Spotlight Biotechnology/Immunology


A Promising Partnership for Biomarker Discovery Scientists at CLIPP (Clinical Innovation Proteomic Platform) use two of Tecan’s Freedom EVO®


Immunoassay Milestone platforms


to automate sample preparation for a biomarker discovery project based at the Hospital and Cancer Center in Dijon, France.


Dr Patrick Ducoroy leads CLIPP, and explained the role of automation in the project: “High sample numbers and throughput are of paramount importance to us in order to identify good, robust biomarkers for investigation. It is also vitally important to standardise procedures and treatment of samples and, in the early discovery phase, stringent quality control is a must. Quite simply, automation is essential to achieve all these objectives.


“Our workstations are fully integrated with one another, maximising automation and standardisation of the sample preparation. A Freedom EVO 200 aliquots samples into 96-well microplates, then transfers these plates to a Freedom EVO 100 for protein and peptide purification, allowing us to process 96 patient samples for mass spectrometry in just one hour. Ultimately we are aiming for a thousand samples a week, and Tecan’s technology will be central to us achieving this goal. We have had very good support from


Tecan, particularly in modifying the parameters of the workstations. I am sure this has helped us to achieve such excellent reproducibility of results, with the high throughput that we need.”


Circle no. 547 Setting Gold Standards Novozymes Biopharma announced that its Recombumin® and albucult®


products are the first to comply with the new excipient monograph standard for recombinant human albumin, published in the United States Pharmacopoeia – National Formulary (USP-NF). The monograph was first published in November 2008 and became official on 1st May 2009. As these products comply with the monograph, their use eases the regulatory process for customers and sets the industry benchmark for recombinant human albumin.


Recombumin® offers the stabilising and formulation benefits of human derived


albumin in a GMP compliant and regulatory friendly package. Derived from Novozymes’ proprietary yeast expression technology, it is the world's leading animal-free, commercially available recombinant human albumin for use in the manufacture of licensed and developmental human therapeutics in the US and European markets. Albucult®


is also a yeast-derived recombinant albumin, targeted


for use in specialised cell culture and as a bulk drug manufacturing raw material, such as in peptide or small molecule drug chemical coupling for delivery or half-life extension.


Wayne Prestwood, Principal Regulatory Associate at Novozymes Biopharma, commented: “We are delighted to be setting the gold standard with our Recombumin and albucult products by being the first to comply with the new monograph. This is of significant benefit to our customers, providing peace of mind whilst facilitating regulatory agency review and approval.”


The monograph refers to recombinant human albumin as ‘rAlbumin Human NF’ listed as a ‘sterile vehicle’, meaning that it is intended for injection into humans alongside the active ingredient, and as such needs to be of the highest safety and quality.


Circle no. 548


Siemens Healthcare Diagnostics recently celebrated the production of its 2000th ADVIA®


system at the Swords manufacturing site in Dublin, Ireland.


ADVIA Centaur XP is designed to improve productivity in immunodiagnostic testing. It combines intelligence and technology, offering high throughput testing with up to 240 tests per hour to keep pace with peak workload times. It also features an intuitive design with a high-resolution touch screen for ease of operation. Its comprehensive menu covers screening, diagnosis, risk assessment and monitoring with 30 onboard reagents for maximum test capacity.


“The success of ADVIA Centaur XP is testament to its flexibility and efficiency,” said Alison Edgington, Immunoassay Marketing Manager at Siemens Healthcare Diagnostics. “Throughout the UK, laboratories are successfully running the system on or off our high throughput ADVIA®


automation systems to deliver


predictable sample turnaround times in routine and specialised testing. Our ongoing investment in both instrument design and continued assay releases places the ADVIA Centaur XP firmly in the minds of laboratories meeting the workload challenges of UK pathology in the 21st century.”


Launched in 2006, the Centaur XP continues to build on the success of its predecessor, the ADVIA®


Centaur. Today there are more than 5000 Centaur XPs and Centaurs installed. Circle no. 549 Centaur XP immunoassay


Kidney Transplantation Immune Response and Tolerance Studies


Invitrogen has announced the global availability of a new biomarker tool for use in pre- clinical research into kidney function. The PlexMark™ 3 Renal Biomarker Panel Assay is a non- invasive and cost-effective research tool for performing post-transplantation kidney function studies rapidly and easily. The introduction of this research tool is expected to help in the development of studies that may lead to more effective methods for monitoring kidney health in transplant research.


This new assay provides researchers with an alternative to invasive and expensive procedures, such as biopsies, used to obtain kidney tissue samples to allow research into post- transplantation kidney function. The PlexMark 3 Renal Biomarker Panel Assay measures levels of cytokines, chemokines and receptor levels in urine, which give researchers a better understanding of immune function and response. This may lead to the development of new, non-invasive tests to monitor kidney function and health following transplant procedures.


The PlexMark assay uses Luminex® xMAP® multiplexing technology for bioassay analysis, in a


standard immunoassay format to offer ease-of-use, sensitivity and rapid, reproducible results. The biomarkers in the PlexMark panel are licensed from Renovar Inc, a pioneer in the development of new tools for assessing kidney inflammation for numerous clinical indications.


Dr Brian D Shames, Assistant Professor of Surgery, Division of Transplant Surgery at the Medical College of Wisconsin, said: “Development of a non-invasive test that could help differentiate between acute renal injury, rejection and infection would satisfy a critical unmet need in transplantation. A biomarker test that can accomplish this would be of extreme importance in pre-clinical kidney transplantation research.”


Circle no. 550


Essential Primates for New Therapeutics


PBL InterferonSource introduced the new high-sensitivity VeriKine™ Cynomolgus/Rhesus Interferon-Alpha Serum ELISA kit for determining macaque IFN-Alpha levels. This assay will enable interferon quantification in Cynomolgus and Rhesus Macaque model systems for viral disease, autoimmune disorders and immunotoxicology. In the past, these models have been used to determine the pathology of deadly human viruses including Ebola, SARS and the 1918 pandemic influenza virus.


VeriKine™ Cynomolgus/Rhesus IFN-Alpha Serum ELISA kit has superb matrix compatibility. It is sensitive to 25pg/ml and can detect the protein in a wide variety of sample matrices and test concentrations with an accuracy of +/-20% the expected values in small or large sample sets. The kit performs just as well in Rhesus and Cynomolgus serum and plasma samples.


The kit also detects the bioactive form of the Rhesus/Cynomolgus IFN-Alpha 2 protein suggesting that research can be expedited by minimising the number of samples to be analysed in bioassays.


IFN-Alpha can be both protective, as a critical player in host immune responses, and harmful, as a major factor in autoimmune disorders such as Systemic Lupus Erythematosus. The development of this kit to determine the levels of IFN-Alpha in non-human primates should allow for an increased understanding of this duality.


VeriKine™ Cynomolgus/Rhesus Interferon-Alpha Serum ELISA kit is just one of the high- performance products being developed every day at PBL InterferonSource for the life sciences community.


Circle no. 551


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