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On the cutting edge
March 2019
by Jeffrey Bouley  |  Email the author
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HERCULES, Calif.—Leading off the latest roundup of the tools of the pharma and biotech trade (whether hardware, chemical or software) is Bio-Rad Laboratories Inc., which announced in early February the launch of a range of recombinant monoclonal anti-idiotypic antibodies that inhibit the binding of eculizumab (Soliris) to its target, complement C5 protein. These anti-eculizumab antibodies detect free drug and are designed for use in drug level monitoring assays and biosimilar development.
 
The new range of recombinant monoclonal anti-idiotypic antibodies is comprised of four inhibitory antibodies that are highly specific for the humanized IgG2/4 kappa monoclonal antibody drug, eculizumab, a biotherapeutic that is used to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
 
The anti-eculizumab inhibitory antibodies can be used to quantify the level of eculizumab in patient samples, and they may also be used in bioanalytical assays for biosimilar development. An antibody pair is suitable for the development of a pharmacokinetic (PK) bridging ELISA, and antibodies of high, medium, and low affinity can be used as a positive control or calibrator in an anti-drug antibody assay.
 
The recombinant monoclonal anti-idiotypic antibodies are generated using the Human Combinatorial Antibody Library (HuCAL) and CysDisplay, a proprietary method of phage display with guided selection methods to obtain highly targeted reagents. The recombinant production method also ensures a consistent and secure supply.
 
“Bio-Rad’s portfolio of highly specific anti-biotherapeutic antibodies continues to expand, providing critical reagents for use in preclinical and clinical development of biosimilars, and for therapeutic drug monitoring of patients,” said Amanda Turner, Bio-Rad’s product manager for the Life Science Group. “Our unique anti-eculizumab antibodies are well characterized and have been validated for use in PK and immunogenicity assays. Adding new specificities to our portfolio will help researchers overcome challenges associated with assay design and sensitivity,” she added.
 
The anti-eculizumab antibodies are approved for in-vitro research and for commercial applications of in-vitro testing services that support preclinical and clinical drug and biosimilar development and patient monitoring.
 
More efficient and easier lab management
SOMERSET, N.J.—Also in early February, LabVantage Solutions, a global provider of laboratory informatics solutions and services, unveiled LabVantage 8.4, the latest version of the company’s comprehensive laboratory information management solution. Encompassing LIMS, ELN, and LES, LabVantage 8.4 incorporates new and updated features that increase lab efficiency and effectiveness while making the work of managers and staff easier. The most significant changes include new features for work planning and managing resource capacity and availability, as well as enhanced capabilities to ensure data privacy.
 
“LabVantage 8.4 includes many valuable new features, but we are most excited by its unprecedented work assignment and resource planning functionality—the most powerful and robust available today,” said John Heiser, CEO of LabVantage Solutions. “We understand that managing resources, workflow and staff is one of our customers’ biggest challenges. Our new Work Assignment and Resource Planning (WAP) module greatly simplifies and facilitates this process, empowering our users to manage their laboratories and workflows more efficiently and effectively with far less time and hassle. With LabVantage 8.4, laboratory directors can finally optimize every aspect of their operations for their individual labs or network of labs.”
 
New and updated features of LabVantage 8.4 include work assignment and resource planning, data privacy, a new master data navigator, bulk data import and automated issue tracking and submission.
 
Software-enabled pipettes
GOETTINGEN, Germany & GENEVA—A pair of companies announced recently the launch of the Andrew Alliance Pipette+ system, which they say “uniquely provides both full traceability and improved repeatability in manual pipetting for life-sciences laboratories.”
 
This product alliance to bring an  “intelligent pipetting solution” to market pulls together Andrew Alliance S.A., a robotics company with an innovative approach to liquid handling that is improving repeatability of conventional laboratory pipettes, and the life-sciences company Sartorius.
 
The partners say that as much as half of all research funding in life sciences is used to repeat experiments, “showing that lack of reproducibility in research is an ongoing challenge in the biopharmaceutical industry. A major cause of irreproducibility has been incorrect execution in liquid handling workflows. This collaboration between Andrew Alliance and Sartorius reflects both companies’ strategic investment in designing innovative pipetting solutions to improve reproducibility and simplify the complex and time-consuming workflows.”
 
The Andrew Alliance Pipette+ system comprises several components that communicate with one another: electronic single and multichannel pipettes, an intelligent stand, and novel cloud-based software. Andrew Alliance co-developed the Pipette+ system with Sartorius, who is manufacturing the pipette hardware. The hardware is based on Sartorius’ Picus range of award-winning, ergonomic electronic pipettes.
 
“We worked together with Andrew Alliance to provide the scientific community with a next-generation solution for manual pipetting. We’ve been at the forefront of the electronic pipette  revolution with our Picus pipette and are now connecting the world of pipetting to the world of computing. This represents a quantitative leap in the performance of electronic pipettes over that of mechanical devices,” says Venkat Rao, head of business management for the EMEA Life Science Research operation at Sartorius.
 
New Zika immunoassays
OXFORD, U.K.-Late 2018 saw The Native Antigen Company launch a series of immunoassays for Zika virus, offering researchers in academia, public health and drug discovery the capability to work with what the company calls “unprecedented levels of specificity and sensitivity.” Unlike previous methods, the new assays reportedly have little or no cross-reactivity with other flaviviruses, including Dengue, West Nile, yellow fever, Japanese encephalitis, tick-borne encephalitis and Usutu virus.
 
The Native Antigen Company Zika Virus NS1 ELISA assay is a highly sensitive and specific assay suitable for the quantitative detection of Zika Virus NS1 in a range of biological samples, with no cross-reactivity with other flaviviruses. Present in human serum during the early stages of infection, the NS1 protein provides an early marker of viral replication following infection. This ELISA assay can detect NS1 antigen at levels as low as 5 pg/ml and enables researchers to measure the level of Zika NS1 protein in infected patients, offering value in epidemiology studies.
 
In an independent assessment of the Zika Virus IgG/IgM/IgA ELISA kit, external researchers reported a sensitivity of 90.3 percent and specificity of 92.1 percent. This compared favourably with direct testing against a market-leading IgG assay that exhibited only 69.4 percent specificity, the company says.
 
“The launch of these next generation assays represents a significant leap forward for Zika virus detection and monitoring, which to date has always been hampered by Zika’s cross-reactivity with dengue,” said Dr. Andy Lane, commercial director at The Native Antigen Company. “The impact of this exciting development will be seen across academia, public health and the pharmaceutical industry.”
 
In addition to the kits, The Native Antigen Company also offers an extensive range of Zika virus antigens, both expressed as recombinant proteins in a mammalian expression system and as native viral preparations. Further products include NS1 proteins (from both the prototypic Uganda strain and from the Suriname strain responsible for the major outbreak in 2016) and Zika virus-like particles.
 
High precision in endotoxin detection
WALKERSVILLE, Md. & BASEL, Switzerland—Lonza recently unveiled PyroTec PRO, said to be the first-ever fully automated, plate-based robotic solution for endotoxin detection. Integrated with the latest version of Lonza’s proprietary dynamic control WinKQCL 6.0 Software platform, the new system has been designed to meet the needs of rapidly changing requirements of quality control testing laboratories for fully automated processing of simple to complex sample matrices.
 
As a powerful combination of robotic liquid-handling technology with an automation software module, the system reportedly:
  • Improves data integrity organically with the capture of new metadata from the automated preparation, adding traceability into tracking, trending and audit controls
  • Can take any new and existing templates and dynamically “script” the instructions to an automation template with relatively minimal effort from the end user, regardless of how complex the sample type or testing requirements
  • Enhances assay robustness and reproducibility for increased confidence in the accuracy and precision of results
  • Significantly reduces manual intervention, simplifying QC testing workflows and eliminating the human error potential
  • Reduces re-test rates, as well as out-of-specification and out-of-trend deviations, thereby improving the laboratory’s performance
  • Integrates with laboratory information management systems or Lonza’s MODA Solution, facilitating fully paperless workflows and traceability of sample lifecycle
  • Offers considerable cost savings compared with conventional cartridge-based systems, which require the use of expensive reagents
  • Aligns with the U.S. Food and Drug Administration’sProcess Analytical Technology Initiative and Data Integrity requirements and is fully compliant with the U.S. Pharmacopeia Bacterial Endotoxin Test guidance
“The introduction of the PyroTec PRO Automated Robotic Solution and WinKQCL 6.0 Software marks a milestone in endotoxin detection, allowing pharmaceutical manufacturers to replace manual, error-prone processes with a fully automated solution,” said Robert Porzio, product manager for endotoxin detection at Lonza.
 
Code: E031929

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