Product/Service

Monoclonal Antibodies

Source: Abbott
Our state-of-the-art facilities are flexibly configured to accommodate your process requirements. 84,000 square feet of cGMP manufacturing space provides four Class 100,000 fermentation suites, five Class 10,000 purification suites, Class 100 filling hoods and appropriate facilities for all supporting operations, such as material storage, buffer preparation, media preparationand glass wash.

Designed and operated with personnel, product and equipment flow paths geared to regulatory compliance, our facility gives your product the protection it needs. Temperatures in our purification cold rooms can be adjusted up to room temperature to fit your process requirements.

Continuous monitoring by our building management system and continual environmental testing ensure that your environmental requirements are met.

Process Development/Optimization
Our process development equipment and personnel are capable of supporting early development needs to commercial product launch.
  • Cell line development
  • Analytical method development
  • Cell culture process development
  • Purification process development
  • Viral clearance studies
  • Process scale-up lab (300 L)
  • Extended product characterization
  • Process characterization
  • Process validation
  • Manufacturing support

Quality Control and Analytical Capabilities
Quality control laboratories are equipped with a broad range of state-of-the-art instrumentation for chemical and microbiological analysis.

  • HPLC (SEC, ion exchange, affinity, reverse phase)
  • Electrophoresis (CE, IEF, SDS-PAGE)
  • ELISA
  • Microbial identification
  • DNA quantification (threshold)
  • DNA identification (PCR)
  • Endotoxin
  • Spectrophotometry (FT-IR, UV-VIS)
  • TOC
  • Oligosaccharide analysis
  • Peptide structure determination (LC/MS/MS)
  • Host-cell protein
  • Bioburden