Analytical Development and Validation

Our analytical professionals have extensive biotechnology industry experience from discovery through commercial stages.

RMC gives you technology experts who understand current analytical methodologies as well as global regulatory requirements and expectations specific to biotechnology products. Our analytical services include support for strategic planning, critical reagents and reference standards programs, method development/transfer/validation, product characterization and comparability, Quality Control, and stability.

Method Development and Optimization

We use our considerable experience to solve clients’ analytical development issues. The solutions come in all forms, including:

  • Researching literature or guidelines 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 can 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 or batches

Method Transfer and Validation

Whether your quality control strategy utilizes in-house resources, your contract manufacturer, 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 related analytical projects we have undertaken includes:

  • Development of strategy and approaches 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 method validation efforts, including:
    • Validation Master Plans
    • Development Lab characterization protocols and reports
    • SOPs, batch records, stability reports and related GMP documents
  • Specification Development
  • Risk assessments and gap analysis
  • Coordination of method transfer and related technology transfer activities
  • Technical investigation of deviations, method failures, and out-of-specification results
  • Writing and review of related CMC sections for global regulatory submissions
  • Validation of related equipment, computer systems and other automated systems

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
  • Characterization work related to product comparability after scale and process changes
    • Selection of appropriate comparability methods and techniques
    • Assessing the significance of differences that will be found
    • Designing comparison experiments to maximize insight into real differences vs method variability
  • Development of strategy for identifying and producing appropriate reference standard
    • Assignment of critical certification parameters such as strength and potency
    • Selection of appropriate presentation/configuration to maintain critical properties
    • Bridging between different batches of standard
  • Development of strategy for long-term management of the reference standard and 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 activity on stability, as well as identification of impurities that may require future characterization