Molecular Biology
Our molecular biological services
BioChem´s molecular biological laboratory offers:
- quality control release testing
- EU reanalysis
- molecular biological method
- development
- optimization
- validation/verification
- PCR analysis of MOs and viruses
- DNA, DNAse, RNA, RNAse detection
- DNA/ATP/Protein quantitation
- molecular weight determination
- protein analysis and immunochemistry
- identifi cation of MOs, GMOs and plants
- capillary electrophoretic analysis
- registration support/expert opinion
for all pharmaceutical
- finished dosage forms
- intermediates
- excipients
- raw materials
as well as
- chemical
- medical
- cosmetic products
including
- cytostatics
- narcotics
Molecular Biological Equipment and Technologies
Our state-of-the-art equipped molecular biological department offers a variety of modern technologies supported by a broad range of high-tech instruments including:
- (q)PCR Cycler
- micro plate reader
- photometer
- fluorometer
- luminometer
- electrophoresis
- capillary electrophoresis
- isoelectric focusing
- SDS-page
- gel-electrophoresis
- gel documentation system (CCD)
Within our molecular biological laboratory – biosafety level S1 and S2 – our highly qualified and motivated team handles GMOs. Please contact us before sending us biosafety level 2 GMOs, as German authorities provide their permits on a project-by-project basis only.
Pharmacopoeial Techniques
For years we have been successfully using several pharmacopoeial techniques such as:
- enzymatic assays for activity determination
- immunological assays
- protein/DNA/RNA identification and quantitation
using
- isoelectric focusing
- SDS-page
- Bradford/Lowry
- ELISA/EIA,
- nucleic acid amplification technique (NAT)
Microorganisms, Viruses and DNA- Fragments
We offer customer-specific individual solutions for identification and quantitation of
- microorganisms including GMOs or pathogenic germs
- human, animal and plant relevant viruses
- customer-specific DNA fragments
Detection of mycoplasmas out of cell cultures and validation according to current pharmacopoeial requirements are common well established practises.
As specialists in (q)PCR / RT-(q)PCR technologies we are able to perform highly specific analysis with a minimum of sample amounts.
Medical Device and Lab Device Testing
One of our core competence focuses on testing of medical devices and lab supplies e.g. pipette tips, microwell plates, reaction or PCR tubes as well as stents for absence of DNA/DNAse/RNA or RNAse as it is required by several directives and guidelines.
Start -Up or Global Player
Depending on your project-specific requirements and irrespective of the life-cycle status of your product, BioChem and its highly experienced staff accompany and guide you through tasks related to research, development, production or marketing.
