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Biologics Testing

Evaluating the identity, stability, purity and safety of biological products is critical during development and biomanufacturing. To provide you with the best solutions, we use a broad range of molecular biology techniques including qPCR, sequencing, southern blot, northern blot and microbiological applications.

Service Offerings

Technology Platforms

qPCR
Real-Time qPCR

The multitude of Beckman Coulter Genomics qPCR services are built upon a state-of-the-art ABI PRISM* 7900HT qPCR Sequence Detection System platform. The 7900HT System is a real-time qPCR system that detects and quantitates nucleic acid sequences in a high-throughput mode suitable for the requirements of today’s drug discovery process. Using the 7900HT System, Beckman Coulter Genomics can accommodate any real-time qPCR need with standard or customized TaqMan* assays.

With the 7900 HT qPCR platform, Beckman Coulter Genomics can deliver:

  • Residual DNA testing
  • Biodistribution studies
  • Cell Bank Characterization
  • Custom qPCR solutions
  • High throughput capacity
  • Research and Regulated services
southern blotting
Southern Blotting

As part of its genetic stability testing panel, Beckman Coulter Genomics offers the traditional Southern blotting technique. A probe specific to the gene of interest is generated by PCR amplification or restriction digestion, then radioactively labeled with a-32-p-dCTP. Total DNA is extracted from the test articles and host cells using organic extraction methods, then digested with appropriate restriction enzymes that cut predictively within the expression cassette and randomly within the host genome. Restriction fragments are electrophoresed on agarose gel, denatured, transferred to membrane, and hybridized to radiolabeled probe. Band densities are visualized using an Alpha imager and quantitated using spot densitometry.

Beckman Coulter Genomics’ Southern blotting platform services include:

  • Confirmation of structure maps
  • Determination of number of integration sites
  • Analysis of construct copy numbers
  • Sensitivity down to 0.1 pg target DNA

† The PCR process is covered by patents owned by Roche Molecular Systems, Inc.,
and F. Hoffman-La Roche, Ltd.
* All trademarks are property of their respective owners.
Beckman Coulter and the stylized logo are registered trademarks of Beckman Coulter, Inc.
biologics testing