Protein & Peptide Lyophilization Formulation Development

The development of stable lyophilized protein/peptide formulations requires maintaining the physical and biological integrity of the protein/peptide and improving the efficiency of the manufacturing process. CD Formulation has extensive expertise and success in processing protein and peptide lyophilized biologics, allowing develop robust quality formulations for you using different effective quality-by-design (QbD) tools according to ICH guidelines.

Lyophilization & Why Lyophilize Proteins/Peptides?

Lyophilization, also known as freeze-drying, is a process that involves freezing a substance and then removing the frozen water by sublimation, resulting in a dry product. Lyophilization is the preferred method for obtaining more stable products for sensitive drug molecules that are unstable in solution and prone to aggregation, degradation and other denaturation, such as proteins and peptides. Currently, this technology has been widely used in the pharmaceutical industry to develop protein/peptide freeze-dried formulations, which can be reconstituted with water or other suitable solvents for injection or oral administration.

Compared with traditional protein/peptide solutions, freeze-dried protein/peptide formulations have the following advantages:

• High stability.
• High bioavailability.
• Easy to prepare into the solid dosage form.
• Convenient storage and transportation.
• Long shelf life.

Explore Our Proteins & Peptides Lyophilization Formulation Development Services

Quality by design (QbD) is the preferred approach to formulation development, aiming to achieve robust, high-quality products and continuous improvement. At CD Formulation, our formulation scientists design and develop protein/peptide lyophilization formulations using the QbD approach with a focus on your target quality product profile (QTPP) custom study.

We consider multiple factors, including the selection of excipients and lyoprotectants, optimization of process parameters, and evaluation of product characteristics, to ensure that the quality of the final product meets your needs and expectations. Importantly, we can consider factors that may affect product quality in the early stages of formulation development in the QbD approach, thereby avoiding problems later and saving time and cost.

Fig. 1 Quality target product profile of freeze-dried products. (Pardeshi SR, et al., 2023)

To develop robust and economical lyophilized formulations and processes suitable for large-scale production, allowing easy switch from protein/peptide liquid formulations to protein/peptide lyophilized formulations. We implement a step-by-step development plan tailored to your product characteristics and development stage needs. We provide you with powerful single/combination services, including but not limited to:

• Stabilizer screening service.
• Freeze-dried protective agent screening service.
• Repeated freeze-thaw research service.
• Freeze-drying process development service.
• Freeze-drying process optimization service.
• Stability study service.
• Freeze-dried preparation analysis and testing service.
• Development and validation of freeze-dried product analysis methods.

Fig. 2 Protein/peptide lyophilized formulation development services. (CD Formulation)

General Workflow for Protein & Peptide Lyophilized Formulation Development

Preformulation Studies

The stage includes determining the appropriate protein/peptide liquid formulation composition. Such as pH, ionic strength, protein concentration, excipients, etc.; screening single or combined lyoprotectants, determining stability indicator methods, and analyzing and identifying possible degradation products.

Pre-lyophilization Studies

We use differential scanning calorimetry (DSC) and freeze-drying microscopy (FDM) to analyze the lyophilization characteristics of protein/peptide liquid formulations to obtain the maximum allowable critical formulation temperature, glass transition temperature (Tg') and collapse temperature (Tc) in the primary drying step, which is crucial because drying above this temperature will destroy the powder cake structure.

On this basis, we further explore different lyophilization conditions to prepare protein/peptide lyophilized formulations.

Lyophilized Formulations and Process Development

We use a large number of process analysis tools (PAT), collect samples in the process, and analyze them using a set of physical and chemical characterization methods suitable for lyophilized materials to develop and optimize processes that can be expanded and easily transferred between different lyophilizers.

Freeze-drying Process Optimization

Our scientists conduct comprehensive tests on protein/peptide freeze-dried preparations, including crystallinity, powder morphology, porosity, specific surface area, etc., to further explore the impact of process parameters on product quality, so as to reasonably adjust and optimize the freeze-drying process.

Characterization of Freeze-dried Finished Products

We conduct comprehensive physical and chemical characterization of freeze-dried products and place them under different stress conditions, such as temperature, humidity, and light, to conduct stability studies to obtain key information about the production and storage of protein/peptide freeze-dried products, achieving smooth and efficient process transfer.

Fig. 3 Freeze-drying process flow chart. (CD Formulation)

Development of Downstream Protein/peptide Delivery Systems

If necessary, our scientists incorporate different types of excipients or carriers such as liposomes, polymer microspheres, etc. into freeze-dried products according to your clinical application needs and administration methods to develop different delivery products, such as oral freeze-dried tablets, freeze-dried nanoformulations, freeze-dried injections, etc.

Why Choose Us for Protein & Peptide Lyophilization Formulation Development?

• Our experienced team of scientists and formulators have extensive experience and expertise in protein and peptide lyophilization formulation development.
• We are equipped with state-of-the-art facilities and technologies, capable of processing a wide range of proteins and peptides, such as monoclonal antibodies, recombinant proteins, ADCs, etc.
• We have hundreds of successful experiences in developing a variety of protein and peptide lyophilization formulations and can customize our approach to your product-specific needs.
• We provide seamless support from formulation research to market.
• We are at the forefront of new lyophilization technology, committed to process innovation and efficiency improvement.
• We provide flexible experimental design and testing options that can meet any customer's specific needs.

Publication

CD Formulation is always at the forefront of protein and peptide formulation development, dedicated to providing unparalleled protein/peptide lyophilization formulation development services to the pharmaceutical industry. Our formulation scientists combine proven lyophilization methods with the latest protein and peptide science knowledge to create formulations that optimize stability, appearance, and manufacturability. Please feel free to contact us if you are interested in our services. We will provide you with the best solutions and support.

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.