The Ultimate Safeguard: Compliance-oriented Design

Case Study：GMP Design Review for ADC

Antibody-Drug Conjugates (ADCs) represent an innovative category of antibody-based drugs formed by the conjugation of antibodies or antibody fragments targeting specific antigens with an effective payload through a linker. Compared to traditional antibody drugs, ADC products amalgamate the potent effects of conventional small-molecule drugs with the targeting precision of antibody drugs. This integration enables a reduction in systemic toxicity and a more selective delivery of the payload to cancer cells within the tumor microenvironment or other designated target cells.

Given the expanding indications and outstanding efficacy of ADC drugs, pharmaceutical companies worldwide are intensifying their investment in ADC drugs, resulting in a continual surge in pipeline transactions. In recent years, the approval count for ADC drugs has escalated rapidly, and as of the end of February 2023, a total of 15 ADC drugs have received approval and are commercially available globally.

Background:

The client is a global biotechnology company, which focuses on the development and commercialization of innovative and affordable antitumor drugs to improve the therapeutic effect and drug accessibility for patients worldwide. The company continues to accelerate the development of diversified and innovative drug pipelines through its strong independent R&D capabilities and external strategic cooperation. The company is committed to comprehensively improving access to medicine for more patients worldwide.

Scope of Service:

-    Site Master Plan

-    Process Design

-    Architectural Design

-    HVAC Design

-    Automation Design

AUSTAR Contribution and Client Benefits:

-    Compliance with the latest GMP regulations (NMPA, EMA, and FDA).

-    Protective measures for high toxicity OEB areas.

-    Applicability of unidirectional flow layout design in high toxicity areas.

-    Flammability/explosiveness risks assessment associated with solvent used in conjugation.

-    Ensure rationality of URS for key process equipment.