The path from a newly discovered substance to a marketable drug is long and arduous - only about 10 percent of all substances discovered make it successfully through the approval procedure. Every single step involved in the drug development process is strictly controlled by regulatory agencies such as the American FDA or the European EMEA. The regulations require a substance to be accurately characterised chemically before it can enter the market. Pharmaceutical companies, and in particular small biotechnology companies, often do not have the expertise required to carry out a complete analysis of their antibody or (glyco) protein products. In such cases, M-Scan GmbH, which relocated to larger premises inside the Freiburg BioTechPark in 2007, is the specialist of choice. Using mass spectrometry and other complex analytical techniques, the M-Scan experts are not only able to determine the amino acid sequence of a protein, or clarify the sugar structures of a glycoprotein, they are also able to detect and characterise any other modifications (what are known as post-translational modifications, PTMs) or impurities. Drug development companies have to present such data to the regulatory authorities when applying for marketing authorisation of a drug. In order to carry out these analyses satisfactorily, they have to be carried out in compliance with GMP - Good Manufacturing Practice - standards. "The GMP certificate now enables us to offer services with a guaranteed quality standard," said Dr. Matthias Berg, laboratory manager at M-Scan GmbH.

The term GMP refers to standards that have to be put in place to guarantee the quality of all processes involved in the manufacture of drugs, active ingredients and medical devices. Assuring the consistent quality of drugs is of key importance so that the health of consumers is not adversely affected. There are legal requirements which state that every aspect of the processes involved in drug manufacture, from research to pre-clinical development and finally to the clinical testing of the drug, must be controlled and documented with the utmost accuracy. M-Scan GmbH can analyse the chemical structure of a substance and test it for potential impurities. In addition, M-Scan GmbH can provide support to companies for the control and validation of the quality of the manufacturing process of an approved drug, even 10 years after authorisation to sell the drug has been obtained. “We are able to support our clients all the way from the initial development steps to the appearance of the drug in pharmacies,” said Andrew Reason, managing director of M-Scan GmbH. The GMP certificate now guarantees that the company’s analyses are compliant in all respects with the quality standards set by the German as well as international regulatory authorities (BfArM, EMEA, FDA, etc.)

It is worth noting that it is not that easy to obtain GMP accreditation. In order to be granted GMP status, M-Scan GmbH had to design every single aspect of the drug analytical process according to very strict criteria. Each individual step, starting with the arrival of the sample at the company, to all the processes involved in the analysis, needs to be documented in the company's standard operating procedures (SOP) and must be scrupulously followed. The staff member carrying out an analysis must accurately document every single activity in such a way that national or international authorities are able to trace the individual steps of the analysis even ten years after the manufacture of the drug. In addition, GMP certification requires the company to test and confirm all equipment as suitable for use as well as validating the operation of the equipment (calibration, system suitability test) in order to demonstrate that the analyses produce exact results consistently. This not only concerns the complex devices used for the analyses, but all other devices in the laboratory. "In order to validate the cooling efficiency of a refrigerator where samples are stored, simply putting a thermometer in the fridge is not sufficient," said Berg. "The fridge needs to be mapped, i.e. divided into small squares and the temperature of each individual square has to be recorded with a calibrated data logger." The GMP stipulations are detailed and wide-ranging and the amount of work associated with their compliance is immense. M-Scan GmbH is an exemplary model for other companies in that it successfully cleared this important hurdle only 18 months after starting operations. This achievement is particularly impressive given that the company adapted its manufacturing process to GMP regulations without stopping its day-to-day operations.

“The fact that the other laboratories of the M-Scan group (England, Switzerland, USA), which was founded in 1979, had already received GMP certification certainly helped M-Scan GmbH in obtaining GMP certification so quickly,” said Reason. “These companies already have a great deal of experience of contract analyses following GMP standards.” With the GMP certificate, the Freiburg subsidiary of the M-Scan group is now on an equal footing with other subsidiaries in the growing German and European markets. Company executives are already discussing future investments given that there is room for further expansion at the Freiburg BioTechPark premises. “One possible area of expansion is the testing of protein samples in terms of what are known as aggregates,” said Reason. “Antibodies tend to bind to each other and form insoluble aggregates.” In order for M-Scan GmbH to be able to offer such analyses, a special detector would be required. “For a young company like M-Scan GmbH, the acquisition of such a device would be a considerable financial investment,” said Berg. “However, purchasing such a device would mean that we could expand our protein characterisation portfolio through the use of another important method and would be able to offer our clients the entire protein characterisation package from one source.”

Further information:
Dr. Matthias Berg
M-Scan GmbH
BioTechPark Freiburg
Engesserstr. 4a
79108 Freiburg i.Br.
Tel.: +49 (0)761/611 677-60
Fax: +49 (0)761/611 677-66
E-mail: services.de@m-scan.com