Founded in 1973, BioChem GmbH is an independent family-owned analytical contract laboratory, located in Karlsruhe, Germany, offering high quality laboratory services and competence in all areas of
- molecular biological
testing for the pharmaceutical, chemical, medical and cosmetics industry.
The area of expertise covers quality control release testing, analytical development activities, EU-reanalysis and ICH-stability testing of raw materials or finished products of all dosage forms and additionally allows BioChem GmbH to analyze cytostatics and narcotics.
We provide analysis according to Ph. Eur., USP, JP, BP, HAB, DAB, AMG, MPG, ChemG, OECD and EC directives as well as other specific national, international or customer-specific requirements.
As your business partner and internationally-oriented, modern full service provider BioChem GmbH continuously off er competent solutions for your projects.
Our scientific and practical experience combined with technical competence of more than 60 highly trained experts on board guarantee a maximum of quality, safety and efficiency.
BioChem GmbH is GMP-/GLP-certified as well as FDA-inspected and registered.
OUR PERFORMANCE – YOUR BENEFIT
What is your advantage in using our service?
Simply spoken: You will succeed with your project because:
- you will be in direct contact with our respective experts
- our huge expertise gained over years by a multitude of similar challenges is available to you
- if timelines are short, we support you overnight and weekends
- we act and react fl exibly
- we take care about solving any situation
- you participate in our broad network of professionals
What are our core competencies?
BioChem`s strongest and first core competence can be traced back to the early days in the 70´s – the Microbiological Testing of a variety of samples.
Sterility, bacterial endotoxin, microbiological contamination, identification of microorganisms, efficacy of antimicrobial preservation, microbial assay of antibiotics, environmental monitoring, detergent and disinfectant efficacy, testing of biological indicators or microbial container closure integrity testing are the main well established standard applications and are complemented by hygiene testing of client facilities or evaluation of media fills, just to mention some.
Our clients also appreciate BioChem`s extensive experience in competent advisory service in all kinds of microbiological relevant topics regardless in which phase of product life cycle their project stays.
The second strong core competence with more than 30 years of history can be found within the Analytical Department.
Starting in the 80´s, BioChem took over more and more quality control release testing and analytical development activities as well as EU-reanalysis and ICH-stability testing of raw materials or fi nished products of all dosage forms.
Our four main areas of expertise within the Analytical Department are physico-chemical testing, elemental analysis as e.g. AAS, chromatographic analysis by HPLC, GC, HS-GC, TLC or IC and stability testing according to ICH guidelines including special storage conditions as e.g. 25°C/40% r. h..
The youngest but most upcoming third strong core competence started in the late 90´s and belongs in the Molecular Biological Department.
At BioChem, you will fi nd a wide-spread portfolio of different molecular biological procedures and technologies such as PCR-analysis of microorganisms and viruses, DNA-, DNAse-, RNA-, RNAse-detection, DNA-, ATP-, protein-quantitation, molecular weight determination, protein analysis and immunochemistry, identifi cation of microorganisms and genetically modified microorganisms and plants as well as capillary electrophoretic analysis.