Microbiological and molecular biological analysis
Stockholm, Sweden · Nordic Bioanalytical AB
Quick answer
This service in Stockholm, Sweden provides TAMC / TYMC. Reference price: 50,000 to 100,000 SEK per sample.
Capabilities
Nordic BioAnalysis AB offers microbiological and molecular biological testing to support pharmaceutical, biotechnology and medical device companies with product development, quality control and compliance. Our services include testing of raw materials, intermediates, finished products and environmental monitoring. All analyses are performed in accordance with cGMP for pharmaceuticals and in line with ISO 17025 where applicable. The methods are performed using validated protocols and can be customized to meet customer-specific regulatory or technical requirements. Our services are suitable for companies operating in pharmaceuticals, medical devices, biologics and related fields. The analyses support activities such as batch release, microbial contamination control, water system monitoring and molecular characterization in research and development. Our microbiology services include a wide range of tests used to evaluate microbial contamination, verify product sterility, and monitor manufacturing environments. Product and raw material testing Bioburden (aerobic, anaerobic): Count of viable microorganisms in a sample. TAMC / TYMC: Determination of total aerobic microorganism count and yeast and 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 the effect of disinfectants on relevant surfaces or equipment. Dose review for sterilization by irradiation: Control of the applied sterilization dose during irradiation (e.g. assessment of the level of bioburden). Incubation of biological indicators: Monitoring and verification of sterilization processes using indicators. Monitoring bacterial growth curves: Observation of microbial growth dynamics under controlled conditions. Environmental and facility monitoring Environmental control and monitoring: monitoring of viable and non-viable particles in controlled environments through air sampling, swabbing of surfaces and equipment, and personnel monitoring. Use of contact plates, sedimentation 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).
Location & contact
Reference pricing
| Type | Service |
|---|---|
| Technique | TAMC / TYMC |
| Research areas | N/A |
| ISO / certificates | GMP certified |
| City | Stockholm |
| Country | Sweden |
| Provider | Nordic Bioanalytical AB |
| Reference price | 50,000 to 100,000 SEK / sample |
Similar facilities in Stockholm
- GMP-compliant LC-MS/MS instrumentation (Nordic Bioanalytical AB)
- In Vivo PK/PD Studies in Rodents (Truly Lab AB)
- Extracellular vesicle development and manufacturing -both GMP and non-GMP (NorthX Biologics)
- Illumina NextSeq 2000 — Next-Generation Sequencing (Illumina)
- Nunclon Sphera 3D culture system (Thermofisher)
- scRNA-seq Data Analysis & Visualization (SingleCell Discovery)