Quality Control

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.

Contact Us

Contact Information

info@biostemlife.com
(954) 380-8342

Location

2836 Center Port Circle
Pompano Beach, FL 33064

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