Robust analytical methods are required to ensure products are safe and effective for clinical use. Analytical methods are used throughout the product lifecycle to guide early R&D decisions through to lot releases of GMP material for clinical supply chain.

Developing reliable methods early in the campaign ensures that product specifications are established to guide late-stage manufacturing efforts and minimize corrective actions of large-scale batches.

Analytical development de-risks Critical Quality Attributes (CQAs) through the development process. We develop a library of assays specific to the product, therby setting product specifications for CQAs that balance safety and production standards. After the analytical methods are developed and qualified according to regulatory guidance, SOPs for each method are written to enable streamlined processes in the production process. 

  • Critical Quality Attribute (CQA)
  • Risk Assessment
  • Method Development and Qualification
  • Validation of Protocols and Reports
  • Hands-On Lab Support
  • Expert Review
  • SOPs
  • Specification Development
  • Analytical Method Transfer
  • Third Party Contract Research Laboratory Support
  • Product Characterization

TKD Solutions has a team of skilled has skilled analysts with experience in analytical method development and qualification for gene therapies, biologics, and cell therapies.

We further recommend suitable assays to test your modality for for sterility, bioburden, and adventitious agents. We can advise on assay development, qualification, and lot release requirements pertaining to safety, identity, purity, potency, charge, glycosylation and impurities.

TKD can also guide analytical development for cellular phenotyping, vector characterization, efficacy and toxicity. We work with your team to de-risk CQAs and set specifications that will optimize production quality and throughput.

By developing methods based on product specifications and regulatory requirements specific to your program we help eliminate late-stage changes to your process.

See how we can cost-effectively develop the right analytical program for your unique therapeutic.

Nonclinical / Early Phase Development Process Development Regulatory Affairs Cross-Departmental Support Analytical Development Project Management Manufacturing Science & Technology Nonclinical / Early Phase Development Process Development Manufacturing Science & Technology Analytical Development Project Management Regulatory Affairs Cross-Departmental Support