Choosing and validating modern microbiological methods

Published: 16-Mar-2017
Analysis

Advanced medical therapies require equally advanced microbial methods for QA and QC. Axel Schroeder, Operations Director at Concept Heidelberg, looks at the regulatory background and implementation of rapid methods

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Scientific progress in the field of cellular and molecular biotechnology has led to a fast development of biopharmaceuticals, tissue engineered applications and advanced therapy medicinal products (ATMPs).

The safety of such novel technologies, products and applications is very important. One area for risk assessment and safety is the detection, prevention and control of contamination from microorganisms or mycoplasmas.

Many modern biopharmaceutical products are based on large molecules, cells or tissues that have a complex structure. Thus the classic compendial microbiological test methods are often not suitable for these substances and products.

Additionally, many modern therapeutics have a short shelf-life. Therefore, it is essential to receive results well before the end of their shelf-life.

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