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On the cutting edge
Qlucore, a global player in the development of bioinformatics software, recently announced a license contract with Cambridge Protein Arrays Ltd., a biotech founded in 2010 by Dr. Michael Taussig, located in Cambridge, U.K. Its academic roots are in the areas of protein arraying and specific protein binding antibody reagents. In 2013, it became the European distributor and service provider for HuProt arrays, the largest human protein arrays available, with more than 20,000 human proteins immobilized on a single slide.
With 75 percent of the human proteome represented, HuProt arrays allow the parallel screening of samples of interest for protein interactions, with applications including screening of antibody specificity, protein-ligand interactions and autoimmune profiling.
Autoimmune screening projects in particular involve a substantial number of patients and control subjects, Qlucore notes; for example, screening the serum of each individual in a study on a HuProt array yields a set of more than 20,000 datapoints. In studies encompassing dozens or more subjects, data analysis can be a major bottleneck. By using Qlucore Omics Explorer, the company says, this task is now made considerably easier, offering data exploration and statistical analysis that is supported by instant visualization, making it possible to explore and analyze multivariate data sets interactively.
A new set of bioreactor options
In other recent tools and technology news, Germany-based Sartorius Stedim Biotech, an international supplier for the biopharmaceutical industry, announced the launch of its next-generation BIOSTAT STR, a fully scalable, single-use bioreactor family based on a conventional stirred-tank design. This new bioreactor range featuring upgraded hardware and software, as well as a fully integrated, new design of Flexsafe STR single-use bags, reportedly ensures quick and easy bioprocess scale-up of biologics and vaccines.
The BIOSTAT STR bioreactors are equipped with an improved stainless steel bag holder for user-friendly installation of the single-use Flexsafe STR bag. The bioreactor series, consisting of five systems in different sizes, offers working volumes from 12.5 liters to 2,000 liters.
The company says that the BIOSTAT STR bioreactors are ideal for achieving very high cell densities in continuous processes and for safe manufacture of vaccines and recombinant proteins in cGMP environments. The new bioreactor range provides greater flexibility in bioprocess control and data acquisition as software connectivity has been upgraded to allow integrated control by either BioPAT MFCS software or commonly used third-party industrial distributed control systems, such as Emerson DeltaV or Siemens SIMATIC PCS7.
“Direct linear scalability is crucial for ensuring the efficiency and cost effectiveness of bioprocess development campaigns,” said Dr. Thorsten Adams, director of product management for fermentation technologies at Sartorius Stedim Biotech. “Compared with conventional stainless steel vessels, our next-generation BIOSTAT STR bioreactors in combination with the ambr 250 technology will help reduce process development timelines significantly. These highly scalable, single-use bioreactors are an intelligent, low-risk bioprocess development solution for use in multi-product facilities, as well as at contract manufacturing organizations, for the production of biologics and vaccines.”
New tools for CRISPR
AMSBIO has introduced new CRISPR/Cas9 editing kits for gene knock-out, gene knock-in and gene mutation applications. AMSBIO CRISPR Complete kits are tailor-made for specific projects by AMSBIO genetic engineers, who have extensive experience editing cells and in animal models. CRISPR kits are available for almost any project type, including knockouts, knock-ins, point mutations, gene replacements, humanizations, tagging and more.
AMSBIO also offers a comprehensive selection of CRISPR/Cas9 products for genome engineering—including Cas9 and gRNA delivery systems in a flexible range of formats, homologous recombination donor vectors, and AAVS1 Safe Harbor targeting. This includes all in one Cas9/gRNA vectors, vectors for multiplex gRNA delivery, Cas9 mRNA and protein for transfection and quantitative PCR primers and antibodies for Cas9 detection.
PSC Biotech add a trio of large health players
California-based PSC Biotech Corp. and PSC Software, a wholly owned division of PSC Biotech, say that their cloud-based enterprise quality management software—Adaptive Compliance Engine, or ACE—is now used by three of the four largest healthcare companies in the world. ACE is a 21 CFR Part 11-compliant, EU Annex 11-compliant, integrated software-as-a-service document management and enterprise quality management solution.
“ACE represents a significant competitive advantage for regulated businesses that are facing ever-increasing regulatory pressure to produce high-quality, lifesaving medicine and medical devices, while simultaneously facing price pressures to maintain drug prices at current levels,” said John Clapham, CEO of PSC Biotech and PSC Software.