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Creative Biolabs: Expert in NHP-based method development and validation!

Creative Biolabs is a global method development and validation service supplier and has accumulated comprehensive experience in the drug development and manufacturing area. Our dedicated team has accumulated comprehensive knowledge of method feasibility evaluation and can give more valuable suggestions for your project. Whether for small or large molecules, Creative Biolabs can make good use of the latest techniques to develop robust methods.

What We Can Provide

At Creative Biolabs, we integrate extensive expertise and state-of-the-art equipment to design, optimize, evaluate, and validate testing methods with strong applicability and stability. When it comes to drug development, these methods will shorten your experimental period and help you predict the efficacy and safety of your candidate drug more accurately. We are devoted to offering one-stop services from idea to execution, which can avoid a lot of unnecessary time spent in exploratory experiments and allow you to focus more on other important research. All method development and validation studies are conducted adhering to regulatory requirements and can ensure the research results meet the highest standards.

• Method Development Service

Method development is a very challenging task in most cases and relies heavily on the operation skills and practical experience of personnel. Creative Biolabs has established a suite of systematic procedures for developing route or custom assay methods for multiple therapeutic fields, including metabolic disorders, CNS diseases, inflammation/immunology, cardiovascular diseases, and so forth. Particularly, we are capable of collecting a large range of primate biospecimens, which can be used for the development of various methods for drugs, APIs, and excipients.

• Method Validation Service

The accomplishment of a new assay method development doesn't mean the end of research. There are a series of validation procedures that need to be executed one by one. We have designed a standard approach to evaluate and validate the performance of the established method. Specific validation indicators contain specificity, limits of detection and quantification, linearity, accuracy, precision, and robustness. At present, our method development and validation services are mainly launched for pharmaceuticals. If you have some special needs, welcome to get in touch with us to talk about the feasibility of implementation.

Why Partner with Creative Biolabs

As a reputable NHP product and service provider, Creative Biolabs has a large amount of available monkey sample resources to support your method development and validation needs. Choose Creative Biolabs as your partner and you can rest assured of the efficiency and quality of result delivery. Whether you have already some preliminary ideas or not, welcome to contact us anytime to get more feasible proposals.

Published Data

The article focuses on the development and validation of a novel method for the quantitation of Cp40 in human and non-human primate (NHP) plasma. Cp40 is a cyclic 14-amino acid peptide, a compstatin analog, known for its strong affinity to complement component C3 and its potential in treating complement-mediated diseases.

The study highlights the successful application of ultra-high performance liquid chromatography electrospray mass spectrometry (UPLC-ESI-MS) combined with solid-phase extraction for accurate and precise quantification of Cp40. This method was validated with high recovery rates and minor matrix effects, demonstrating robustness and sensitivity. Notably, the method showed excellent linearity across a range of concentrations in both human and NHP plasma.

The significance of using NHPs in this research is underscored by the close physiological similarity between NHPs and humans, making them essential for pharmacokinetic and pharmacodynamic studies. The study details a pharmacokinetic analysis involving cynomolgus monkeys, showcasing how the optimized method can track Cp40 levels effectively in NHP plasma. This contributes significantly to understanding the drug's behavior and efficacy in a model closely representing human physiology, underlining the importance of NHPs in biomedical research.

Fig. 1. Standard curves of Cp40 in human (A) and NHP (B) naïve plasma. The x-axis displays the spiked Cp40 concentration in plasma, and the y-axis corresponds to the ratio of the Cp40 peak area (counts) divided by the respective IS peak area (counts).

Fig. 2. Quantitation of Cp40 in plasma of a male (A) and a female (B) cynomolgus monkey. Graphs represent a linear plot of Cp40 concentration over time, measured by UPLC-ESI-MS: A single intravenous bolus injection of 2 mg/kg was followed 2 h later by the first subcutaneous injection (1 mg/kg) at time point 0; subcutaneous injections continued every 12 h for 6 days. The C3 concentration, as determined by nephelometry, is depicted as a dashed line. Concentrations are expressed in μM in order to allow us to assess the drug-to-target ratio. Injection time points are shown in gray and black arrows at the bottom of the graphs.

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