Agilent Technologies says they plan to invest $20 million to expand their Shanghai manufacturing centre to meet growing demand in China for the company’s advanced liquid chromatography (LC), spectrometer and mass spectroscopy (MS) systems.
BioGenes and Alphalyse have been active in the field of Host Cell Protein (HCP) detection for many years and have now partnered up to offer their respective methods to biologics developers for optimal outcomes.
Berlin-based BioGenes focusses on challenging and customized antibody and immunoassay development projects, with a particular focus on HCP ELISAs and related 2D gel analytics, for quality control, diagnostics, and the development and testing of new biological therapeutics. Alphalyse is a specialist contract research organization with expertise in HCP coverage analysis by Liquid Chromatography (LC) – Mass Spectrometry (MS) to support biopharmaceutical companies in their process development and manufacturing of patient-safe products, such as mAbs, vaccines, recombinant proteins, and cell and gene therapies.
HCPs stem from the production cell line used for biological product manufacturing. Defined as process-related drug impurities, they can negatively influence a biological drug’s quality, safety, and efficacy. Naturally, the accurate detection of HCP impurities heavily depends on the establishment of reliable and robust methods for HCP measurement.
The HCP ELISA is the predominant assay for continuous HCP monitoring, and ELISA reagent characterization is vital for determining the assay’s suitability for HCP detection and quantification. The most important parameters are a sufficient total HCP coverage, the demonstration of HCP log reduction, and a high level of assay accuracy. As recommended by current guidelines, the coverage determination should be performed using orthogonal methods.
Biologics developers have an increasing need for simultaneous HCP measurement and identification to improve HCP risk assessment: the ELISA is used for antibody-dependent measurement, and LC-MS for HCP identification. BioGenes and Alphalyse will provide their combined know-how and experience in the HCP field to support the combined use of their respective methods. The combination of BioGenes’ more than 20 years in HCP ELISA development and Alphalyse’s experience in LC-MS for HCP monitoring combined with the orthogonal methods IAC-2D DIGE and ELISA-MS for reagent characterization will enable a solid HCP surveillance strategy including quantification and identification of relevant HCPs.
For biologics developers, this means maximized certainty regarding HCP levels and improved HCP documentation for approval by regulatory entities.
“We are very pleased to be working with Alphalyse, and believe that we can achieve great results from a combined strategy,” said Dr. Alexander Knoll, CEO of BioGenes. ”Together, we can make it possible for customers to rely on orthogonal methods for their drug development and increase their chances for successful market authorization. At the same time, we will be able to improve drug efficacy, and thus patient safety.”
Thomas Kofoed, CEO of Alphalyse, added: “Both companies have been very successful with their respective approaches for years. In this respect, they complement each other very well. It is exciting to see how the combination of both our methods will hopefully change the future of HCP monitoring and become the new standard in drug development processes.”
https://clinlabint.com/wp-content/uploads/sites/2/2022/02/biogenes.jpg851567panglobalhttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.pngpanglobal2022-02-24 10:20:022022-02-24 10:20:02BioGenes and Alphalyse collaborate to optimize ELISA reagent characterization for biomanufacturing
ProBioGen has agreed a multi-product commercial license with AstraZeneca to use the GlymaxX technology.
Following evaluation of the technology under a research license, AstraZeneca will now continue to use GlymaxX and will integrate the technology into their drug discovery.
GlymaxX improves target cell killing orchestrated by natural killer cells, thereby enhances antibody-dependent cell-mediated cytotoxicity (ADCC). It is a universal, simple technology that allows modifying existing cell lines or creating new ones, demonstrating its flexibility. Another unique advantage of GlymaxX is that it allows using the same modified cell line to produce antibodies of varying levels of fucosylation.
Dr Gabriele Schneider, ProBioGen’s Chief Business Officer, said: “We are delighted that AstraZeneca decided to implement our technology, which has shown great potential in making molecules more potent and efficient.”
The GlymaxX technology, developed by ProBioGen, prevents the addition of the sugar “fucose” to the N-linked antibody carbohydrate part by antibody producing cells. The absence of fucose enhances ADCC (antibody-dependent cell-mediated cytotoxicity) activity for antibodies directed against cancer and infectious diseases. The GlymaxX technology is based on the stable introduction of a gene for an enzyme which deflects the cellular pathway of fucose biosynthesis. ProBioGen offers this technology royalty-free to third parties. The technology has been widely applied worldwide in the biotech and pharma industry to produce afucosylated molecules.
https://clinlabint.com/wp-content/uploads/sites/2/2022/02/glymaxx.png354524panglobalhttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.pngpanglobal2022-02-24 10:00:172022-02-24 10:00:17AstraZeneca to use ProBioGen’s GlymaxX technology for drug discovery
Leading researchers are warning of the dangers of a quiet epidemic of vitamin B12 deficiency in people who follow increasingly popular plant-based diets and explain how it can be addressed.
https://clinlabint.com/wp-content/uploads/sites/2/2022/01/vegan_food-scaled.jpg17092560panglobalhttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.pngpanglobal2022-01-18 13:23:212022-01-20 12:37:28Researchers sound warning on vitamin B12 deficiency for people following plant-based diets
Microplastics – tiny pieces of plastic less than 5 mm in length – are everywhere, from bottled water to food to air. They have been found in the deepest part of the ocean and the top of Mount Everest. According to recent estimates, people consume tens of thousands of these particles each year, with unknown […]
https://clinlabint.com/wp-content/uploads/sites/2/2022/01/microsplastics.png12242514panglobalhttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.pngpanglobal2022-01-18 13:20:532022-01-20 12:36:55People with IBD have more microplastics in their faeces, study finds
A common strategy to make vaccines more powerful is to deliver them along with an adjuvant – a compound that stimulates the immune system to produce a stronger response.
https://clinlabint.com/wp-content/uploads/sites/2/2022/01/vaccine-scaled.jpg25602560panglobalhttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.pngpanglobal2022-01-18 13:17:502022-01-18 13:17:50Immune system-stimulating nanoparticle could lead to more powerful vaccines
To solve the mysteries of how learning and memory occur, Johns Hopkins Medicine scientists have created a system to track millions of connections among brain cells in mice – all at the same time – when the animals’ whiskers are tweaked, an indicator for learning.
https://clinlabint.com/wp-content/uploads/sites/2/2022/01/3d-brain-synapses-scaled.jpg13992560panglobalhttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.pngpanglobal2022-01-18 13:14:582022-01-20 12:36:03Researchers create mind-blowing tool to visualise millions of neuronal synapses in mouse brain
PhoreMost, a UK-based biopharmaceutical company dedicated to developing drugs against intractable disease targets, and Polaris Quantum Biotech, a North Carolina-based quantum computing drug design company, will collaborate to study oncology targets currently considered undruggable.
https://clinlabint.com/wp-content/uploads/sites/2/2022/01/phoremost_quantum-scaled.jpg17072560panglobalhttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.pngpanglobal2022-01-18 12:41:532022-01-20 12:35:27PhoreMost, POLARISqb to investigate next-gen cancer therapies with quantum computer
Metrion Biosciences, a specialist ion channel contract research and drug discovery company, and Bioqube Ventures, a specialist European life sciences investment firm, have entered into a collaboration, backed by Bioqube Factory Fund I, to incubate a drug discovery research project targeting autoimmune diseases.
MolGen B.V., a provider of DNA / RNA extraction technology, has opened an office in London, UK. The new location will serve as a pivotal branch to provide laboratories in the UK with access to the company’s extraction DNA / RNA portfolio across diagnostics, pharma and the biotech industry. The opening of the London office […]
https://clinlabint.com/wp-content/uploads/sites/2/2022/01/MolGen-scaled.jpg17072560panglobalhttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.pngpanglobal2022-01-18 12:38:292022-01-18 12:38:29MolGen opens new offices in UK, US
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