Proteins & Peptides High-concentration Formulation Development

Converting therapeutic proteins or peptides into highly concentrated, stable, and easy-to-use clinical formulations is fraught with great challenges. Basic qualifications for syringe formulations must be considered, such as appropriate physicochemical stability, container material compatibility, and viscosity to support acceptable in-syringe shelf life and convenience in terms of syringe performance. CD Formulation specializes in this area of high-concentration protein/peptide formulations and is committed to providing the pharmaceutical industry with cutting-edge formulation development to meet unmet industry needs.

About Proteins & Peptides High-concentration Formulation

High-concentration protein/peptide subcutaneous drug products are valuable alternatives to intravenous applications. They can improve drug stability and storage life, reduce the number of injections, and improve patient convenience and compliance.

Protein/peptide high-concentration formulation development refers to a process in which the drug concentration reaches a higher level by optimizing the formulation formula and process parameters when preparing protein or peptide drugs. Formulating high-concentration proteins and peptides can be challenging due to factors such as stability, solubility, and aggregation. In the development of high-concentration protein/peptide formulations, factors that are often considered include drug solubility, condensed state stability, viscosity, permeability, rheology, freeze-thaw stability, etc. In addition, the development of high-concentration formulations requires combining physicochemical properties and biological activity, optimizing production processes and quality control processes, and ensuring that the prepared drugs meet the requirements of drug therapy.

Explore Our Proteins & Peptides High-concentration Formulation Development Services

Subcutaneous injection of high-concentration protein/peptide drugs is an effective alternative to intravenous administration. For certain applications, such as intravitreal administration, high-concentration formulations are the only viable option.

As formulation science experts, we are experienced in overcoming the challenges associated with high-concentration protein/peptide formulations, including aggregation, viscosity, injectability, and manufacturability.

Our team of highly qualified protein experts is able to develop the following protein/peptide high-concentration formulations to ensure drug stability and bioactivity.

Fig.1 Protein/peptide high-concentration formulation development. (CD Formulation)

• Protein/peptide High-concentration Solution Formulation
• Protein/peptide High-concentration Nanosuspensions
• Protein/peptide High-concentration Nanoemulsions
• Protein/peptide High-concentration Freeze-dried Formulation

Our Solutions for High-concentration Formulation

A key challenge to overcome when formulating high-concentration protein/peptide formulations is high viscosity. Higher concentrations mean higher viscosity and high-viscosity protein/peptide solutions, which are unstable and prone to aggregation.

Our scientists use a carefully designed, science-based approach to meet established key quality attributes, such as high-concentration, low-viscosity formulations for maximum efficacy and low injection volume. Throughout the formulation development process, our formulation scientists use the following strategies to reduce viscosity and optimize product stability.

• Use viscosity-reducing excipients, such as certain amino acids or salts.
• Adjust pH.
• Screen and test excipients that stabilize proteins.

It should be noted that we will provide you with a high-concentration lyophilized formulation if the above strategies cannot improve the stability of the high-concentration liquid formulation.

Our Analytical Testing Capabilities

Protein Quantification: UV-Vis spectroscopy, Bradford assay,  BCA assay...

Protein Purity: SDS-PAGE, HPLC, and Western blot analysis...

Protein Identification: Mass spectrometry(MS), amino acid analysis, C/N-terminal sequencing, and peptide mapping analysis...

Aggregation Analysis: Dynamic light scattering(DLC), size exclusion chromatography(SEC), sedimentation velocity analysis...

Stability Testing: Accelerated stability testing, real-time stability testing, in-use stability testing...

Forced Degradation Studies: High-temperature studies, pH studies, photostability studies, oxidation studies...

Why Choose Us for High-concentration Formulation Development?

• We have extensive expertise and hundreds of successful projects in executing protein/peptide high-concentration formulation development.
• We have the most advanced strategies and technologies for stabilizing proteins/peptides and improving viscosity.
• We provide comprehensive analytical testing capabilities to support the development of a variety of high-concentration formulations, including protein/peptide high-concentration solutions, nanosuspensions, nanoemulsions, and freeze-dried formulations.
• 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 always at the forefront of protein and peptide formulation development, dedicated to providing unparalleled protein/peptide high-concentration formulation development services to the pharmaceutical industry. Our formulation scientists use the latest protein and peptide science knowledge to create formulations that optimize stability, appearance, and manufacturability. Please contact us today to get your exclusive solution if you are interested in our services.

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.