custom method development
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The continuous emergence of novel programs for biologics and vaccines has resulted in the need for specialized and customized methodologies to aid in meeting the technical and regulatory challenges encountered during development.
Charles River Biopharmaceutical Services (BPS) has over 25 years of experience in method development. Our expert technical staff will support you in meeting new or changing requirements with assay design, development, optimization and validation, as well as routine testing or technology transfer. The assays are customized to your needs and include molecular, cell-based, in vivo, virological and protein-based assays. Technology transfer of assays to or from our locations can also be performed.
The unique challenges of a client’s novel system often require assays in the following areas:
Molecular Methods
- Quantitative PCR (qPCR) and RT-PCR
- High-quality DNA sequencing
- New viruses found in existing and novel production systems
- Adventitious agents
- Residual DNA from unusual host cell species (by qPCR, the Threshold® System or hybridization)
- Microbial and mammalian cell line characterization – identification and genetic stability by comparative sequence analysis (DNA and RNA), restriction endonuclease analysis and copy number cell line identity and purity
Cell-Based Methods (Bioassays) and Virological Methods
- Potency assays
- Binding assays
- Proliferation, survival and competition assays
- Cell-based assays for detection and quantification of specific viruses
Protein Methods
- Host cell protein assay development
- ELISA
- Immunoligand assay (ILA)
- Activity assays
- 1D and 2D gel electrophoresis and Western blotting
- HPLC methods (size exclusion, reverse phase and peptide mapping)
- Capillary zone electrophoresis (CE)
In vivo Assays
To check which of our BPS facilities offer custom method development services, click here. For additional information, please contact us at askcharlesriver@crl.com.
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method development, assay design, assay development, assay optimization, assay validation, technology transfer, tech transfer, molecular assays, cell-based assays, virological assays, protein-based assays
Method Development | Charles River Biopharmaceutical Services
Charles River's Method Development groups will support you in meeting novel or changing requirements with assay design, development, optimization and validation, as well as routine testing or tech transfer.