Friday, June 18, 2021 Daily Archives

A Complete Solution for MSC Therapy Workflows: Cell Scale-Up, Cryopreservation, and DMSO Removal

Mesenchymal stem cells (MSCs) are used frequently for cell therapy applications. As multipotent cells, they can differentiate into other lineages such as adipocytes, osteocytes, and chondrocytes. Additionally, they are known to secrete trophic factors that can play important roles in immunoregulation. Although MSCs can be isolated from several different tissue sources, those derived from bone marrow commonly are studied because they are easy to access in quantities large enough for therapeutic dosing (2 × 106 cells/kg of body weight). Still,…

Validation of a Next-Generation Single-Use Turbidity System

Turbidity describes the relative clarity of a liquid as the result of suspended solids. Instruments that measure turbidity typically use a beam of light to detect particles by measuring the difference between the amount of light emitted from the light source and the amount that is received by a detector. Such measurements are affected by the size, shape, and number of particles in a sample of liquid because those solids scatter the incoming light, which provides an apparent absorbance that…

Overcoming Obstacles in AAV Viral Vector Manufacturing

Rapidly growing interest in gene therapy has led to the need for more cost-effective and scalable viral-vector manufacturing platforms. Adenoassociated virus (AAV) has become a vector of choice because of its safety profile (nonpathogenic infection). In addition, AAV cannot replicate on its own and is not integrated directly into the host genome. AAV vector manufacturing using human embryonic kidney (HEK) cells in either adherent or suspension mode includes several typical processing steps: cell expansion, plasmid transfection, viral-vector production, cell lysis,…

Eliminating the Analytical Bottleneck in Production and Purification of mRNA

COVID-19 has focused a spotlight on the ability of mRNA technology to accelerate vaccine development and approval (1). That same technology can hasten development and approval of other therapeutic classes, including cancer immunotherapy, protein replacement, and gene therapy. Fulfilling those opportunities imposes significant challenges on process developers and manufacturers to improve existing processes. Scale-up to produce millions of doses (tens of kilograms) compounds those challenges. Furthermore, every step of the journey requires high-performance analytical methods, to ensure patient safety and…

Space Travel Rockets Mitochondria’s Central Role into the Spotlight

Mitochondria originated millions of years ago, likely when a eukaryotic cell incorporated a bacterium. Thus, mitochondrial DNA strands are 200,000× smaller than those from a cell’s nucleus. Depending on cell type, thousands of mitochondria can reside within the walls of one human cell. The scientific community long has considered these organelles to be cellular “energy factories.†But their centrality to human health and disease only now has come to light. In a breakthrough study published in Cell (1), biologists collaborated…

Enzymatic DNA printer will speed R&D and COVID testing, says DNA Script

DNA Script has launched a benchtop nucleic acid printer it claims will accelerate molecular biology, genomic research, and even COVID-19 testing. The Paris, France firm unveiled Syntax this month, describing it as a fully integrated, automated printer that is able to synthesize 96 DNA oligonucleotides in parallel, comprised of up to 60 nucleotides in length. The technology uses enzymes to synthesize the DNA molecules which – unlike traditional phosphoramidite chemistry based approaches – accelerates and optimizes production and eliminates the…

Danaher entering pureplay CDMO space in $9.6bn Aldevron buy

Danaher Corporation will add protein production, plasmid DNA, and mRNA services to its bulging life sciences portfolio through the acquisition of Aldevron. The deal will see Danaher Corporation buy North Dakota-headquartered contract development and manufacturing organization (CDMO) Aldevron from private equity firm EQT for $9.6 billion. The business will operate as a standalone within Danaher’s Life Sciences segment, which includes such businesses as bioprocessing firms Pall Corporation and Cytiva, bought for $13.8 billion and $21 billion, respectively. Through the acquisition,…