Method Development and Validation

Method Development and Validation

Scientific oversight of all method-related activities

Method development, validation and transfer are essential but often overlooked elements of traditional pharmaceutical and biological development.

BioData Solutions can help with all stages of method development and validation for both large and small molecule projects. At the initial stages, our team can assist you in choosing a platform as well as generation of critical reagents and reference standards. We can oversee method development, provide guidance and troubleshooting for both internal labs and work outsourced to CROs. We can assist in defining experiments needed for “fit-for-purpose” methods according to your experimental goals and stage of development.

We also provide oversite for assays moving from development mode through validation and sample analysis (production mode). We can ensure methods are up to date with the latest regulatory guidance and troubleshoot problems encountered during validation or production. We can also help transition assays from CLIA laboratories to GLP laboratories according to FDA guidance. Afterwards, we can assist in reviewing or writing reports to ensure regulatory compliance.

Our team has a vast range of experience, and we will pair you with the consultant most suitable for your stage of development and asset time.

As a team, we have experience guiding assets from early research through clinical trials and registration for the following types of molecules:

  • Small molecules (New Chemical Entities)
  • Large Molecules (Biologics)
    • Antibodies
    • Proteins
    • Antibody-Drug Conjugates (ADCs)
    • Fusion Proteins
    • Bi-functional Proteins/Antibodies
  • Cell and Gene Therapies
    • Whole-cell therapies
    • Viral and non-viral gene therapy products
    • Gene editing products
  • Biomarkers
  • Oligonucleotides

In addition to our consulting services, we also offer auditing software for small and large molecule PK data for method validation and sample analysis. For more information, please read more about Red Thread

Services offered include,
but are not limited to:

Whether your program involves small molecule, large molecule, biomarkers, or cell and therapy products, our services help ensure regulatory compliance.

  • Assay selection
  • Recommend and collaborate with vendors for the production of critical reagents and reference standards
  • Ad-hoc bioanalytical expertise for troubleshooting, platform or program support to internal labs or CROs during method development
  • Oversee fit-for-purpose qualifications that are regulatory compliant and appropriate for the development stage of the molecule
  • Review method validation plans and oversee validations to ensure regulatory compliance
  • Continual review of data in real time to meet timelines

In partnership with PPD, we explored the feasibility of single-well analysis over duplicate-well analysis. The study with less variable populations yielded equivalent results for singlet analysis as for duplicate-well analysis for cut point determination.

A poster publication in partnership with PPD

Contact us today and let us know what challenges you are facing.