Quality Control Testing

We perform your mycoplasma analysis under GMP conditions using rapid microbiology methods. Various sample preparations are combined with qPCR – independent of plate-based culture methods, extremely fast, and EP/USP/JP-compliant. Background: Mycoplasma are cell wall-less, filterable bacteria (~0.15 µm), often antibiotic-resistant and relevant contaminants in cell cultures.

We test samples in a GMP environment using qualitative real-time PCR for defined viruses—e.g., for in-process controls or batch release of biological materials. The service includes extraction of viral nucleic acids and subsequent PCR. Note: No testing of clinical samples. Preventive testing (e.g., coronavirus screening) and ATMP support available on request.

Endotoxins (LPS from gram-negative bacteria) can trigger strong pyrogenic and immunological reactions. The testing of GMP-relevant raw materials and final products, such as those intended for parenteral applications and medical devices, is required by the pharmacopoeia and can be performed in our laboratory using the methods described in EP 2.6.8 or 2.6.14.

Vector copy number (VCN) is central to R&D, clinical trials, and LOT release—e.g., in recombinant protein expression, model creation, or ATMP/GTMP. We develop/validate qPCR duplex systems or validate our in-house system for your matrix.

As part of matrix validation, we demonstrate that your specific matrix is compatible with our methods. The scope and parameters are based on the pharmacopoeia/ICH, your risk profile, and regulatory requirements (coordination recommended). Limit tests can be used to check EP limits, robustness (across 3 batches), and, if necessary, statistical methods (e.g., Probit for LOD95).