Gene Therapy (Adenovirus):
Endpoint Dilution Infectivity Assay:
Development and validation of Excel spreadsheet to carry out data analysis.
Confirmation of the validity of the endpoint dilution maximum likelihood data model.
Assay validated over 3 logs of infectivity.
Plaque Assay:
Plackett-Burman experimental design to demonstrate robustness.
Diffusional correction calculations.
Clinical Assays:
Infectious rAd5 in blood samples.
Neutralizing antibody attenuation of rAd5 infectivity.
Total antibody assay.
Clinical assays were validated.
Quantitation of replication-competent adenovirus.
Proteins and Enzymes:
Enzyme activity analytical development:
Myeloperoxidase reaction mechanism-based assays.
Glucose oxidase, serum protease, arginine deiminase activity assays.
Enzyme reaction progress curves fit to enzyme catalysis models.
Betaseron Neutralizing Antibodies:
Statistical model for titer calculation.
Assay was validated.
Statistical analysis of common neutralizing antibody assay (Berlex, Serono, Biogen).
Growth Factors:
Quantitating cell culture production.
Clinical assay: statistical analysis of LOQ and LOD.
Statistical analysis of outliers in clinical assay.
Potency Bioassay:
4-Parameter nonlinear least squares curve fitting.
Parallel curve analysis comparing sample with reference standard.
Development of Excel spreadsheet to perform data analysis.
Confirmation of data analysis by SAS.
Statistical Analysis and Technical Reports:
Taqman qPCR:
Adenovirus quantitation.
Quantitation of endogenous virus concentration.
Host cell DNA quantitation.
Cell Therapy:
Statistical analysis of cryopreservation protocols.
Stability of frozen cell preparations.
Statistical analysis of culture conditions.
Statistical tools:
SAS, MiniTab, JMP.
Control charting bioassays to evaluate ongoing state of control.
Statistical analysis of robustness, precision, and accuracy in assay validation.
Design of experiments, robustness testing, Plackett-Burman.
OOS data analysis for retesting strategies.
ODBC data extraction.
Stability of Biologicals:
Design of stability programs and protocols.
Statistical analysis of stability data of multiple lots.
Adenovirus stability (at two companies).
Cytokine stability report for NDA.
Statistics and Fitting Data to Model:
4-Parameter fit with parallel curve analysis for potency bioassays.
Poisson/Binomial distribution fit to endpoint dilution infectivity assay model.
Neutralizing antibody attenuation of infectivity of adenovirus.
Neutralizing antibody to biological activity of therapeutic proteins.
Statistical thermodynamic models of site-dependent binding of drugs to oligonucleotides.
Enzyme reaction progress curves fit to enzyme catalysis models.
Databases and Data Management:
LIMS:
Upgrade, migrate, and validate Applied Biosystems SQL*LIMS to Version 4.0.
Configure and validate Qumas controlled documentation management system.
Database Design:
Develop and implement Technical Reports electronic database and report repository.
Develop and implement Microsoft SQL Server QC results database.
Corrective Actions tracking database.
Computer Validation:
Continuous particle measuring system.
Excel spreadsheets for data calculations.
42 Seabreeze Dr.
Richmond, CA 94804
e-mail: Jeff@JeffNelsonConsulting.com
telephone: (510) 235-7657