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Proteins & Peptides Formulation Screening

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In the formulation research stage of proteins and peptides, formula screening based on their final route of administration and clinical application requirements is a key link to ensure the success of product development. As an expert in formulation development, CD Formulation has been at the forefront of protein and peptide formulation screening and development and is committed to helping you achieve success in product development and commercialization. Our team will use the most advanced technologies and methods to screen and design the optimal formulation based on the drug's properties, physical and chemical properties, and expected route of administration. We will ensure that the designed formulation has good performance, stability, solubility, and bioavailability through precise experiments and testing.

Why Conduct Early Formulation Screening Trials?

Misbehaving proteins can unfold, clump, and destroy everything, screening for the best proteins and formulations helps get all the right data to advance the best candidates, including:

  • Optimizing formulation parameters: By conducting early screening trials, the most suitable formulation parameters for a particular protein or peptide, such as buffer composition, pH, stabilizers, and excipients can be identified, helping to ensure the stability and efficacy of the protein or peptide drug product.
  • Assessing stability and shelf-life: Formulation screening trials can help to assess the stability of proteins and peptides under different storage conditions, such as temperature, humidity, and light exposure. This information is crucial for determining the shelf-life of the drug product and ensuring its effectiveness over time.
  • Improving bioavailability: Formulation screening trials can help to improve the bioavailability of proteins and peptides by optimizing their formulation for oral, subcutaneous, or other routes of administration, enhancing the therapeutic efficacy of the drug product and improving patient outcomes.
  • Minimizing immunogenicity: Proteins and peptides can be immunogenic, triggering an immune response in the body. The early formulation screening trials contribute to immunogenicity, leading to safer and more effective drug products.
  • Streamlining development timelines and costs: Researchers can identify promising formulations and eliminate less favorable ones early in the development process, helping to streamline development timelines, reduce costs, and increase the likelihood of success in later stages of development.

Explore Our Proteins & Peptides Formulation Screening

Thanks to years of continuous exploration of protein and peptide science, CD Formulation has made formulation screening the focus of our services. At this stage, our scientists will conduct formulation screening based on the customer's product properties, administration routes, clinical application needs, and other factors, especially the delivery route.

Our formulation screening and development services are an iterative process. Throughout the formulation screening process, we will test different types of excipients, such as surfactants, buffers, preservatives, and salts to stabilize the therapeutic protein or peptide. Once the target formulation is identified, we will conduct a proof of concept including stability, efficacy, and feasibility to ensure that the formulation is consistent with your product.

In order to stabilize your protein or peptide raw material to change the release profile and maximize bioavailability, our protein chemists and formulators will continue to provide you with support in the following areas:

  • Solutions.
  • Orally disintegrating tablets.
  • Enteric-coated capsules.
  • Lyophilized preparation.
  • Nanoformulation.
  • Spray dry powder.

Our Solutions for Proteins & Peptides Formulation Screening

  • Excipient screening and formulation design: Consider factors such as pH, temperature, buffer composition, and excipients to determine the best formulation for your protein or peptide.
  • Stability testing: Evaluate the stability of your protein or peptide under various stress conditions, including temperature, agitation, and freeze-thaw cycles.
  • Solubility assessment: Provides solubility screening services to determine the most appropriate conditions to maximize solubility and prevent aggregation of biomolecules.
  • Functional assays: Conduct a wide range of bioassays to evaluate the functional activity of your protein or peptide under different formulation conditions.

Fig. 1 Early formulation screening services for proteins and peptides.Fig.1 Early formulation screening services for proteins and peptides. (CD Formulation)

Our Expertise for Supporting Therapeutic Protein and Peptide Drug Delivery

  • Oral preparations, liquid or solid.
  • Parenteral preparations, i.e. injection.
  • Ocular delivery, topical or injection.
  • Pulmonary delivery, inhalation.
  • Intranasal delivery, aerosol.
  • Buccal delivery, oral dissolving film.

Key Technical Advantages:

  • Protein and peptide expertise across multiple dosage forms and drug delivery systems.
  • Advanced analytical characterization, including physicochemical characterization of proteins and peptides, in vitro cell culture studies, in vivo potency assays, etc.
  • Perform comprehensive stability studies under required storage conditions.
  • Supported by a variety of innovative technologies, including liposome technology, nanoparticle technology, microneedle technology, hydrogel technology, etc.
  • One-stop CDMO service from formulation screening and design, and process development to GMP formulation manufacturing including fill and finish.

Why Choose Us for Proteins & Peptides Formulation Screening?

  • Our team of scientists has many years of experience in protein and peptide formulation screening and development.
  • We perform dozens of proteins and peptides formulation screening projects every year,with a variety of proven track record of successful projects.
  • Our lab is equipped with the latest technology and equipment for protein and peptide formulation screening, allowing us to deliver high-quality results in a timely manner.
  • We prioritize confidentiality and data security, ensuring that your project information is kept secure and protected throughout the screening process.
  • Provides flexible experimental design and testing options can meet any customer's specific needs.

Publication

Published Data

Technology: Formulation screening for biotherapeutics by

Journal: J Pharm Sci.

IF: 2.7

Published: 2011

Results:

The authors demonstrate the utility of combining a design of experiment (DOE) approach with high-throughput formulation screening to identify the main factors affecting protein thermostability and solution viscosity. Different monoclonal antibody (mAb) formulation variables were evaluated in the study to achieve optimization of two parameters thermostability characterized  and (ii) viscosity, which are characterize by High-throughput measurements. An experimental design was used to estimate the significance of all factors, including interaction effects. The result show that the described high-throughput methods are well suited for characterization of multiple protein formulation compositions with minimized resources such as time and material,and the DOE approach can be successfully applied to the screening of mAb formulations early in the development lifecycle.

CD Formulation's protein and peptide early-stage formulation screening services are specifically designed to support preclinical research. Whether you have experience in therapeutic proteins and peptide formulation or not, our team of experts will provide you with a custom solution. Please don’t hesitate to contact us to get the best formulation for your protein and peptide and take it to the next level.

References

  1. Floyd JA, Shaver JM, Gillespie AJ, et al. Evaluation of Crystal Zenith Microtiter Plates for High-Throughput Formulation Screening. J Pharm Sci. 2020, 109(1):532-542.
  2. He F, Woods CE, Trilisky E, et al. Screening of monoclonal antibody formulations based on high-throughput thermostability and viscosity measurements: design of experiment and statistical analysis. J Pharm Sci. 2011, 100(4):1330-40.
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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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