Before formulation development, pre-formulation research is typically necessary to determine the optimal combination and ratio of raw materials and excipients to meet specific product requirements. As a pharmaceutical expert in therapeutic proteins and peptides, CD Formulation can design and explore the most suitable pre-preparation formulas for various protein and peptide drugs. Additionally, we conduct comprehensive evaluations of physical and chemical properties, identifying any potential issues or challenges that may arise during formulation development.

Why Conduct Pre-formulation Studies?

Pre-formulation studies represent a crucial stage in the development of any drug molecule, including proteins and peptides. These studies delve into the physical and chemical characteristics of drug molecules, encompassing solubility, stability, dissolution kinetics, morphology, crystal structure, surface properties, intermolecular interactions, etc. These properties not only influence therapeutic efficacy but also dictate the specifics of formulation development.

Pre-formulation studies for peptides and proteins are inherently complex compared to small molecule drugs. This complexity arises from the multiple sites within the structure of a peptide or protein that are susceptible to various physical instabilities (e.g., denaturation, precipitation) and chemical instabilities (e.g., oxidation, deamidation, beta-elimination). However, pre-formulation studies provide a comprehensive approach to understanding and optimizing the properties of protein and peptide molecules, ensuring their effectiveness and stability throughout dosage form development and pharmacological studies. Through pre-formulation research, potential issues can be identified and addressed, while improved designs can be proposed to enhance the performance and stability of drug molecules.

Explore Our Protein & Peptide Pre-formulation Services

At CD Formulation, for protein and peptide active pharmaceutical ingredients (APIs), our pre-formulation research includes screening to find optimal conditions supporting upstream and downstream processing and production, ensuring the quality and stability of the final product. Leveraging advanced technologies and methodologies, our team meticulously analyzes and evaluates protein and peptide APIs, considering factors such as stability, solubility and other characteristics. Through carefully designed experiments and testing, we deliver high-quality, reliable protein and peptide preparation products to our clients.

At this stage, we also offer the development of stability-indicating assays and the identification of some key excipients using systematic approaches such as Design of Experiments (DOE) or Empirical Phase Diagrams (EPD). We meticulously screen excipients and their ratios by detecting the impact of different stress conditions such as pH, temperature, freeze-thaw, drying, and purity on the preparation, thereby determining the most suitable conditions and processes for formulation.

We will continue to develop your lyophilized product if initial stability studies indicate that traditional liquid formulations don’t meet the desired target product characteristics established early in your project.

Furthermore, throughout pre-formulation studies, our dedicated team offers support in developing and optimizing relevant analytical methods for subsequent formulation development stages. Our pre-formulation research services include, but are not limited to:

Why Choose Us for Protein & Peptide Pre-Formulation Studies?

• Boasts a team of experts with robust backgrounds in pharmaceuticals, physics, and protein chemistry, specializing in protein and peptide pre-formulation research.
• Equipped with cutting-edge equipment and technology for comprehensive analysis of protein and peptide characterization, ensuring the acquisition of the most accurate and precise data.
• Offers a range of testing options tailored to accommodate the pre-development needs of various protein and peptide types, including monoclonal antibodies, recombinant proteins, therapeutic peptides, and more.
• Provides flexible trial designs and customized solutions.

Publication

Pre-formulation research involves characterizing the physical and chemical properties of therapeutic proteins and peptides, both in isolation and when combined with excipients. This process provides crucial data to support subsequent formulation development stages. CD Formulation is dedicated to aiding you in conducting pre-formulation research to bolster yourdrug development endeavors. Please don't hesitate to contact us if you are interested in our services.