Antibody Production Process Characterization and Validation (PC/PV) Service

Process characterization (PC) and process validation (PV) are crucial phases in the lifecycle of biopharmaceutical products. These rigorous processes ensure that every aspect of antibody production is optimized to meet predefined criteria consistently. At Creative Biolabs, we understand the importance of antibody process characterization and validation in delivering high-quality biopharmaceutical products. Through meticulous process understanding and strategic implementation, our service aims to support the characterization and validation of antibody production processes, applying principles derived from regulatory guidelines and mechanistic modeling.

Process Characterization (PC) & Process Validation (PV)

PC involves an in-depth understanding of how different process parameters impact product quality. The primary goal during this stage is to identify critical process parameters (CPPs) that significantly impact the critical quality attributes (CQAs) of the product, such as purity, potency, and stability. Through extensive design of experiments (DoE) and statistical analyses, PC helps in developing a robust control strategy that mitigates risks associated with scaling up production processes.

PV is a series of activities that involves collecting and analyzing data to ensure that a product can be consistently produced to a predetermined standard. Serving as a bridge between pilot-scale production and commercial manufacturing, PV is vital for both process validation and regulatory submissions. PV comprises three key stages: process design, process qualification, and continued process verification.

Our Services

Throughout the entire PC system, Creative Biolabs has developed a comprehensive methodological framework. By offering a range of PC services, including risk assessment, scale-down model development, design of experiment (DOE), critical process parameter (CPP) identification, and design space establishment,  a complete process control strategy is ultimately crafted. These services enable comprehensive and in-depth evaluation of the rationality of the operational ranges for production process parameters and the scientific validity of control strategies. This control strategy will be validated during the subsequent PV phase and implemented in future commercial production processes.

Creative Biolabs boasts a robust process and production team with extensive experience in PC and PV projects. Our experts have substantial expertise in providing PC/PV services for clients,  ensuring the smooth delivery of projects and achieving completion in as quickly as 12-15 months.

Key Services

• Scale down model development & qualification
• Failure modes and efffects analysis (FMEA)
• Upstream and downstream process characterization
• Design of experiment or OFAT (one factor at a time) unit operation screening
• Critical process parameter assessment/risk assessment
• Process performance qualification (PPQ)
• Continued process verification
• Worst-case condition confirmation

About Creative Biolabs

As a specialized biopharmaceutical CDMO, Creative Biolabs is committed to providing efficient and high-quality antibody CDMO services to global partners, aiding them in reducing the time required for antibody drugs to enter clinical trials and reach the market. Our service range includes cell line development, antibody production process development and antibody quality studies. We possess a strong process development team with extensive knowledge and experience in PC and PV projects, ensuring the smooth delivery of clients' projects. Clients can leverage our cutting-edge facilities, expert team, and comprehensive capabilities to drive successful antibody development programs and achieve a competitive advantage in the global market. If you have any PC/PV requirements, please don't hesitate to contact us.

For research use only. Not intended for any clinical use.