Enhance Drug Efficacy with Cell-Based Assays
Optimize Drug Efficacy with Pharmaron’s Advanced Cell-Based Assay Solutions
Offerings
Pharmaron’s portfolio of developing and validating a cell-based potency assay offers a solid scientific understanding and state-of-the-art GMP-compliant platforms. Our team has extensive experience working on various molecules and has developed and validated multiple mechanisms of action-based potency assays, as shown in the figure above.
Cell Line Identification
Pharmaron has a bank of numerous cell lines that allows for screening multiple cell lines to identify an ideal specific potency assay.
Screening parameters involve transduction ability, promoter activity, transgene mechanism of action assessment feasibility, endogenous expression level, etc.
de novo Development
If assistance is needed for the mechanism of action/activity assay in vitro, Pharmaron’s team can help design a GMP-compliant assay.
Method Transfer
Has a method been established already? Pharmaron can help transfer the method directly to our GMP team for validation and lot release testing.
GMP Qualification and Validation
An end-to-end capability for method development to GMP validation to support late-phase clinical trials and regulatory submission.
Lot Release Testing
A dedicated GMP team and suite to support clinical or commercial lot testing. Pharmaron works with commercially approved products, including the first approved gene therapy drug in the United States.
Transfer to GMP Checklist
Transferring an assay to a QC/GMP lab is sophisticated and complex. Numerous scientific and nonscientific variables must be considered for successful transfer, including the status of the method (robustness, accuracy, and precision) and the availability of critical material, reagents, and compliant platforms. Find out more by discussing this with an expert.
Phase Appropriateness
Potency assay evolves with the development of the process, the progress of clinical studies, and the ever-changing landscape of innovative technology. As a product progresses through various stages of development, the potency assay becomes more rigorous and robust. Regulatory agencies recommend applying a phase-appropriate format and compliance rigor. Stage-appropriate validation can reduce resources and budget burdens while ensuring regulatory compliance. Find out more by listening to our webinar.
Resources and Technical Support
