Evaluating the critical quality attributes (CQAs) of nanoformulations, such as physicochemical properties, composition, encapsulation efficiency, and drug release from nanoformulations, as well as establishing drug product specifications, is essential for developing protein and peptide nano-delivery systems. CD Formulation conducts comprehensive characterization and analysis of protein or peptide nanoformulations in accordance with FDA manufacturing and Chemical manufacture and control (CMC) guidelines, including physicochemical properties, composition, encapsulation efficiency, in vitro release of drug products, and stability testing to ensure the consistency and stability of your product, reduce the risk of adverse reactions, and improve the safety and efficacy of your product.

Why Conduct Nanoparticle Characterization for Proteins & Peptides Formulation?

Protein/peptide nanoformulations are products that use nanotechnology to encapsulate therapeutic proteins/peptides in appropriate nanoparticle carriers to form nanoscale particles or colloids. Compared with traditional preparations, protein/peptide nanoformulations have smaller particle sizes and larger specific surface areas, which can improve the stability, biological activity and efficacy of proteins, and can also improve the biodistribution and tissue permeability of proteins and peptides.

Nanoparticle characterization for roteins/peptides formulation provides a powerful analytical tool for in-depth understanding of important information such as their physicochemical properties, biological activity, stability, nanoscale structure, etc., thereby providing basic data and reference basis for their application in drug delivery, bioimaging, biosensing and other fields. Characterizing protein or peptide nanoformulations, key factors such as efficacy, toxicity and biocompatibility can be evaluated, providing effective direction and basis for further optimizing formulation design and improving formulation performance.

Explore Our Nanoparticle Characterization for Proteins & Peptides Formulation Services

Reliable and accurate nanoparticle characterization and analysis are essential to support the new drug application (NDA) and abbreviated new drug application (ANDA) of protein or peptide nanomedicines. Our analytical laboratory is equipped with advanced equipment to support the development of various nanoformulations such as liposomes, microspheres, nanoparticles, and hydrogels, and perform a full range of characterization services for protein or peptide nanoformulations in accordance with FDA and BLA CMC guidance requirements.

Our nanoparticle characterization services for proteins and peptides formulation include but are not limited:

Fig.1 Proteins and peptides nanoformulation characterization. (CD Formulation)

General Characterization of Protein or Peptide Nanoformulations

General characterization of nanoparticles involves the physicochemical parameters identified as CQAs during product formulation development and batch-release testing, such as surface morphology, particle size, size distribution, zeta potential, crystal structure, etc. Our nanoformulation scientists use a range of advanced techniques and equipment to obtain key information about protein or peptide nanoparticles, which is important for evaluating the stability, biocompatibility, drug release performance, etc., of nanoparticles. Commonly used technical equipment includes:

• Morphology characterization: electron microscope (SEM), transmission electron microscope (TEM).
• Particle size analysis: dynamic light scattering (DLS), laser particle size analyzer.
• Surface properties: surface plasmon resonance (SPR), X-ray photoelectron spectroscopy (XPS).
• Crystallographic properties: X-ray diffraction (XRD).
• Optical properties: UV-visible absorption spectrum, fluorescence spectrum.

Protein or Peptide Nanoformulations Encapsulation Efficiency and Drug Loading Assays

Protein or peptide nanoformulation encapsulation efficiency and drug loading assays involve evaluating the amount of drug contained within the formulation compared to the total amount of drug. We are skilled in using a variety of analytical techniques to determine the ability of a protein or peptide to be released from a specific nanoformulation under specific conditions. Our team of experts utilizes a range of analytical methods to better understand the integrity of the nanoformulation, such as drug encapsulation efficiency, drug loading, and drug release rates, these changes occur in response to pH, temperature, excipient addition, changes in salt concentration, and/or interactions with the filtration process or manufacturing surface components.

Stability Testing of Protein or Peptide Nanoformulations

ICH stability studies are at the heart of any drug formulation development program. For protein or peptide nanoformulations, we can perform comprehensive stability studies and stress testing (after exposure to light, pH, and oxygen) to evaluate the degradation of the protein or peptide under different conditions. We can use this degradation profile to establish stability-indicating analytical methods, including physicochemical properties such as particle size and particle size distribution. This information helps determine appropriate storage conditions and retest periods. Our stability testing includes:

• ICH stability testing analytical method development and validation.
• Long-term stability testing
• Intermediate stability test.
• Accelerated stability testing.
• In-use stability testing.
• Forced degradation testing.

Protein or Peptide Nanoformulations Quality Control Testing

Regulatory requirements for protein or peptide nanoformulation product specifications include a range of parameters, including analysis of all components of the drug product such as lipids, free drugs, encapsulated drugs, and process impurities. Our protein team provides analysis to help you solve any problems that may arise, including:

• Total protein or peptide drug content determination.
• Residual solvent determination.
• Process-related impurities analysis.
• Extractables and leachables analysis.
• Degradation product analysis.
• In vitro release determination of protein or peptide drug.

Biocompatibility Assessment of Protein or Peptide Nanoformulations

Before applying protein or peptide nanoformulations in clinical practice, the toxicity and biocompatibility of nanoparticles must be carefully evaluated to understand the physicochemical properties that lead to adverse biological reactions. At CD Formulation, our scientists use the following three methods to obtain information on the toxicity and biocompatibility of protein or peptide nanoformulations and provide reliable data support for clinical research.

1) Blood cell aggregation and hemolysis studies and coagulation behavior experiments to evaluate the blood compatibility of nanoparticles under in vitro conditions.

2) Appropriate animal models for evaluating the tissue compatibility of nanoparticles under in vivo conditions.

3) Cellular experiments for evaluating the cell uptake capacity and cytotoxicity of nanoparticles under in vitro conditions.

When evaluating the toxicity and biocompatibility of nanoparticles, we also consider the effects of surface modification, particle size, shape, and other factors on their biological activity. We carefully design and regulate nanoparticles' physicochemical properties, effectively reducing their toxicity to organisms and improving their biocompatibility, helping you better realize the clinical application of protein or peptide nanoformulations.

Integrated Expertise in Protein or Peptide Nanodelivery Systems Development and Characterization

• Our scientists have extensive experience with a variety of protein or peptide nano-delivery systems and analyses, including liposomes, microspheres, hydrogels, polymers, etc.
• We provide important data for your protein or peptide nano-formulation products that meet regulatory requirements (GLP/cGMP).
• We have expertise in study design (such as stability studies and time point testing) and the development and validation of methods customized for the characteristics of your protein or peptide nano-formulation products.
• The data we generate can be used to help you establish drug specifications, or support regulatory submissions such as IND/NDA/ANDA or BLA, or support your ongoing quality control.

Why Choose Us for Proteins and Peptides Nanoformulation Characterization?

• Our team of scientists have extensive experience in the field of nanotechnology and drug delivery, allowing us to effectively analyze and characterize a wide range of protein and peptide formulations.
• We offer a comprehensive range of characterization services, including size measurement, morphology analysis, stability assessment, and more, providing a complete picture of your nanoformulation.
• We understand that each protein and peptide formulation is unique,  tailoring our characterization methods to suit the specific needs of each project.
• We utilize state-of-the-art instrumentation and techniques for the characterization of proteins and peptides nanoformulations, ensuring accurate and reliable results.
• We work closely with our clients throughout the services process, providing guidance and support to help you achieve your research and development goals.

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Thanks to state-of-the-art analytical equipment and professional knowledge, CD Formulation is dedicated to providing unparalleled protein/peptide nanoformulation characterization services to the pharmaceutical industry. Please feel free to contact us if you are interested in our services. We will provide you with the best solutions and support.