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Adalimumab – blockbuster & never ending story

Resolved patent disputes With Abbvie and Alvotech having solved their patent disputes, market entry for new biosimilars for adalimumab applicable for various indications might speed up. The patent protection of the originator product  Humira ® has expired in the EU in 2017, though due to complex patent claim development and market launch of non-component material
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VelaLabs announces GLP extension

VelaLabs has successfully been granted the extension of its GLP certification.   Klaus Hajszan, Head of Quality and Test Site Manager, about this important step: “We have been GLP certified in 2020 for the first time and since then have continuously improved and strengthened our testing processes to ensure safety and quality”. The team responsible
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How to set up assays for HER2 expressing cancer cells

HER2/neu binding antibody trastuzumab One of the major & established therapies targeting breast cancer is the HER2/neu binding antibody trastuzumab. It has improved the five-year disease free survival of stage 1–3 HER2-positive breast cancers to about 87%. The patent protection of the originator product  Herceptin ® has expired in the EU in 2014 and the
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Turbidity and Colour measurment

Beyond visual inspection – new Turbidity and Colorimetry devices at VelaLabs

As a well known & trusted lab analysis partner for drug development to Pharma and Biotech companies VelaLabs continuously invests in state-of-the-art technology. A new turbidimeter TL 2360 and a new colorimeter Lico 690 have been installed. According to pharmacopoeia Monographs Ph. Eur. Chapter 2.2.1 and USP <855 measurements of clarity and degree of opalescence
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From management buyout to international player

As an analytical partner for biotech and pharma companies, VelaLabs delivers expertise and laboratory analysis services throughout the whole drug development process.   Development VelaLabs  was founded as “Vela pharmazeutische Entwicklung und Laboranalytik GmbH” as a management buy out end of 2006 and took over analytic and infrastructure of the former Novartis spin off Ingeneon.
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VelaLabs im Biotechnologie Jahrbuch N34

Spreading out wings – VelaLabs in Biotechnologie Jahrbuch N34

VelaLabs is one of 151 Biotechnology companies in Austria offering analytical laboratory services from medication development to market release. The company figures reflect the positive trend of the industry in terms of revenue, number of projects and employee growth. Already serving customers from all over the world we also want to set a strong focus
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VelaLabs supports biosimilar development with proliferation assay

Bevacizumab patent protection expires soon

FACES OF CANCER Over 100 types of cancer – a group of diseases involving abnormal cell growth with potential of invading and spreading into other parts of the body – affect about 100 million people worldwide, with over 8 million deaths anually. The risk of cancer increases with age and is more likely in developed
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Old woman - brain - puzzle - alzheimer

Aducanumab – first new treatment approved for Alzheimer’s since 2003

Alzheimer disease: Alzheimer’s is responsible for 60% of the world’s estimated 50 million dementias. The heterogeneity of the disease makes Alzheimer’s diagnosis and counting the total number of affected people difficult. Every fifth patient has an atypical Alzheimer’s disease, which is often not recognized This progressive neurodegenerative disease starts with microscopic changes in the brain
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Video showing VelaLab's laboratory for ligand binding assays

VISIT the labs – discover Velalabs’ ligand binding services

August 2021: For the characterization of proteins, interaction analysis is essential. See which methods we apply in our laboratory to investigate binding interactions of molecules.  Resulting parameters include kinetics, affinity, specificity, concentration and content. Pharma and Biotech companies can rely on broad experience in providing tailormade applications to help understand binding interactions in detail. Take a look into the laboratories of VelaLabs!   Click HERE for further information on
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New efficacy test for veterinary disinfectants

Laboratorio Control, a reference partner of numerous companies for the analysis of biocidal products, implements a new efficacy test for disinfectants used on the skin in the veterinary industry.   > NEW PHASE 2,2 SKIN TEST FOR VETERINARY INDUSTRY (PT3). PR standard NF EN 17422:2019. The launch of this new quantitative surface efficacy test focuses
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In which foods are furan and its methyl analogs present?

In a recent recommendation, the European Commission calls for the determination of furan and methylfurans. These are process contaminants that form in food during thermal treatment. Consumers ingest furan particularly through coffee and cereal-based foods, but young children are also exposed to furan through jarred or canned ready-to-eat foods. According to the European Food Safety
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Laboratorio Control expands ENAC scope in food and animal feed

Laboratorio Control continues with its work plan focused on offering a wide range of analytical services under ENAC accreditation.   On this occasion, Laboratorio Control expands the ENAC scope in food and feed with the accreditation of mould and yeast count by culture according to ISO 21527-1 and 21527-2. Moulds and yeasts are one of
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Shock for manufacturer of substance-based medical devices

Long awaited, widely feared and stunningly received: The newly published MDCG document 2022-05 poses already suspected and yet very considerable challenges to medical device manufacturers of substance-based medical devices. While the Medical Device Regulation (MDR) 2017 still supported and thus legitimised this type of medical device with the official designation of “substances and combinations of
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Available NOW: Metals speciation for Inorganic Arsenic

There are two different forms of arsenic: organic and inorganic- and Columbia Labs tests for both. Inorganic arsenic is highly toxic and is therefore a public health concern; the organic form (commonly found in fish and seafood) is less harmful. The main source of exposure to inorganic arsenic is food; particularly grain-based processed products such
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Updated Analysis: Allergen Testing: More Savings, More flexibility

Allergen testing at Columbia Labs just got more affordable. Columbia Laboratories now offers allergen testing as either qualitative or quantitative, to cut costs and encourage routine monitoring. Allergens infiltrate the food supply at several control points, so routine testing of products AND their environment is KEY to keeping them out of your product line. Allergens
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Infusion from coffee leaves – Authorization as novel food

On occasion of the current discussions in DIN Tea, we would like to inform about “coffee leaf tea”. In addition to coffee cherry pulp (see News from 02-2022), the European Union has authorized an infusion from coffee leaves as a novel food (traditional food from a third country) in the EU. This product can already
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Laboratorio Kudam obtains Norovirus and Hepatitis A analyses accreditation

Laboratorio Kudam obtains ENAC accreditation for Norovirus and Hepatitis A testing in certain foods and bottled water. Tests are performed using the real-time PCR technique. Laboratorio Kudam continues its commitment to quality and the continuous improvement of all its analytical services and has therefore extended its ENAC accreditation for the following microbiological tests in food
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New Management at bilacon GmbH

For more than 30 years, bilacon has been supporting customers in the field of food, feed, food supplements and cosmetics with an extensive, accredited analytical spectrum. bilacon combines the competences of sensory, instrumental, chemical-physical, and microbiological analysis under one roof and answers all questions concerning the safety of your products. In April 2022, the management
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Fumigants – a more curse than a blessing? Are there alternatives?

The use of ethylene oxide in cereal products and spices repeatedly leads to massive recalls in the international trade. Due to the strict requirements regarding phytosanitary import controls, fumigants are currently the only effective alternative to prevent the introduction and spread of pests from importing countries. Thus, fumigation of containers for shipment, as well as
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