Quality Control

The Quality Control Department at Waisman Biomanufacturing is staffed by highly qualified personnel who work to provide a comprehensive range of analytical testing services that ensures product quality and consistency during all stages of development and manufacturing. The QC group is also responsible for testing of in process samples generated during the process development phase of a project or where required during a clinical production run. In addition, our QC staff has the experience enabling them to develop, qualify, and validate product-specific assays tailored to meet client needs. 

Assay Capabilities
 
  • HPLC quantitation of plasmid DNA
  • RP-HPLC
  • SEC-HPLC
  • LAL test for bacterial endotoxin via kinetic turbidimetric assay
  • UV/Vis spectrophotometric assays
  • Identification testing
  • PCR assay development capabilities
  • SDS-PAGE, western blot
  • Isoelectric focusing
  • Restriction digest and AGE analysis
  • Identity and quantitation of supercoiled DNA by AGE
  • ELISAs for residual host cell proteins, host DNA/RNA, process impurities (e.g., Benzonase, FBS)
  • Virus titer (qPCR) and plaque assays
  • 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 Waisman 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.

  • forteBio BLItz system
  • BD Accuri C6 flow cytometer
  • Shimadzu 1601 UV-visible spectrophotometer
  • Multiple Agilent 1100 HPLC systems with diode array detector
  • BioTek ELX 808 Ultra Microplate Reader
  • Puffer Hubbard refrigerator and -20C freezer

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.

  • Class II Type B3 BSC
  • Thermo Forma Series II Water Jacketed CO2 Incubator with medical-grade gas supply
  • Nikon Eclipse TS-100 inverted fluorescent microscope
  • Sorvall Legend RT table-top centrifuge for processing samples
  • CFX96 Real-Time PCR C1000 Thermo Cycler

QC Microbiology Lab contains equipment for performing bioassays that require the use of bacteria and is maintained at a negative pressure relative to the surrounding areas to provide containment for bacterial cultures.

  • Class II Type B3 BSC
  • Incubators for performing a variety of testing (e.g. sterility)
  • Puffer Hubbard model IRI-1910A BOD refrigerator
  • Two Haraeus model B12 incubators
  • Nikon Eclipse E400 microscope