Dose Formulation Analysis
KCAS Bio excels in drug quantitation and method validation of small molecules, peptides, proteins, siRNA, antibodies, and antibody-drug conjugates in all vehicles. We are skilled in assessing formulation stability and compatibility, supporting your formulation and toxicology studies. Additionally, KCAS Bio offers Certificate of Analysis (CoA) and Certificate of Testing (CoT) services.
Rapid delivery dose formulation analysis
KCAS Bio has experience in all aspects of dose formulation analysis including confirmation of concentrations in your dosing formulation, solution uniformity, and stability.
KCAS Bio scientific experts develop methods that achieve your study requirements. Our team rapidly develops and validates analytical methods following the appropriate regulations for your studies.
Core capabilities at a glance:
• Formulation analysis, concentration verification, and homogeneity testing.
• Stability and purity of drug and formulation at study concentrations.
• Compatibility of the drug with vehicle excipients and containers.
Dose Formulation Technical Capabilities
Following GLP FDA 21CFR58 OECD, KCAS Bio 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.
KCAS Bio complies with the US Food and Drug Administration (FDA), Good Laboratory Practice (GLP), the Organization for Economic Cooperation and Development (OECD), and the Japanese Ministry of Health and Labor and Welfare (MHLW).
Key Differentiating Features
- Method assessments for proof of concept
- Professional eCTD, FDA-ready GLP study reports
- Homogeneity, compatibility, and in-use stability studies
- Certificate of testing preclinical analysis for test and control articles
- 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
Related dose formulation services
We can help you formulate a plan
Dose Formulation Analysis is an essential step in regulated nonclinical studies. Robust analytical methods, rapid turnaround, and efficient communication help deliver your GLP studies' dose formulation analysis results on time.
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Dose Formulation Analysis (DFA) is a critical component in regulated nonclinical studies, ensuring accurate dosing and supporting toxicokinetic assessments. At KCAS Bio, we specialize in providing comprehensive DFA services. Below are the top frequently asked questions about Dose Formulation Analysis and our services: 1. What is Dose Formulation Analysis, and…
Blogs
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…
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We prepare and adapt our services based on a deep understanding of your drug development ambitions and wider business objectives.