Innovation Europe > News > Innovation EU Vol2-1 > Mycosafe Diagnostics

The Mycoplasma Specialist in Bioquality and Bioanalytics

The growing market of biologicals, biopharmaceuticals, cell therapy and tissue-engineered products requires an increasing need of expertise in the area of mycoplasma biosafety assurance in compliance with regulatory requirements. Mycosafe is worldwide one of the few suppliers specialised in this area.

Solutions for the Control and Prevention of Mycoplasmas in Bioscience and Biopharmaceutical Processes

Mycosafe is a GMP-certified company specialised in contract mycoplasma testing services for the mycoplasma biosafety and prevention control of cell lines and associated biological and biopharmaceutical products, including vaccines and cell therapy applications. Based on its long-standing experience and expertise in Mycoplasmology, Mycosafe represents a Center of Excellence for providing mycoplasma testing and related R&D, validation and consultancy services with particular attention to the stringent regulatory requirements and individual project needs of its clients in the biopharmaceutical and biotechnology industry.

Experience, Quality and Reliability in Industrial Mycoplasmology

The mission of Mycosafe is to advance the development and production of biological medicinal products by assisting biotechnology and biopharmaceutical companies to comply with the stringent mycoplasma biosafety requirements of the international regulatory authorities. Mycosafe offers a broad range of mycoplasma testing, R&D, consultancy and educational services to address these demands. Clients of Mycosafe benefit from its high-quality individual customer care and from its high level of scientific and regulatory experience in the management of mycoplasmas in an industrial environment.

Mycosafe - Scientific and Regulatory Know-How and High-Quality Individual Client Care

The fundamental basis for success at Mycosafe is its scientific and regulatory expertise and profound professional commitment in all areas of Industrial Mycoplasmology combined with a maximum level of individual client care. By offering its expertise and handling of projects with maximum high-quality care, Mycosafe can assist its clients in their quality control, product development and lot release needs.

Mycosafe - Internationally Recognised Expertise and Long-Standing Experience in Basic and Applied Mycoplasma Research

Mycosafe was founded in December 2003 in Vienna, Austria, by the internationally renowned mycoplasma expert Professor Renate Rosengarten as spin-off company of the Institute of Bacteriology, Mycology and Hygiene (IBMH) at the University of Veterinary Medicine Vienna (VUW). Since its foundation, Mycosafe has established itself as a leading contract service company providing quality control mycoplasma testing of cell lines and biologically derived products as well as research services to the biotechnology and biopharmaceutical industry worldwide. Based on its profound expertise in the area of Mycoplasmology, Mycosafe has continuously expanded its range of services to become a supplier for all kinds of services related to the detection, prevention and control of mycoplasmas in bioscience research and in biotechnological and biopharmaceutical processes.

Mycosafe - High-Quality Standards and Compliance with GMP Requirements

Being an international service provider of quality control mycoplasma testing of cell lines and biological and biopharmaceutical products, BSL 1, 2 and 3 laboratories of Mycosafe operate according to the highest quality standards. Most of the services performed by Mycosafe’s well-trained staff are in strict compliance with GMP to meet the needs of its clients and the regulatory expectations worldwide. Several inspections by regulatory authorities as well as client audits have confirmed the high-quality standards of services at Mycosafe and their compliance with international GMP requirements. These regular inspections assist Mycosafe to continuously improve its quality system. By providing all services with the necessary scientific and regulatory expertise and experience, Mycosafe helps its clients to reduce costs and to meet customer and market demands.

GMP-Compliant Customised Mycoplasma Biosafety Testing and Test Validation Services

In close cooperation with its clients, Mycosafe has conducted over the years a few thousand regulatory compliant mycoplasma biosafety tests on all relevant process steps. Some of these tests have been individually designed as client-specific assays. A main focus of the current activities at Mycosafe is the co-development and performance validation of rapid mycoplasma detection assays based on nucleic acid amplification techniques (NAT) which represent promising future applications for routine mycoplasma biosafety testing of a number of biological and biopharmaceutical products. As the method performance and product-specific validation of these new NAT-based mycoplasma detection assays prior to their use in routine mycoplasma testing require a high level of scientific accuracy, Mycosafe has developed well defined mycoplasma culture and DNA reference standard preparations of very high quality which allow an objective comparison of the various test systems.

Mycosafe Diagnostics GmbH
Veterinaerplatz 1
A-1210 Vienna, Austria
Tel: +43 1 25077 2150
Fax: +43 1 25077 2190
E-mail: office@mycosafe.com
Website: www.mycosafe.com

Mycoplasma Biosafety Expertise in Vienna, Austria

Mycosafe is a GMP-certified company based in Vienna – Austria which is worldwide one of the few suppliers specialised in mycoplasma biosafety assurance and prevention control of cell lines and biological and biopharmaceutical products, including vaccines and cell therapy applications. Mycosafe’s state-of-the-art laboratories include S2 and S3 facilities allowing mycoplasma biosafety testing of biological samples containing BSL2 and BSL 3 agents.