The Quality Control Department at BioStem Life Sciences is comprised of highly qualified personnel who work to provide a comprehensive range of analytical testing services to ensure product consistency and quality throughout all development and manufacturing stages. Quality Control is also responsible for the testing of samples generated during the process development phase of a project or when required during a clinical production run. BioStem's QC staff also has the experience to develop, qualify, and validate product-specific assays tailored to meet client needs.
Network Assay Capabilities
HPLC quantitation
UV/Vis spectrophotometric assays
Identification testing
PCR assay development capabilities
SDS-PAGE, western blot
ELISAs for residual host cell proteins, host DNA/RNA, process impurities
Flow cytometry assay development capabilities
Protein-protein interaction analysis
Microbiological Services
Sterility testing
Antibiotic sensitivity studies
Microbial limits/bioburden studies
Cell count determination
Personnel/Environmental Testing
Viable and non-viable air particles
Surface monitoring
Settling plates
Quality Control Laboratory
The BioStem Quality Control Laboratory consists of a main lab space with two adjacent controlled rooms that are used for specialized cell culture and microbial assays.
QC Main Lab contains equipment for analysis of process development and final product samples.
Attune Flow Cytometer
Qubit fluorometer
Countess II Automated Cell Counter
ChemoMetec NC-200 Nucleocounter
Sysmex Hematology Analyzer
QC Cell Culture Lab contains equipment for performing mammalian cell-based bioassays and is maintained at a positive pressure relative to surrounding areas to assure a clean environment for doing cell culture work.
Have questions? Reach out to us
If you have questions about the company, our lab, our scientific team or anything else, please feel free to contact us.
