Cleaning Considerations for Antibody Drug Conjugate (ADC) Products
Complimentary
Learning Level: Intermediate
Time: 1000 - 1100 ET
Session Length: 1 hour
Equipment cleaning concerns are often overlooked during design, startup, and commissioning of biopharmaceutical facilities. Failures to understand cleaning agent selection, critical cleaning parameters, drug product degradation, analytical method recovery factors, and stainless-steel maintenance strategy can lead to costly delays in the process.
Technical transfer teams and regulatory agencies expect laboratory testing to support the cleaning validation lifecycle approach. Novel drug products such as antibody drug conjugates (ADC) can present unique cleaning challenges based on the toxicity of the drug and degradation profile of the drug product. This presentation will explore monoclonal antibody (MAb), highly potent active pharmaceutical ingredient (HPAPI) and antibody drug conjugate (ADC) laboratory case studies incorporating routine cleaning evaluation, air-liquid interface residue cleaning strategy, total organic carbon recovery, drug product degradation, and stainless-steel maintenance testing.
Technical transfer teams and regulatory agencies expect laboratory testing and a risk-based strategy to support the cleaning validation lifecycle approach. The cleaning validation strategy of ADC products often encompasses direct, indirect, and non-direct product contact surfaces. This valuable information obtained during the design transfer stage enabled the manufacturing process team to focus on the later stages of cleaning qualification and monitoring.
This presentation will explore cleaning validation and contamination control considerations as applied to ADC products.
Learning Objectives
- Presentation to explore cleaning validation and contamination control considerations as applied to ADC products.
- The cleaning validation strategy of ADC products to cover direct, indirect, and non-direct product contact surfaces.
- Discuss unique cleaning challenges with ADC products including toxicity and active pharmaceutical ingredient (API) degradation.
