Microbiological and Molecular Biological Analysis
Nordic BioAnalysis AB offers microbiological and molecular biological testing to support pharmaceutical, biotechnology and medtech companies with product development, quality control and compliance. Our services cover testing of raw materials, intermediates, finished products and environmental monitoring.
Regulatory compliance
All analyses are performed in accordance with cGMP for medicinal products and aligned with ISO 17025 where applicable. Methods are executed using validated protocols and can be adapted to meet customer-specific regulatory or technical requirements.
Applications and industries served
Microbiological methods
Our microbiological services include a broad range of tests used for evaluating microbial contamination, verifying product sterility and monitoring manufacturing environments.
Product and raw material testing
- Bioburden (aerobic, anaerobic): Enumeration of viable microorganisms present in a sample.
- TAMC / TYMC: Determination of total aerobic microbial count and yeast/mold count.
- Endotoxin testing: Quantitative and qualitative detection of bacterial endotoxins in products or components.
- Absence of specified microorganisms: Verification that defined microbial species are not present.
Microbiology / quality control
- Method suitability testing: Assessment to ensure that the test method is suitable for the product matrix.
- Growth promotion testing: Verification that culture media support the growth of target organisms.
- Disinfectant studies: Testing of disinfectant efficacy on relevant surfaces or equipment.
- Dose audit for sterilization by irradiation: Control checks on the applied sterilization dose during irradiation (eg. assess bioburden level).
- Incubation of biological indicators: Monitoring and verification of sterilization processes using indicators.
- Bacteria growth curve monitoring: Observation of microbial growth dynamics under controlled conditions.
Environmental and facility monitoring
- Environmental controls and monitoring: monitoring of viable and non-viable particulates in controlled environments through air sampling, surface & equipment swabbing and personnel monitoring. Utilizing contact plates, settle plates, and air samplers to ensure compliance with GMP and cleanroom classification standards.
- Identification of microorganisms: classification of isolated microorganisms using advanced phenotypic and genotypic methods, including MALDI-TOF mass spectrometry and nucleic acid sequencing (e.g., 16S rRNA or ITS2 region).
Molecular biological methods
Our molecular biological services support analytical needs within DNA and RNA analysis, sequence-based identification and molecular technique development. Analyses can be performed as part of internal research, quality evaluations or project-specific investigations.
Polymerase Chain Reaction (PCR) analysis
Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDS-PAGE)
Western blot assay (Immunoblotting)
Enzyme-Linked Immunosorbent Assay (ELISA)
Detect and quantify proteins, antibodies, hormones, antigens, and other biomolecules in a sample.