Genotoxic Impurities: A Q&A with Amgen's Bo Shen - Pharmaceutical Technology

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Genotoxic Impurities: A Q&A with Amgen's Bo Shen
Genotoxic impurities and how to identify them and control for them have been a concern for several years in the pharmaceutical manufacturing industry. Pharmaceutical Technology spoke with Bo Shen, PhD, principal scientist at Amgen and chair of the AAPS Pharmaceutical Trace Impurities Focus Group, to gain insight on key challenges.

Pharmaceutical Technology
Volume 36, Issue 3, pp. 74-78

Industy's perpsepctive

PharmTech: What has been the role of the AAPS Pharmaceutical Trace Impurities Focus Group for genotoxic impurities on this issue?

Shen: The focus group provides benefits to pharmaceutical scientists by providing a single, broad forum to discuss technical and regulatory topics associated with the impurities, and to better understand at the grassroots level the practices, approaches, and trends used across the industry. Since its inception in 2010, the group has played an influential role on promoting scientific discussion for control and test strategy of genotoxic impurities. In the next few years, the group will continue to focus on highly sensitive analytical methodology development, process development, and genotoxicity tests for impurities/genotoxic impurities that are capable of controlling these impurities.

The group will effectively communicate to establish dialogues among industry, academia, and regulatory groups to discuss technical advances, and understand and apply changes in regulatory viewpoint on impurities/genotoxic impurities. The group will aim to facilitate discussion around science/risk-based regulations and regulatory review practice, and will work to catalyze opportunities to expand targeted academic support and collaborations on topics involving impurities/genotoxic impurities. Overall, the focus group offers a forum for discussion among researchers engaged in basic scientific work in analytical and process chemistry as well as toxicology, and serves as an outlet to connect with members of other sections and focus groups with related interests in the field.

The focus group routinely develops programming proposals in collaboration with other focus groups, such as the AAPS API Focus Group and other industry stakeholders, including the ICH M7 expert working group. For example, the focus group published the first industrial survey results about GTI and is in preparation and conducting a second industry survey on the methodology of the control of the GTIs. The AAPS focus group also organizes educational webinars and events.

These activities reflect the goals of the AAPS focus group, which include to:

  • Establish a core group of interested scientists to explore diverse areas of genotoxic impurities and discuss technical and regulatory issues pertinent to genotoxic impurities
  • Define technical and regulatory genotoxic impurities issues related to development of pharmaceuticals
  • Provide a forum to discuss genotoxic impurities scientific issues and exchange ideas/best practices
  • Organize quality programs for the annual meeting and to conduct workshops on current ICH and FDA and international requirements
  • Provide an avenue for training of new guidance on impurities/genotoxic impurities topics
  • Act as a link among members of industry, academia, and regulators
  • Facilitate workshops/symposia and thereby share experiences and communicate key lessons learned with industry and regulators.

We welcome scientists and regulators to participate in the activities organized by the AAPS Pharmaceutical Trace Impurities Focus Group.


Bo Shen would like to specially thank Dr. Kurt Black, Dr. Ruth Lightfoot–Dunn, Dr. Jerry Murry, Dr. David Semin, and Dr. Sophie Wang for their review and input on this Q&A.


1. FDA, Draft Guidance for Industry: Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches (Rockville, MD 2008).

2. EMA, Guideline on the Limits of Genotoxic Impurities (2006).

3. ICH, M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Concept Paper (2009).


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