Therapeutic Proteins & Peptides Process Characterization and Process Validation

Process characterization and process validation are important parts of all new drug pre-marketing research and development, as well as are also prerequisites for products to obtain marketing authorization through registration. They are designed to ensure that the drug production process is always under control and can continuously produce products that meet quality requirements. As a provider of protein and peptide biopharmaceutical development and manufacturing services, CD Formulation has a strong process development, production, and validation team, with strong knowledge accumulation and sufficient practical experience in process characterization and process validation projects, aiming to provide global customers with process characterization and process validation services to ensure the smooth delivery of their project.

What are Process Characterization and Process Validation?

• Process characterization (PC) is a series of systematic and complex work to purposefully change operating parameters to identify critical process parameters (CPP) that affect critical quality attributes (CQA) so that the parameters and control strategies determined in the process characterization are followed in production to ensure that product quality continues to meet requirements.
• Process validation (PV) refers to the entire process from process design to production, through the collection and evaluation of data, to prove that the process can continuously produce products that meet quality standards. The purpose of PV includes process validation, identification of critical process parameters based on risk assessment, and implementation of proven control strategies.

PC studies are usually carried out after clinical phase II and end in clinical phase III, while PV is generally carried out in clinical phase III and ends before commercial production.

Fig. 1 Process characterization and process validation in the drug development process. (CD Formulation)

Explore Our Therapeutic Proteins & Peptides Process Characterization and Process Validation Services

CD Formulation uses the quality by design (QbD) approach to build a complete and audited process validation system, including process characterization (PC), process validation (PV), and continuous process verification (CPV). Relying on strong platform capabilities and flexible solutions, our team of experts provides systematic process characterization (PC) services and continuous lifecycle management, especially in process validation (PV) of later projects. We use DOE experimental design, apply statistical reduction models in decision-making, and determine the relationship and interaction between inputs (such as process parameters) and outputs (such as critical quality attributes).

Our process characterization (PC) studies help you identify critical process parameters (CPP), quality attributes, control strategies, and design space, and justify the expansion of the operating range of the process and the rationality of the process control strategy.

Our key services include:

• Process parameter risk assessment.
• Identification of critical quality attributes (CQAs).
• Model building.
• Identification of critical process parameters (CPP).
• Multi-factorial design of experiments (DoE) study of process parameters.
• Virus clearance validation.
• Process characterization study.
• Cell culture process validation.
• Purification process validation.
• Stability study of purified intermediates.
• Impurity challenge study, risk assessment.
• Material compatibility study.
• Analytical method validation.
• Process validation integrated control strategy.
• Continuous production of validation (PPQ) batches.
• Release testing.
• ICH stability study.

Process Characterization (PC) Services for Therapeutic Proteins & Peptides

To meet the needs of different customers, we provide two types of process characterization (PC) services.

• For products with accelerated approval pathways or monoclonal/symmetrical bispecific antibodies in liquid dosage forms, we use rapid PC service.
• For complex molecules such as proteins and asymmetric bispecific antibodies, we use standard PC service.

Available Process Characterization (PC) Services Include:

• Small-scale model establishment.
• Upstream and downstream and formulation process characterization studies.
• Purification media and membrane filter studies.
• Critical process parameter evaluation/risk assessment.
• Media storage stability studies.
• Purification impurity challenge studies.
• Continuous process validation studies.

Available Process Characterization (PC) Procedures

The purpose of process characterization is to establish and acquire process knowledge and understanding, which requires the use of risk assessment, experimental design and other tools. Our process:

Fig. 2 Process characterization (PC) flow. (CD Formulation)

• Define and describe the production process: Determine the key quality attributes for process evaluation.
• Risk assessment of process parameters: Confirm possible key process parameters through risk assessment.
• Establish and confirm the scale-down model: Establish a scale-down model and conduct comparability studies.
• Process characterization study: Design experiments on the scale-down model to study the impact of high-risk process parameters on process performance and product quality, using single-factor experiments or experimental design (DoE) methods.
• Establish control strategy: Through process characterization studies, a list of critical quality attributes and critical process parameters is determined, as well as the acceptable ranges of critical quality attributes and the design space of critical process parameters.
• Update risk assessment: conduct risk assessment is repeated in conjunction with data from the process characterization study, which is used to determine the final list of critical quality attributes and critical process parameters.

Process Validation (PV) Services for Therapeutic Proteins & Peptides

• 3 batches of commercial production.
• Material compatibility studies.
• In-use compatibility studies.
• Cleaning validation.
• Media/buffer shelf life validation.
• UF membrane/resin life validation.
• Post-sterilization material retention time validation.
• Consumables/packaging material-related validation.
• Cell bank-related validation.
• Stability studies.
• Method validation.
• Process validation batch protein characterization studies.
• Shipping validation.
• Purification intermediate stability validation.
• Process-related impurity studies.

Why Choose Us for Therapeutic Proteins & Peptides Process Characterization and Process Validation?

• All of our PC/PV services are based on the internationally accepted QbD concept and rigorous DoE experimental design methods.
• Our team of scientists and researchers have experience in drug development and production based on the QbD concept, helping clients obtain IND approval for multiple projects.
• We have a state-of-the-art facility equipped with the latest technology and equipment to conduct thorough process characterization and validation studies.
• Our team works closely with clients to develop customized protocols and methodologies tailored to their specific needs.
• We are well-versed in the regulatory requirements for therapeutic proteins and peptides process characterization and validation. Our team ensures that all studies are conducted in compliance with relevant regulations and guidelines.
• We provide flexible experimental options to meet the needs of different customers.

Publication

CD Formulation provides systematic process characterization (PC) and process validation (PV) services to support in-house process development or product commercialization of established processes. 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.