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 to develop, qualify, and validate product-specific assays tailored to meet client needs. 

Assay Capabilities

• HPLC quantitation of plasmid DNA
• RP-HPLC, SEC-HPLC, IEX-HPLC characterization of biomolecules
• USP <85> LAL test for bacterial endotoxin via kinetic turbidimetric assay
• UV/Vis spectrophotometric assays
• PCR assay development capabilities
  
• SDS-PAGE, Western blot
• Particle sizing and counting
• 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)
• Flow cytometry assay development capabilities
• Additional capabilities through university connections and a network of CROs

Microbiological Services

• Sterility testing
• Antibiotic sensitivity studies
• Microbial limits/bioburden studies
• Cell count determination

Personnel/Environmental Testing

• Viable and non-viable air particles (remote Climet systems)
• 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.

• Shimadzu 1601 UV-visible spectrophotometer
  
• Multiple Agilent 1260 HPLC systems with diode array detector
• BioTek ELX 808 Ultra Microplate reader
• Nanosight NS300
• Applied Biosystems QuantStudio5 quantitative PCR instrument
  
• Sartorius Sartocheck 4 Plus filter integrity tester
• Cellometer Auto 2000 and NucleoCounter NC-200 automated cell counters
• Dedicated mammalian cell culture and microbial culture BSCs and incubators