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Proteins & Peptides Formulation Research and Development

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The development of stable formulations is an essential step for every new protein or peptide therapeutic. Thanks to our stable and efficient protein/peptide formulation development platform technology, CD Formulation provides high-quality formulation development services for various therapeutic proteins/peptides, such as monoclonal antibodies, bispecific antibodies, and fusion proteins. Our team of highly qualified formulation experts has extensive experience and technical knowledge, enabling us to provide a full range of formulation research and development services. These services include preliminary stability research, optimized formulation development, formulation process optimization, and other related aspects.

Importance of Protein & Peptide Formulation Development

Protein and peptide drugs constitute a class of drugs with significant clinical value, characterized by high specificity and activity. However, they are prone to degradation or denaturation, resulting in low bioavailability. Therefore, a crucial step in translating candidate therapeutic proteins and peptides into clinically effective treatments is to formulate them into dosage forms. Nonetheless, formulation development can be a complex and challenging process due to the high sensitivity of proteins and peptides to various process stresses, temperatures, and environmental factors. To ensure the effectiveness and safety of protein and peptide drugs, formulation development requires systematic research and optimization, which involves careful consideration of factors such as structural integrity, aggregation state, stability, and pH. These considerations are essential for achieving effective clinical application.

Formulation strategies for enhancing protein and peptide deliveryFig. 1. Formulation strategies for enhancing protein and peptide delivery. (Choonara BF, et al., 2014)

Explore Our Protein & Peptide Formulation R&D Services

As experts in protein and peptide formulation development, CD Formulation is dedicated to offering our customers unparalleled research and development services in this field. Our rational formulation development strategy is built upon an extensive understanding of the physicochemical stability of various proteins and peptides. We combine this knowledge with innovative technologies and cutting-edge analytical methods to assess the stability of bioassays across different formulations.

We conduct systematic research and optimization to ensure that our customers receive high-quality protein and peptide formulation products.

Workflow of Proteins & Peptides Formulation Research and DevelopmentFig. 2. Workflow of Proteins & Peptides Formulation Research and Development. (CD Formulation)

Supporting Protein & Peptide Formulation Development Analysis Services

CD Formulation offers comprehensive protein and peptide formulation development analysis services to ensure the safety, effectiveness and stability of your products, including but not limited to:

Physicochemical Characterizatio

  • Structure Characterization
  • Particle and Aggregation State Characterization
  • Viscosity Analysis
  • Stability and Thermal Denaturation Analysis
  • pH Analysis
  • ...

Quality Control Testing

  • In Vitro Release Testing
  • Product-related Impurity Analysis
  • Solvent and Volatile Impurity Analysis
  • Storage Stability Testing
  • Forced Degradation Study
  • Immunogenicity Analysis

Our Expertise

  • Recombinant Proteins
  • Monoclonal Antibodies
  • Bispecific Antibodies
  • Multispecific Antibodies
  • Antibody fragments (e.g. Fab, scFv)
  • Antibody Drug Conjugates (ADCs)
  • Therapeutic Peptides

Why Choose Us for Protein & Peptide Formulation Research and Development?

  • Flexible experimental design and formula development capabilities.
  • Expertise with extensive experience in various drug delivery routes.
  • It has a variety of protein & peptide formula innovative technologies, including microneedles, liposomes, nanoparticles, nanoemulsions, etc.
  • Comprehensive analysis and characterization capabilities enable thorough analysis of the advanced structure and stability of proteins & peptides.
  • End-to-end solutions, providing one-stop service from recipe screening to CGMP commercial manufacturing.

The goal of formulation development is to optimize the properties of the protein or peptide to enhance its bioavailability, minimize degradation, and increase its shelf-life. CD Formulation is committed to providing efficient and high-quality protein and peptide formulation R&D services to help our clients accelerate the drug development process, reduce development risks, and achieve a faster introduction to the market. Please feel free to contact us if you are interested in our services.

References

  1. Choonara BF, Choonara YE, Kumar P, et al. A review of advanced oral drug delivery technologies facilitating the protection and absorption of protein and peptide molecules. Biotechnol Adv. 2014, 32(7):1269-1282.
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CD Formulation is an expert in formulation science and pharmaceutical process development in therapeutic proteins & peptides, dedicated to supporting biotherapeutics development and production...

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