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Drug Substance – Small Molecule Impurities Working Group Public Call Response Deadline - 11 February

Drug Substance – Small Molecule Impurities Working Group Public Call Response Deadline - 11 February

January 5, 2022

Background and Rationale 

The small molecule impurities working group is focused on how to treat small molecule portions of antibody-drug conjugates (ADC).  Antibody-drug conjugates (ADCs) are an emerging class of biopharmaceuticals.  As such, there are no specific regulatory guidelines addressing impurity limits and qualification requirements.  The current ICH guidelines on impurities, Q3A (Impurities in New Drug Substances), Q3B (Impurities in New Drug Products) and Q6B (Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products) do not adequately address how to assess small molecule impurities in ADCs.  This working group is applying scientific rational to development a number of positions in this area.

Project Details

The working group is working on multiple issues revolving around small molecule impurities in ADCs.  One issue being addressed is defining the regulatory starting material.  This work will culminate in a white paper on the subject.  Another issue being tackled is an evaluation of the unit operation UF/DF for the removal of small molecule impurities.  A third area of interest is defining aspects of post-approval change.  The group is looking for expertise in these areas.

Qualifications (all are necessary)

Note: Qualifications below must be based upon specific scientific or technical expertise.

Objectives and Boundary of Engagement

The ideal candidate will be responsible for helping to write the regulatory starting material white paper and discuss with the team a position on post-approval changes.

                       
Respondents, please note this is a volunteer role.
When this project is completed, membership with this IQ working group ends. 

 

Please send your statement of interest, including a current CV, by February 11, 2022.