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.
Fig. 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.
Fig. 2. Workflow of Proteins & Peptides Formulation Research and Development. (CD Formulation)
Before beginning formulation development, pre-formulation research is typically necessary to determine the optimal combination and ratio of raw materials and excipients to meet specific product requirements.
During this stage, our scientists conduct comprehensive screening and evaluation of stable excipients for protein/peptide preparations, aiming to identify the most suitable combination and ratio of raw materials and excipients. This process may involve testing and evaluating different carrier proteins, stabilizers, antioxidants, etc., to determine their optimal ratios for formulation use.
Additionally, we consider other properties of the formulation, such as pH, viscosity, and rheology, among others, to ensure the stability and efficacy of the final product.
At this stage, we will screen the optimal formulation tailored to your product's application field and delivery route. This process aims to stabilize the drug substance and improve bioavailability, encompassing liquid preparations, sterile preparations, lyophilized preparations, spray-dried powders, and more.
Based on the application field and delivery route of your product, we will design and develop the optimal drug delivery method for you. This includes, but is not limited to, oral formulations, transdermal formulations, injections, pulmonary delivery formulations, intranasal delivery formulations, buccal delivery, and some innovative drug delivery routes.
At this stage, we will comprehensively consider factors such as drug characteristics, packaging methods, quality standards, stability, protective performance, and sustainability, based on your product's specific characteristics. This is to ensure the quality and safety of your product.
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
- 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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