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Minerva | Quality Control Considerations and
Trademark Information

 

Quality Control is important in all aspects of cell culture. The quality will affect the quality of products and results derived from them. One area of quality control that is of major concern for cell culture laboratories is the avoidance of microbial contamination.

Avoidance of Microbial Contamination

Biologic products prepared in cell culture substrates are expected to be free of microbial contaminations in order to help assure product safety, purity, potency, and consistency. Appropriate tests should be conducted for microbial contamination that demonstrate the absence of detectable mycoplasma, bacteria and viruses when applicable.

Mycoplasma Infection

Mycoplasma contamination of cell lines and biotherapeutics represents a significant bio-safety concern. The ubiquitous nature of mycoplasma in man, animals, and the environment increases the likelihood of the introduction of these organisms into cell lines or a manufacturing process. Mycoplasma infection can affect virtually every cell culture parameter and may potentially result in decreased quantity or quality of product, inconsistency of manufacture, or possible adverse effects in recipients. So far, mycoplasma contamination remains an under-diagnosed problem and quality control in the field of basic research or drug discovery & development and other areas of research involving in vitro cell culture often falls far short.

Bacterial Infection

Moderate or strong bacterial contamination is generally visible to the naked eye and de­tected by a sudden increase in turbidity and color change of the culture medium as the result of a change in pH. Weak bacterial contamination, however, might not be visible and only a diagnostic test (e.g. PCR) will ensure early detection of bacterial contamination and enable appropriate action.

Virus Infection

A potential source for viral contamination is bovine serum which might carry the bovine viral diarrhoea virus (BVDV). Contamination of cell lines with BVDV may cause slight changes in growth rate but since this virus is non-cytopathic macroscopic and microscopic changes in the culture will not be detected.

Detection Systems

Minerva Biolabs provides preventative and surveillance procedures to guarantee viable, and contaminant-free cell cultures. To meet the need for rapid, accurate, and quantitative diagnosis of mycoplasma, bacteria and viruses, we have developed a highly sensitive PCR methodology. Our PCR-based diagnostic kits are in compliance with Ph. Eur. (European Pharmacopoeia).

 

Minerva Biolabs has developed & implemented quality management systems certified according to the Quality System Standards ISO 9001:2008 & ISO 13485.

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Trademark Information - Limited License and Use

Limited Product Warranty
This warranty limits our liability for replacement of this product. No warranties of any kind, express or implied, including, without limitation, implied warranties of merchantability or fitness for a particular purpose, are provided. Minerva Biolabs shall have no liability for any direct, indirect, consequential, or incidential damages arising out of the use, the results of use, or the inability to use this product.

Notice to Purchaser
Our diagnostic kits are optimized for use in the polymerase chain reaction („PCR”) covered by patents owned by Hoffmann-La Roche, Inc., and F. Hoffmann-La Roche Ltd. („Roche”). No license under these patents to use the PCR process is conveyed expressly or by implication to the purchaser of this product. Minerva Biolabs does not encourage or support the unauthorized or unlicensed use of the PCR process. Use of this product is restricted to persons that either have a license to perform PCR or are not required to obtain a license.

Trademarks
The LightCycler is a registered trademark of a member of the Roche Group. ABI Prism is a registrated trademark of Applera Corporation or its subsidiaries in the US and certain other countries. SmartCycler is a registered trademark of Cepheid. Mx3000p, Mx4000 are registered trademarks of Stratagene. The iCycler is a registered trademark of Bio-Rad Laboratories, Inc. Rotor-gene is a registrated trademark of Corbett Life Science. Scorpions are trademarks of DxS Limited. Venor, Onar, Intego, Mynox, Mycoplasma Off and Aqua Screen are registered trademarks of Minerva Biolabs GmbH.

Limited License - qPCR Detection Kits
The use of these products for the detection of legionella or mycoplasma contaminations for human diagnostics, for legionella in water or for the detection of mycoplasma in biologicals are covered by a Scorpions license from DxS Ltd. The use of Scorpions® Probes for research purposes is covered by a license to Minerva Biolabs GmbH from DxS Ltd. No rights to perform or offer diagnostic, commercial testing or other commercial services for money or money’s worth are granted by the supply of this product. Should you wish to use this product for any other purpose not covered by this license, please contact DxS Limited at Manchester Incubator Building, 48 Grafton Street, Manchester, M13 9XX.

Limited License - Mynox® / Mynox®Gold
The purchase price of this product includes a limited, non-transferable license under German Patent 195 21 938 or its foreign counterpart, owned by Minerva Biolabs GmbH, to use only this amount of the product to practice the Mynox® technique. No right to perform or offer commercial services of any kind using Mynox® is hereby granted by implica tion or estoppel. Further information on purchasing licenses may be obtained by contacting Minerva Biolabs GmbH, Landhausring 7, 12683 Berlin, Germany.

All products and services are subject to the terms and conditions of any applicable contract.

 

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