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VelaLabs – Meaningful Analytics

 

Analytical Characterization of Biomolecules

VelaLabs was founded in 2006 in the former Novartis Campus in Vienna. Since 2007, it is a GMP-certified service-oriented company with focus on analytical and quality control of biopharmaceutical products, as well as clinical development of biosimilars, biologics and ATMPs. By the acquisition of LABH in 2019, VelaLabs can now also offer all types of microbiological services. Together with its strong team, the VelaLabs Management aims to successfully realize its vision of the future and expand its base of operations.

Among the new goals are digitalization and expansion of its analytical method portfolio for innovative products, as well as GLP certification and ISO 17025 accreditation.

Philosophy

Our philosophy is to support our customers during the journey through the adventure of health.

With our help you have a competent partner in your side for the whole process of drug development that supports you with analytical development, clinical expertise and regulatory consulting.

VelaLabs stands for individual customer support, highest quality standards and professional expertise and we are an international partner for the pharma and biotechnology industry developing biopharmaceuticals and biosimilars.

Our solutions are not out-of-the-box and our flexible and dynamic team can provide tailored solutions for our customers while also having regulatory expertise.

GMP Certification

VelaLabs offers analytical test methods for medicinal drugs in the preclinical and clinical development phase. The analytical portfolio is based on International Conference for Harmonization (ICH) guidelines and covers non-cellular and cellular methods. The portfolio is further completed by advisory support for submission-relevant clinical studies and drug product release.

The most important tool for assuring the quality standards of VelaLabs is the GMP certification, which represents the highest level of quality in the pharmaceutical industry. Furthermore, VelaLabs is working compliant with GCLP guidelines for all bioanalytical services.

Memberships and Cooperation

VelaLabs collaborates with the St. Anna Children’s Hospital, which provides comprehensive care for the children and young people entrusted to them: The concept of the hospital integrates the treatment of patients according to the latest state of medical knowledge, care as support for self-care in close cooperation with caregivers and the psychosocial care of the patients and their families.

VelaLabs is member of Life Science Austria Vienna Region (LISA VR), which provides support and advice to start-ups and high-technology companies.

Vela is partner of the network and cluster of Human Technology Styria.

Biomedica is a leading distributor of medical devices, in-vitro diagnostics and products for Life Sciences. VelaLabs and Biomedica collaborate regarding the implementation, use, marketing and testing services of the GlycoTechnica LecChip technology.

Evercyte offers immortalized cells that retain their primary-like human cell characteristics. VelaLabs and Evercyte have a cooperation for the usage of immortalized cell lines for biosimilar characterization.

Long-term partners of VelaLabs are the Department of Clinical Pharmacology and the Coordination Center for Clinical Studies (KKS) both from the Medical University of Vienna.

BLS – Analytik GmbH & co. KG is a Tentamus laboratory, focusing on the physical, physical-chemical and chemical testing and analysis of pharmaceuticals, food, feed and cosmetic products. BLS is a fully GMP, FDA, and ISO 17025 inspected and approved laboratory.

BAV Institute is an accredited contract laboratory offering hygiene and quality control services in the fields of food, cosmetics, and pharma. In addition to microbial testing, the company specializes in on-site consulting and training.

Protagen Protein Services (PPS) is a leading CRO in protein analytics and its application to GMP-compliant characterization of protein therapeutics. PPS supports multiple biosimilar developers in achieving and demonstrating biosimilarity. Many years of experience of PPS in business and a comprehensive spectrum of validated analytical methods ensure highest quality for customers in the pharmaceutical, biotechnology and life science industry.

MPL Mikrobiologisches Prüflabor GmbH is the GMP certified partner of VelaLabs for microbiological analytics.

Customers

VelaLabs’s customers include some of the biggest names in Pharma and Biotech. Our focused, customer – orientated approach, a highly motivated team and a broad expertise in analytical development and quality control led to a trusting relationship that has met the requirements of our customers for over 10 years.

Pharma

Biotech

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Medinical product or medical device? - Webinar

 March 30, 2021, 3 pm cet     In which category does my product belong? This is often a non-trivial question.   In theory, medicinal products and medical devices can be very appropriately distinguished in terms of their modes of action and thus their medical purposes: while medicinal products exert their effect in a pharmacological, ... Continued

Endotoxin testing by using recombinant Factor C (rFC)

March 2021: As an alternative method for the Limulus Amebocyte Lysate (LAL) VelaLabs now offers endotoxin tests with recombinant Factor C-Test (rFC) – a fluorescence-based assay in a 96 well plate format. Pharmaceutical products and sales are growing and the demand of endotoxin testing increased. In the context of saving the horseshoe crap population VelaLabs has ... Continued
Tentamus España - New Website

Tentamus launches its Spanish Website

The Tentamus Group is happy to announce the launch of the Tentamus website in Spanish featuring all analytical services and industries covered by Tentamus Group: Food & Feed, Agriculture & Environment, Pharmaceuticals & Medical Devices, Cosmetics as well as Agrosciences Services. The new website is aligned with the corporate identity of Tentamus Group and is ... Continued

Risk evaluation of nitrosamines in pharmaceuticals

As of October 2020, EMA and the national competent authorities are asking marketing authorisation holders for metformin-containing medicines to test their medicines before releasing them onto the market. The risk evaluation for chemical medicines should be completed at the latest by 31 March 2021 and 1 July 2021 for biological medicines. If a risk is ... Continued

Ethylene oxide residues still found in sesame seeds

Sesame seeds and sesame products have been recalled from the market many times in the recent past due to ethylene oxide residues. In a recent test, sesame seeds and foods containing sesame were tested and elevated levels of ethylene oxide were still detected in four of 44 products. Ethylene oxide is a pesticide used to ... Continued

Possible faults in vegan minced meat

Worldwide, more and more people live vegan, i.e. they avoid all animal products for various reasons. Therefore, the market for vegan meat alternatives such as vegan minced meat is booming, so that a bolognese or a chili can also be prepared vegan.   Mineral oil components do not taste vegan as well   In a ... Continued

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