Peptide & Protein Lyophilized Formulation Development
InquiryCD Formulation has a team of pharmaceutical scientists seeking to enable innovation by optimizing formulations for novel biologics. We deeply understand the advantages freeze-drying offers fragile molecular classes like peptides and proteins. Our methodical approach to excipient selection and cycle optimization quickly made us leaders in lyophilized formulations for early phase development.
Benefits of Lyophilizing Proteins and Peptides
- Maintain Biological Activity
During the freeze-drying process, the structure of peptides and proteins is kept intact, thereby maintaining their biological activity. This is important for biological agents that need to remain active, such as enzymes, hormones, antibodies, etc.
Lyophilized formulations remain stable without added preservatives and can be stored for longer periods of time. Due to the removal of moisture, microbial growth and reproduction are inhibited, thereby extending the shelf life of the product.
Since the volume of lyophilized preparations is smaller than that of liquid preparations, they can be transported more conveniently, especially for preparations that require cold chain transportation.
What Can We Do for Peptide & Protein Lyophilized Formulation Development?
- Preparation of Peptides and Proteins
You decide whether to have us prepare your peptide and protein samples. At CD Formulation, we can prepare proteins and peptides through chemical synthesis, microbial fermentation, genetic engineering and other technical means.
Based on the properties and targets of peptides and proteins, we will design appropriate lyophilized formulations for customers, including the selection and determination of drug carriers, protective agents, buffers, co-solvents and other ingredients.
- Lyophilized Formulation Processing
According to the preparation formula, the polypeptides and proteins are mixed with other excipients, dissolved, emulsified and lyophilized to prepare a peptide and protein lyophilized formulation that meets certain quality standards.
- Quality Analysis of Lyophilized Formulation
At CD Formulations, quality assurance is paramount. Our analytical services provide thorough chemical and biological assessments. This can include identifying formulation ingredients and measuring bioactivity levels.
Lyophilized Formulation Excipients You Can Choose
| Excipient Types |
Characteristics and Applications |
| Buffers |
Buffers like phosphate and histidine maintain an ideal pH for protein stability and solubility. |
| Bulking agents |
Bulking agents like mannitol and glycine form the amorphous, freeze-dried solid matrix. They can enhance the structure of lyophilized formulation. |
| Stabilizers |
Stabilizers such as sucrose, trehalose, and glycerol provide thermodynamic and structural stability during processing stresses. |
| Surfactants |
Surfactants like polysorbate inhibit protein aggregation at the ice-water interfaces during freezing. |
| Amino acids |
Amino acids like arginine that suppress reactions and enhance solubility and folding. |
| Salts |
Salts and polyols modulate tonicity, osmolality, and crystallization behavior. |
How Do We Develop Peptide & Protein Lyophilized Formulation?
-
Excipient Screening
A matrix of potential stabilizers and bulking agents is assembled for testing.
-
Prototype Formulation
Various formulations are prepared based on the excipient screen results and initial analytical data.
-
Freeze-Thaw Studies
Formulations undergo freeze-thaw cycling and analysis to assess preliminary stability.
-
Lyophilization Cycle Development
The freeze-drying process is optimized for product cake quality using DOE methods.
-
Accelerated Stability Studies
Lyophilized prototypes are placed on initial stability at elevated temperatures to quickly identify promising leads.
-
Characterization
Leading candidates undergo in-depth physical, chemical and functional testing to confirm optimal stability.
Advantages of Our Lyophilized Formulation Development Services
- Peptide and protein formulation experts who become an extension of your team, providing seamless support from research to market.
- Methodical development approach based on statistically designed experiments, not trial-and-error guesswork.
- Superior manufacturing capabilities and capacity, validated for the most complex protein formulations.
- Technical leadership in novel drying technologies for process innovation and efficiency.
- Client-focused project management and communication ensure transparency at each development stage.
At CD Formulation, we combine proven lyophilization methods with customization to create formulations that optimize stability, presentation and manufacturability. Our experts are passionate about enabling your product's success. We look forward to partnering with you in advancing biologics through cutting-edge formulation technologies. Please contact us!
Related Services
