Dose Formulation Analysis is an essential step in regulated nonclinical studies. Robust analytical methods, rapid turnaround, and efficient communication helps ensure the dose form results for your GLP studies are delivered on time.
At KCAS Bio, our scientific expertise allows us to develop methods that achieve your study requirements. Our experts understand the different complexities involved in dose formulation vehicles. This means we develop validated methods quickly, using the appropriate analytical tools for your studies.
A solid, semisolid, and liquid formulation of pharmaceuticals is a key step in the drug development and preclinical process. Methods are developed to confirm APIs in the dosing formulation, formulation homogeneity, and stability. In addition, if stereoisomers are part of the formulation, regulatory agencies now require each enantiomer to be separated and studied individually.
KCAS Bio delivers high-quality data on time to our customers, helping them in their drug development needs.
KCAS Bio has significant experience in all aspects of dose formulation analysis. Methods utilizing UV/Vis or Fluorescence detectors, whichever is appropriate for your protein or small molecule. In addition, KCAS Bio has substantial infrastructure and decades of expertise in qualitative and quantitative separations utilizing HPLC mass spectrometry detection of peptide drugs. Solid, semisolid, and liquid formulations of pharmaceutical leads are one key step in drug development.
Methods are optimized to confirm the API concentration in your dosing formulation, solution uniformity, and stability.
Technical Capabilities
Following GLP FDA 21CFR58 OECD, KCAS develops and validates our Dose Form Testing Methods (UHPLC-UV, UHPLC-FLD, or LC-MS/MS) for precision, accuracy, linearity, range, specificity, and limit of quantitation. We follow dose formulation validation guidelines from AAPS. After method development and validation of test methods for each vehicle, we perform GLP formulation stability studies in parallel with Dose Formulation Studies. Formulation Stability Studies cover each Test Method across all Dose Form Studies. Using the lowest and highest study formulation concentrations, we assess the longest storage time across studies and all formulation storage / shipping temperatures.
Key KCAS DFA Differentiators
- Fast method transfer, development, and GLP validation
- Method assessments for proof of concept
- GLP formulation stability covering all your dose form studies
- Professional eCTD FDA-ready GLP study reports
- Homogeneity, compatibility, and in-use stability studies
- Single-contact project management
- Certificate of testing preclinical analysis for test and control articles
- State-of-the-art 70,0000 sq ft analytical laboratory
- Method Development with limited API during the CMC stage
- GLP analysis of dose form suspensions, solutions, capsules, or feed
- Quantitative analysis of challenging formulations using RP-UHPLC-UV, SEC-HPLC-UV, LC-MS/MS, NanoDrop
- Expertise with difficult formulations of proteins, peptides, biologics, and polymers
Don’t let rework slow down your IND programs.
Partner with the KCAS Bio team to manage your small and large-molecule dose formulation analyses. Our expert team delivers validated dose formulation stability, homogeneity, purity, and content analyses, whether SEC, HPLC-UV, LC-MS, GLP or non-GLP.
Visit our facility and take your GLP dose formulation research to the next level.
If you have any questions about this or any other services from KCAS Bio, we invite you to reach out using the form below!