Therapeutic Proteins & Peptides Formulation Process Development

Formulation process development is a key step in the commercial production of almost all protein and peptide biopharmaceuticals. It aims to develop cost-effective, stable, reliable and validated manufacturing processes, and maximize the yield of high-quality products to achieve large-scale production. CD Formulation has a stable and efficient protein/peptide biologics formulation process development platform, which can realize the development of water injections, prefilled injections and lyophilized powder injections. Whether you need complete process development or process development at any stage, we can provide you with customized solutions to ensure that your protein/peptide biologics can be successfully commercialized.

The Importance of Therapeutic Proteins & Peptides Formulation Process Development

Formulation process development refers to the process of studying, designing and optimizing pharmaceutical processes to make drug preparations have better stability, purity, solubility, bioavailability and other characteristics during the production process, thus achieving higher efficacy and better preparation quality. Formulation process development, an important link in pharmaceutical production, directly affects the quality, effect, and production cost of drugs. It is one of the key links to ensure the quality and effect of drug production.

For therapeutic proteins and proteins, the current clinical administration is usually based on stock solution, but because proteins are easily affected by factors such as temperature, pH value, ionic strength, etc., they easily lose their activity during production, processing, transportation, storage, and use, so appropriate formulation processes are needed to protect them. Common formulation processes include freeze-drying, spraying, microspheres, microcapsules, nanocarriers, and other technologies, which fix proteins in carrier materials by encapsulation, compounding, and other methods to improve their stability and bioavailability.

Fig. 1 Protein instability: possible degradation pathways. (Akbarian M, et al., 2022)

Explore Our Therapeutic Proteins & Peptides Formulation Process Development Services

CD Formulation has built a mature protein/peptide formulation process development service platform. Our formulation process development team has the most advanced technology and rich practical experience, providing customers with formulation prescriptions and process development services for different types of biological products such as recombinant proteins, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, etc., in different dosage forms.

Our formulation process development laboratory is equipped with complete formulation process development equipment and related testing instruments, which can realize the development of multiple dosage forms such as macromolecular pre-filled injections, lyophilized powder injections for injection, eye drops, oral solutions, inhalation preparations, etc.

At the same time, we can quickly screen out suitable prescriptions according to the drug properties of your therapeutic proteins and peptides to support the one-stop service needs required for customers' biopharmaceutical IND/BLA applications.

Our protein/peptide formulation process development services include:

• High-throughput screening of formulation buffer systems and excipients.
• Understand the factors affecting protein/peptide stability and possible degradation pathways and degradation products through forced degradation studies.
• Conduct comparative research on different formulations through DOE design to quickly select the best formulation.
• Development, optimization, confirmation, and scale-up of freeze-drying formulations and freeze-drying processes.
• Development, optimization, confirmation, and scale-up of spray drying processes.
• Selection, compatibility study, and integrity testing of drug container systems such as packaging materials and packaging.
• Development of related processes during batching and filling.
• Development of pre-filling related processes.
• Development of aseptic filling processes.
• Sterile filtration research.
• Process development adapted to each stage.
• Long-term, accelerated, influencing factors, compatibility, and other stability studies in accordance with ICH guidelines.
• Provide technology transfer and process scale-up support for GMP production and filling processes.

Single/Integrated Proteins & Peptides Formulation Process Development Services

Our protein/peptide formulation process development team can undertake projects at the following different R&D stages, providing sufficient flexibility to ensure that any project can start R&D work in a timely manner at any stage.

Our services cover formulation drugability evaluation, formulation development, formulation process development, and corresponding technology transfer, packing compatibility, and influencing factors.

For projects that are carried out to the late clinical, we can also further provide commercial formulation optimization and characterization, freeze-drying process optimization and characterization, and commercial process development and characterization services to support the commercialization process of customer products.

Fig. 2 Therapeutic proteins/peptides formulation process development. (CD Formulation)

Formulation Process Development

We provide DoE-based formulation development and characterization, druggability assessment of protein and peptide molecules, development of high-concentration formulations, and filling and lyophilization process development services. Our experts will also evaluate the suitability/compatibility of instruments and contact materials and identify critical process parameters.

Lyophilization Cycle Process Development

We support your early and late-stage formulation and dosage form decisions. You may need lyophilization technology to stabilize your product and prevent it from degrading to an unacceptable level in the liquid state. Especially for late-stage development and expected commercial production, lyophilization cycle development and scale-up ensure cost-effective production processes, ensuring product critical quality attributes (CQAs).

Our experts use the latest modeling techniques combined with process analytical technology (PAT) tools to evaluate the optimal lyophilization cycle process and ensure smooth scale-up and technology transfer to the production site.

Process Optimization and Characterization

We can evaluate the importance of different unit operation parameters based on risk assessment and study the impact of key process parameters on relevant product quality parameters (including critical quality attributes).

Process Validation and Transfer

We will help you manage process transfer and ensure the smooth completion of overall production. Controls are exercised at every step of the production process to ensure that the finished product meets all quality attributes.

Our Proteins & Peptides Formulation Process Development Capabilities

• Cell bank storage.
• GE Xcellerex XDR 2000 bioreactor.
• Virus filtration.
• Tangential flow filtration (TFF).
• Freeze-drying of intermediates.
• Lyophilizer.
• Extractables and leachables (E&L) studies.
• Full aseptic filling capabilities, including lyophilization and pre-filled syringes.

Our Technology Platforms

Why Choose Us for Therapeutic Proteins & Peptides Formulation Process Development?

• Our formulation process development team has experience in developing different types of protein and peptide biomacromolecules.
• We have unique experience in the analysis of key process control points and process impurity sources of protein and peptide products.
• Our formulation process development team has successfully developed dozens of finished formulations for a variety of protein and peptide molecules, with accumulated rich experience in the development of lyophilized formulations, liquid formulations, and spray-dried formulations.
• Our formulation process development laboratory is equipped with a series of advanced process development and testing equipment, including Uncle, MFI, viscometer, desktop filling machine, etc.
• We have experience in successfully completing the production scale-up of milligrams to kilogram-level protein and peptide products.
• In accordance with the requirements of ICH guidelines, we complete process development and form process reports to strongly support clinical applications.
• We provide flexible experimental options to meet the needs of different customers.

Publication

CD Formulation's professional formulation process development team is not only capable of quickly and efficiently screening out long-term stable low-concentration protein preparations, but also capable of quickly and efficiently screening out long-term stable high-concentration protein preparations, and will fully evaluate the stability of the target protein in the preparation. Please don't hesitate to contact us if you are interested in our services. We look forward to cooperating with you.

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.