Proteins & Peptides Druggability Assessment

Drugability assessment is the evaluation of the drug-like properties of lead drug candidates at an early stage for their potential to be successfully developed into stable, manufacturable, safe, and effective drug products. CD Formulation provides protein/peptide drugability assessment services, such as post-translational modifications, molecular stability, and physicochemical properties, to help you quickly narrow the screening range of candidate molecules in the early stages of therapeutic protein and peptide development, screen out the most active and most suitable candidate molecules for drug development, reduce the risk of late-stage development, and help the success of the project.

Drugability & Why Do You Conduct Drugability Assessment?

Drugability refers to the characteristics of a compound that has the potential to be developed into a drug that has undergone preliminary pharmacodynamic studies, early evaluation of pharmacokinetic properties, and safety.

Drugability assessment is the process of evaluating the pharmacokinetic, pharmacodynamic, and physicochemical properties of a drug to determine its potential for success in the development and commercialization process. Drugability assessment can:

Fig. 1 Advantages of drugability assessment. (CD Formulation)

• Predicting Pharmacokinetics: Drugability assessment helps in predicting how a drug will be absorbed, distributed, metabolized, and excreted in the body. This information is critical for determining the appropriate dosing regimen and ensuring that the drug reaches its target site at therapeutic levels.
• Assessing Pharmacodynamics: Drugability assessment also evaluates how a drug interacts with its target receptor or enzyme and how effectively it produces its desired therapeutic effects. This information is essential for determining the drug's efficacy and potential side effects.
• Identifying Potential Drug-Drug Interactions: Drugability assessment helps in identifying potential interactions between the drug under development and other medications that a patient may be taking. This information is crucial for ensuring the safety and efficacy of the drug.
• Optimizing Formulation: Drugability assessment can help in optimizing the formulation of a drug to improve its bioavailability, stability, and other critical properties. This can lead to a more effective and marketable product.
• Predicting Toxicity: Drugability assessment also includes evaluating the potential toxicity of a drug and determining the safety margin between the therapeutic dose and the dose that may cause harm. This information is essential for protecting patient safety during clinical trials and after commercialization.

Explore Our Proteins & Peptides Druggability Assessment Services

At CD Formulation, we perform a range of rapid and predictive tests to assess the druggability of therapeutic proteins and peptides.

Druggability assessments include in silico analysis as well as a range of in vitro assays of drug candidates to provide information on integrity, purity, aggregation, thermal stability, charge heterogeneity, glycosylation, polyreactivity, potency, stability at low pH and accelerated storage conditions, as well as potential PK/PD characteristics.

Our scientists provide the necessary data for candidate protein or peptide screening to help identify candidate compounds with good product quality, stability, and manufacturing performance, and reduce the risk during CMC process development.

Our typical protein/peptide druggability assessments include:

• Analysis of protein/peptide biophysical properties by in vitro assays, assessment of thermal stability, high concentration solubility, and viscosity for preferred physicochemical properties.
• High purity by capillary electrophoresis.
• Prediction of aggregation behavior by size exclusion chromatography.
• Prediction of high-risk post-translational modifications by protein sequence analysis, identifying process risks such as expression level, aggregation tendency, etc.
• Analysis of protein biophysical properties, assessment of thermal stability, high concentration solubility, and viscosity.
• Predict protein stability under different extreme conditions through rapid short-term stability studies.

Fig. 2 Protein/peptide druggability assessment process. (CD Formulation)

Our Proteins & Peptides Formulation Feasibility Assessment

In addition to drugability assessment, we also provide protein/peptide formulation feasibility assessment services for your target product based on obtaining the ideal therapeutic protein or peptide, covering:

• Protein/peptide solubility and viscosity assessment.
• Preliminary formulation screening (buffer/pH, sugars, salts, surfactants, etc.).
• Evaluation of formulation development concentration (high, low concentration) and dosage form (liquid or lyophilized).
• Formulation stability assessment.

Applications

CD Formulation can provide professional biopharmaceutical drugability assessment services. In the early stages of protein and peptide drug discovery, it can provide drugability assessment for candidate protein/peptide molecules to assess the risk of potential production or clinical failure. It can:

• Provides information for subsequent CMC development (such as cell culture parameters, purification difficulty, quality attributes, etc.).
• Provides preferred molecules, which is the practice and application of QbD.
• Prompts development risks and estimates the cost and cycle of CMC investment.

Why Choose Us for Proteins & Peptides Druggability Assessment?

• We have extensive expertise and experience in performing therapeutic protein/peptide drugability assessment and protein/peptide formulation feasibility analysis.
• We provide a variety of protein/peptide drugability assessment services, including post-translational modification analysis, thermal stability analysis, purity analysis, particle analysis, aggregation analysis, etc.
• Our laboratories are equipped with state-of-the-art instruments for protein/peptide characterization.
• We provide flexible experimental design and testing options to meet the specific needs of any customer.
• Fast and efficient services ensure that our customers' projects are delivered on time.

Publication

Protein/peptide druggability assessment as early as possible in the preclinical development stage can eliminate drug candidates that do not have good developability characteristics. CD Formulation understands the importance of protein and peptide druggability assessment. Please feel free to contact us if you are interested in our services. We will provide you with the most professional advice and support to ensure the smooth launch and implementation of your project.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.