Proteins & Peptides Spray Drying Formulation Development

Spray drying technology makes it possible to create advanced protein/peptide biologics, such as high-concentration protein/peptide suspensions, protein/peptide pulmonary inhalation formulations, and protein/peptide implants. With the most advanced spray drying technology, CD Formulation has extensive experience in processing a variety of biologics, including monoclonal antibodies, recombinant proteins, therapeutic peptides, etc., to support your protein/peptide biologics spray drying formulation development and particle design, improving product stability and seamlessly integrate into advanced drug delivery systems.

Protein/Peptide Formulation & Spray Drying Technology

The physicochemical instability of proteins and peptides during processing and storage is a major obstacle to their drug development and application. Protein/peptide biologics are usually prepared in solid dosage forms because higher stability can be achieved in a solid than in a liquid state.

Spray drying technology is one of the most common methods to increase the stability of proteins and peptides. This technology is a faster and more economical single-step drying method that can be designed as a continuous drying process. It can control the particle size and morphology of the dried powder by changing process parameters and formulation factors. In addition, the application of nano spray dryers can also produce nano-scale powders, improve the stability and therapeutic potential of proteins/peptides, and make them more effective and less toxic.

Explore Our Proteins & Peptides Spray Drying Formulation Development Services

Successful development of protein/peptide spray-dried formulations requires overcoming the challenges of the spray-drying process on protein/peptide stability. A stable protein/peptide formulation should have low water content (protein stability is inversely proportional to water activity), be able to be reconstituted quickly (rapid and complete reconstitution is usually achieved through a larger powder surface area), and have an optimized process or excipients to maintain the physical and chemical stability of the protein).

CD Formulation masters the most advanced spray-drying technology and can fully design and develop powerful protein/peptide spray-dried powders. These solid-state formulations can significantly improve the stability of your protein/peptide products and enable alternative routes of administration.

Fig.1 Requirements for successful spray dried biologic formulations. (Donthi MR, et al., 2023)

We comprehensively take into account the unique requirements of your target products and intentionally design these powders/particles to develop advanced downstream drug delivery systems, including inhalable powders, injectable suspensions, and long-acting implants. In addition, our experienced team of scientists can also apply nano spray dryers to prepare nano-scale protein/peptide spray-dried powders for targeted delivery.

Our scientists combine expertise in formulation and process development with proven capabilities in spray drying to provide you with unparalleled protein/peptide spray-dried powder development services and support you in the following aspects.

• Solid state characterization.
• Protein/peptide spray drying formulation analytical testing services (solubility testing, supersaturation studies, miscibility assessment, stability/stress studies).
• Spray-drying particle/powder design.
• Protein formulation development and spray drying.
• Peptide formulation development and spray drying.
• High-concentration injectable protein suspension development.
• Spray drying oral delivery system development for localized targeted delivery to the gastrointestinal tract.
• Spray-drying pulmonary inhalation product development.
• Spray-drying nasal delivery product development.
• Clinical and small-scale commercial cGMP spray drying.
• Seamless transfer of spray drying processes.

General Workflow for Proteins & Peptides Spray Drying Formulation Development

CD Formulation is an expert in spray formulation and process development. Our deep scientific knowledge, formulation and dosage form experience, and technical expertise form the cornerstone of our leadership in protein/peptide spray drying formulations. Our scientists systematically and comprehensively deploy advanced technologies and process strategies to design innovative spray formulations to ensure the successful formulation of proteins and peptides.

• Formulation design: involves screening excipients, natural sugars, amino acids, and surfactants to stabilize protein/peptide solutions and avoid aggregation/inactivation caused by thermal stress during the subsequent spray drying stage.
• Spray drying process development and optimization: involves optimizing parameters such as drying temperature, atomization pressure, and feed rate to achieve the desired particle size, morphology, and drug loading.

Fig.2 Schematic representation of spray drying process flow. (Donthi MR, et al., 2023)

• Microparticle/nanoparticle characterization: involves characterizing the physicochemical properties of spray-dried powders/particles using a range of analytical techniques, including particle size, particle size distribution, moisture content, charge, encapsulation efficiency, etc.

Fig.3 Characterization of protein/peptide spray drying microparticle/nanoparticle.(CD Formulation)

• Stability study: involves evaluating the changes of protein/peptide spray-dried preparations under different stress conditions (temperature, humidity, light, oxidation, and mechanical pressure) to guide the formulation design and process optimization of the preparations and ensure their reliability and consistency during use.
• Downstream delivery system development: involves designing and developing different delivery routes of spray-dried powders/particles, such as pulmonary inhalation products, nasal delivery products, and protein/peptide suspensions, etc., to achieve more effective drug delivery and absorption, and ensure that the stability and biological activity of the drug is not affected during the delivery process.

Why Choose Us for Proteins & Peptides Spray Drying Formulation Development?

• We have a team of experts who combine expertise in formulation and process development with proven capabilities in spray drying.
• We have extensive expertise and experience in performing protein/peptide spray drying formulation development.
• We offer comprehensive protein/peptide spray drying formulation analysis and physical characterization solutions.
• Our skilled scientists and engineers have decades of experience in solid dosage and spray-drying processing.
• We have a wide selection of downstream processing technologies including granulation, roller compaction, and tableting.
• We provide flexible and tailored solutions to meet our customers' specific needs and requirements.
• Fast and efficient services ensure that our customers' projects are delivered on time.

Publication

CD Formulation is at the forefront of protein and peptide formulation development, dedicated to providing unparalleled protein/peptide spray drying formulation development services to the pharmaceutical industry. Our formulation scientists combine state-of-the-art spray drying technology with the latest knowledge of protein and peptide science 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.