factors for the diseases, revealing a possible biomarker and new therapeutic target. The lack of TDP-43 could sabotage the proper expression of an important neuronal protein called UNC13A. Things could get worse when UNC13A genetic variants were present, increasing the risk to more severe ALS and FTD. Two research teams, one led by Stanford University and Mayo Clinic and the other by University College London (UCL) and the National Institutes of Health (NIH), described those same discoveries in studies published in Nature…
Moderna Inc (MRNA.O) said on Friday it is developing three new vaccines based on the same technology used for its COVID-19 shot, including one for viral infection shingles. The success of COVID-19 vaccines based on messenger RNA (mRNA) technology from Moderna and rival Pfizer (PFE.N) has prompted efforts to use the novel technology in other vaccines and therapeutics targeted at hard-to-treat diseases…
