---
title: Risk‑Based Contamination Control Strategies for Antibody‑Drug Conjugate (ADC) Drug Substance Manufacturing
description: ADC drug-substance production faces critical cross-contamination risks, but design safeguards and operational controls can minimize pathways and meet cGMP standards.
---

[![BPI Media_Logo 2_Color 1](https://bpi.bioprocessintl.com/hs-fs/hubfs/BPI%20Media_Logo%202_Color%201.png?width=350&height=161&name=BPI%20Media_Logo%202_Color%201.png)](https://bioprocessintl.com/)

# ![BPI Media_AsktheExpert_590 x 197_Header_for_Landing_Pages](https://bpi.bioprocessintl.com/hs-fs/hubfs/BPI%20Media_AsktheExpert_590%20x%20197_Header_for_Landing_Pages.jpg?width=543&height=181&name=BPI%20Media_AsktheExpert_590%20x%20197_Header_for_Landing_Pages.jpg)

# Risk‑Based Contamination

# Control Strategies for Antibody‑Drug

# Conjugate (ADC) Drug Substance Manufacturing

|  |
| --- |

## Presenter:

****![08-13-2026-Samsung-ATE-Speaker-HS-Cropped](https://bpi.bioprocessintl.com/hs-fs/hubfs/08-13-2026-Samsung-ATE-Speaker-HS-Cropped.png?width=160&height=232&name=08-13-2026-Samsung-ATE-Speaker-HS-Cropped.png)****

**Eunseo Ency Lee **  
*Director of New Modality Group,*

Samsung Biologics 

 

Eunseo (Ency) Lee, PhD is the senior scientist of new modality group at Samsung Biologics. After joining Samsung Biologics in 2021, she has led the tech transfer project in both lab- and at-scale mRNA and bioconjugates campaigns. She holds both master's and doctoral degrees in chemical and biological engineering from Seoul National University, South Korea, and a bachelor’s degree in chemical engineering from University of Notre Dame, USA.

## About this event:

#### Date: August 13, 2026

#### Time: 11 AM EDT | 8 AM PDT

#### 5 PM CEST

#### Duration: 30 minutes

| Cross contamination is a critical quality risk in ADC drug‑substance (DS) production because cytotoxic payloads, highly potent reagents, and complex purification steps create multiple pathways for microbial, particulate, and toxic agent ingress. This webcast will present a holistic, risk‑based framework that combines design‑level safeguards with day‑to‑day operational controls to minimize those pathways and meet cGMP expectations. The presentation draws on key considerations for ADC manufacturing in terms of cross contamination, from plant layout and equipment design to personnel practices, raw‑material handling, and cleaning/disinfection procedures. Key design controls include air‑lock flow considering the cytotoxin handling, negative pressure isolator, and the use of single‑use (SU) product‑contact components, which together eliminate the need for extensive cleaning and reduce residual‑material risks. Operational measures such as rigorous personnel training, controlled gowning and hygiene, occupancy limits, and continuous environmental monitoring sustain the integrity of the built‑in safeguards. Key Takeaways: - Risk‑Driven Hazard Identification:  How to map the primary contamination pathways in ADC DS production and assess them with a structured risk‑based approach. - Design‑Based Preventive Measures:  Practical design controls that limit contamination risk, such as plant design, dedicated isolators, and single‑use product‑contact components. - Operational Control Practices: Proven operational strategies, personnel and material flow management, occupancy limits, and cleaning/disinfection to maintain a compliant, low‑risk manufacturing environment. |
| --- |

-  

-  

©2015 BioProcess International All Rights reserved