Compliance and Validation Consulting Services for a Leading Pharmaceutical Innovator in Antibody-Drug Conjugates

Due to its high specificity, established curative effects, and superior pharmacokinetics, the antibody drug has attracted great attention across the pharmaceutical industry. Antibody-drug conjugates (ADCs) in China have developed rapidly in recent years, thanks to the new innovative drug-support policies and more favorable research and development investment market. Many antibody drugs have been approved to enter the market, and marketing applications and approvals involving ADCs are also growing.

Client Background

As a leading pharmaceutical enterprise of new drugs, the client is dedicated to researching and developing antibody-drug conjugates, constantly expanding indications, exploring combination therapies, and steadily promoting commercialization. Given the growing market of the antibody-drug conjugates and based on the development needs of the client, a new antibody project is initiated in the hope of continuously improving the international competitiveness of innovation.

Project Challenges

• The project-complies with requirements of FDA cGMP, EU GMP and NMPA GMP regulations and relevant guidelines, especially EU GMP Annex 1 Manufacture of Sterile Medicinal Products.

• Equipment and instruments qualification and computerized system validation consulting based on ASTM and ISPE GAMP 5 (second edition).

Scope of Services

• GMP compliance consulting services for the whole project lifecycle.

• Systems, facilities and equipment qualification and validation consulting services.

• Aseptic process simulation (APS).

• Airflow pattern studies for isolated filling line.

AUSTAR Contribution and Customer Benefits

• Provided support and services in phase based on the project schedule to ensure systems/facilities and equipment meet the desired requirements of the client and regulatory expectations.

• EU GMP Annex 1 compliant aseptic process simulation (APS) and airflow pattern studies for isolated filling line to effectively identify and control the sterility risk, and provide persuasive evidence for the client’s sterility assurance system.

• ISPE GAMP 5 (second edition) compliant computerized system validation services to ensure the system stability, reliability and compliance, and provided effective support for the client’s key business processes.

• AUSTAR invited several European and American GMP experts and technical consultants to participate in the project to develop the client's knowledge and skills in GMP compliance, guide the project execution, facilitate the formation of new quality productivity, and further strengthen its competitiveness.