lexartys Can help develop, optimizE, troubleshooT, and validatE Your assays to support Program advancement and regulatory filings
Lexartys has extensive hands-on experience helping sponsors bridge the gap in transferring GLP-compliant assays to cro laboratories
We can also help with setting or evaluating bioanalytical strategy, including phase-appropriate assay life cycle management as well as project management
We have the capability to supporti multiple aspects of program development uTILIZING the following platforms to generate high quality pharmacokinetic (PK), toxicologic (Tox), Pharmacodynamic (PD), and immunogenicity data
Ligand-Binding Assays
Colorimetric and Electrochemiluminescent Assays
LC-MS/MS
HPLC / UPLC
Flow Cytometry
qPCR Analysis
Immunogenicity Risk Assessment and Monitoring
immunogenicity assessment is required for all biopharmaceutical and most peptide therapeutic programs, to ensure patient safety and efficacy
the fda has requested providing an immunogenicity risk assessment for each product submission
an effective risk assessment identifies the factors unique to your drug that may contribute to the development of an immunogenic response, and how this response will be monitored
lexartys can work with you to either develop an assessment of immunogenicity specific to your program, or review your current assessment and provide A gap analysis. including:
Intrinsic and Extrinsic Immunogenicity
Target Indication and Patient Health Status
Bioanalytical and Analytical Characterization
Preclinical and Clinical Study Design and Results
Post-Marketing Committments
Critical Reagent Management
Sensitive and specific bioanalytical assays are highly dependent on quality reagents.
Proactive material planning with consideration for stability and READY supply can reduce or eliminate costly mid-study adjustments to address lot-to-lot variability in critical reagents
Lexartys can help with mapping out your reagent requirements from early stage discovery efforts to long term, large clinical trial support
We also have extensive experience in custom antibody generation campaigns, ensuring high quality antibody is available for the lifetime of your program:
Surrogate polyclonal antibody generation for use as a positive control in immunogenicity assays, including ADA and NAb assays
Monoclonal antibody generation for use in immunogenicity assays or as well-characterized capture and/or detection reagents to produce highly sensitive PK, PD, and immunogenicity assays
Medical Writing and Project Management
succinct, quality medical writing is critical to facilitating rapid review of regulatory submissions
lexartys has extensive experience working effectively with highly matrixed organizations, providing assistance with some of the areas of development subject to bottlenecks, including medical writing and project management
Understanding where the major pinch points are in bioanalytical assay development and validation has helped lexartys improve project management to meet aggressive submission timelines
General review of documents to ensure quality and accuracy
Review of scientific rationale
Review of bioanalytical strategy
Assessment of bioanalytical resourcing, and CRO oversight
Integration of bioanalytical, preclinical, and clinical data into regulatory process to support program submissions
