Journal of Pharmaceutical Sciences 111 (2022) 2405

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Journal of Pharmaceutical Sciences

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Editorial

Journal of Pharmaceutical Sciences Topic Cluster on Co-processed

APIs − Call for Papers

We are pleased to announce an upcoming Journal of Pharmaceuti- proceedings, we would like to seek additional contributions with
cal Sciences cluster issue relating to the topic of co-processed APIs. topics including:
A wealth of opportunities to address challenging physical-chemi-
cal properties of active pharmaceutical ingredients (APIs) exist - Case studies where the implementation of co-processed API tech-
through technologies residing at the drug substance-drug product nologies has resulted in an improvement in manufacturing pro-
interface. These technologies involve introduction of non-active com- cess robustness, stability or safe material handling.
ponents (excipients) during drug substance processing to deliver co- - Novel approaches for the preparation or characterization of co-
processed API, which may have promising implications that stand to processed APIs.
transform pharmaceutical manufacturing. - Regulatory and analytical considerations to advance commerciali-
The cluster issue will include perspectives shared at an upcoming zation of co-processed APIs
workshop sponsored by the Food and Drug Administration (FDA) and
the University of Maryland Center for Excellence in Regulatory Sci-
Submissions should be received by October 1, 2022 to enable peer
ence and Innovation (M-CERSI). More details on the workshop can be
reviewing and inclusion in the cluster issue.
found on the event website at https://www.pharmacy.umaryland.
edu/centers/cersievents/co-processed-api/. The workshop will exam-
Declaration of interests
ine recent advances in co-processed APIs as a technology to improve
drug-substance physical-chemical properties and drug product
The authors declare that they have no known competing financial
manufacturing process robustness, and explore proposals for
interests or personal relationships that could have appeared to influ-
enabling commercialization of these transformative technologies.
ence the work reported in this paper.
Regulatory considerations will be also be discussed with a focus on
regulatory classification, regulatory CMC strategies and CMC docu-
mentation supporting the use of this class of materials for clinical Bruno Hancock, Editor
studies and commercialization. Journal of Pharmaceutical Sciences, United States
The cluster issue will be guest edited by Deniz Erdemir (Bristol
Myers Squibb), Steven Ferguson (University College Dublin) and Ivan
Marziano (Pfizer R&D UK), with the initial wave of contributions tar- Received 9 June 2022
geted to be published in late 2022. To complement the workshop Accepted 9 June 2022

https://doi.org/10.1016/j.xphs.2022.06.010
0022-3549/© 2022 Published by Elsevier Inc. on behalf of American Pharmacists Association.