The success of therapeutic proteins and peptides depends on delivering the bioactive molecule in an optimal dosage form to the site of action. The design and development of stable formulations are critical for any novel protein and peptide therapeutics during this process. As one of the global leaders in formulation development, CD Formulation is committed to providing a range of formulation development services for therapeutic proteins and peptides to help customers solve drug delivery and stability challenges. Whether developing new therapeutic protein and peptide formulations or optimizing the stability of existing formulations, our scientists provide professional support and solutions.

What is the Difference Between Protein & Peptide and Small Molecule in Formulation Development?

The main difference between proteins & peptides and small molecules in formulation development is the complexity and specific requirements of the molecules themselves, as well as the formulation techniques needed to ensure their stability and effectiveness, including:

• More complex molecular structures: Biological macromolecules usually contain a large number of amino acid residues, which require comprehensive consideration of the conception and undetermined stability of primary and higher-order structures, including amino acid sequence, spatial conformation, electrostatics, hydrophobicity, and glycosylation modifications, and other characteristics.
• Poor stability: More susceptible to factors such as heat, light, oxidation, pH, etc.
• More excipients: Screening and optimization of more, appropriate excipients are needed to maintain the stability and activity of the protein or peptide chain, including buffers, protectants, and surfactants.
• More stable delivery system: Easily degraded by enzymes in the gastrointestinal tract, causing protein drugs to lose activity in the intestine and affecting the efficacy of the drug. In addition to chemical modification, innovative drug delivery systems such as nano-delivery, controlled-release delivery, and targeted delivery should be given priority.

Explore Our Proteins & Peptides Formulation Development Services

CD Formulation provides formulation development services for various types of pharmaceutically active molecules, including monoclonal antibodies, recombinant proteins, fusion antibodies, bispecific antibodies, multispecific antibodies, antibody fragments (such as Fab, scFv), and therapeutic peptides. Our team of experts has extensive experience and expertise and can design and optimize the most appropriate formulation scheme based on customer needs and the characteristics of active pharmaceutical molecules.

Whether it is the initial screening stage of drug active molecules or the later stage of drug development, we can provide customers with a full range of formulation development services to help them achieve successful commercialization of their drugs. Our formulation development services include, but are not limited to:

Proteins & Peptides Liquid Formulation Development

Proteins & Peptides Sterile Formulation Development

Proteins & Peptides Buffer-free Lyophilized Formulation Development

Proteins & Peptides High-concentration Formulation Development

Proteins & Peptides Lyophilization Formulation Development

Proteins & Peptides Spray Drying Formulation Development

Fig.1 Proteins/peptides formulation development. (CD Formulation)

Our Solutions for Proteins & Peptides Formulation Development

CD Formulation has first-class analytical instruments and advanced production equipment for the development of therapeutic protein and peptide formulations. We can provide either a fully integrated one-stop service or a single service according to the customer's R&D goals and project needs. Our solutions include but are not limited to:

Comprehensive Characterization:

We offer a range of analytical techniques to fully characterize proteins and peptides, including protein identification, sequence analysis, post-translational modification analysis, protein quantification, and protein-protein interaction studies, etc.

Stability Studies:

Our team conducts stability studies to assess the physical and chemical stability of proteins and peptides under various conditions, including temperature, pH, and agitation.

Formulation Optimization:

We work closely with our clients to develop customized formulations that optimize the stability, solubility, and bioavailability of proteins and peptides.

Lyophilization Services:

We provide lyophilization services to help stabilize proteins and peptides for long-term storage and transportation.

Scale-Up Manufacturing:

We offer scale-up services to facilitate the transition from laboratory-scale formulation development to large-scale manufacturing.

Regulatory Support:

Our team can assist with regulatory submissions for proteins and peptides, including preparing documentation for FDA approval.

Collaboration and Consultation:

We collaborate with our clients throughout the formulation development process, providing expert guidance and support to ensure successful outcomes.

What Problems Can We Solve for Our Services?

• Druggability assessment.
• New therapeutic protein and peptide formulation development.
• Existing formulations optimization of therapeutic proteins & peptides.
• Feasibility analysis of formulation development.
• Therapeutic protein and peptide characterization and batch-release testing.
• Pilot production.
• Analysis method development and validation.
• Analytical method transfer.

Why Choose Us for Proteins & Peptides Formulation Development?

• A wide range of services, from therapeutic protein & peptide discovery, and CGMP production to formulation development and manufacturing.
• End-to-end capabilities, from pre-formulation studies to CGMP commercial production.
• Extensive expertise in therapeutic protein & peptide formulation development, including solutions, injections, capsules, emulsions, nanoformulations, etc.
• Comprehensive analysis of therapeutic protein & peptide characterization and CMC analysis testing capabilities.
• Analytical laboratories and manufacturing facilities that comply with CGMP requirements.

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With years of experience and successful cases, CD Formulation is committed to providing customers with high-quality, reliable therapeutic protein and peptide formulation development services. Our team focuses on continuous innovation, continuous improvement of formulation, and strict compliance with the quality management system to ensure that products meet international standards. Please contact us today to get your exclusive solution if you are interested in our services.