Analytical Development and Validation

Timely and comprehensive analytical development is key to the success of any project.

We can help you develop strategies to create and efficiently leverage the right analytical tools throughout the development cycle. We’ve helped with a variety of analytical projects including new technology evaluation, pre-formulation, method development, transfer and validation, stability programs, reference standard programs, and molecular characterization.

Method Development and Optimization

  • We use our considerable experience to solve clients’ analytical development issues. The solutions come in all forms, including
    • Researching solutions that others have published
    • Deriving solutions from data that your organization has already developed
    • Benchmarking your results with similar efforts we are familiar with
  • We can compose and/or review protocols and reports related to your method development efforts
  • We can provide statistical experimental design and data analysis
    • Example: statistical DOE for method robustness studies to identify critical parameters

Contract Lab Selection and Liaison

  • We use decision tools to help identify the best contract analytical lab for your particular project
  • We perform comprehensive and strategic coordination of all analytical and bioanalytical activities at your contract laboratories
  • We provide hands-on assistance during tech transfer and method implementation activities at your contract lab, including writing/reviewing SOP’s and methods for sample chain of custody, reviewing storage conditions and procedures, following up on pull dates and facilitating the release of your data

Method Transfer and Validation

Whether your quality control strategy utilizes in-house resources, your contract manufacturer, or a third party analytical testing laboratory, or all of the above, the effort to transfer and validate methods suitable for a commercial product is time consuming and management intensive. We can help! A partial list of analytical projects we have undertaken includes:

  • Development of strategy and approach to streamline method transfer or validation efforts
  • Validation of methods for product release, in-process controls, bioanalytical or biomarker methods, cleaning, and raw materials testing
  • Development, oversight, and review of documents related to the comparability and validation efforts, including:
    • Master Plans
    • Development Lab characterization protocols and reports
    • SOPs, batch records, and related GMP documents
  • Specification development
  • Risk assessments and gap analysis
  • Coordination of method transfer with process scale-up activities
  • Technical investigation of deviations, method failures, and out-of-specification results
  • Writing and review of related CMC sections for global regulatory submissions
  • Master planning, scheduling and tracking of validation efforts
  • Validation of related equipment, computer systems and other automated systems
  • Hands-on assistance during method transfer and validation activities

Product Characterization and Reference Standards

Understanding your product is of paramount importance. Regulators require it, investors demand it, and it can mean the world to your patients. Getting this testing right is critical throughout the development cycle. We have helped clients on a number of important projects, including:

  • Development, oversight, and review of protocols and assessments related to the product characterization efforts, including experimental design and data analysis
  • Development of strategy for identifying and producing appropriate reference standard
  • Development of strategies for long-term management of the reference standard or other critical reagents
  • Composing and reviewing protocols for characterizing the reference standard

Stability Program Management and Data Analysis

The stability program may be your most challenging analytical activity. The high volume of data (related to different samples of different ages stored under different conditions) can be difficult to manage and communicate. Very often, critical facts drop through the cracks and come back to haunt you during regulatory filings and inspections. On the other hand, good news is also lost that would benefit product placement and future stability efforts. We’ve helped clients navigate their stability data in a variety of ways, including:

  • Development, oversight, and review of protocols and assessments related to the stability testing required for meeting guidelines
    • Forced degradation and photostability
    • Long-term and accelerated stability
    • In-use stability
  • Statistical trending of stability data and setting of retest dates
  • Determination of stability indicating assays, and identification of assays that should not be used on stability
  • Tracking of purity and assay on stability, as well as identifying any impurities that may require future characterization

Stability Program Management and Data Analysis

  • Provide oversight for analytical support of CBE and SUPAC supplements.