Special Topic Cluster: Deniz Erdemir, Bristol Myers Squibb, USA, Steven Ferguson, University College Dublin, Ireland, Ivan Marziano, Pfizer R&D, UK, Bruno Hancock, JPharmSci, USA.
This cluster issue is centered around the proceedings from a 2-day workshop 1 held in July 2022 sponsored by the Food and Drug Administration (FDA) and the University of Maryland Centred for Excellence in Regulatory Science and Innovation (M-CERSI). The workshop explored recent advances in co-processed APIs and discussed options for commercializing these transformative technologies. Regulatory considerations were discussed with a focus on classification and CMC (Chemistry, Manufacturing, and Controls) documentation needed to support the use of co-processed APIs in clinical studies and commercial products.
In addition to the workshop proceedings, research papers from the participants of the workshop are included in this cluster issue, alongside contributions from prominent researchers in this field. The papers include several case studies where the implementation of co-processed API technologies has resulted in an improvement in manufacturing process robustness, stability, or safe material handling, and provide an important practical illustration of the benefits associated with this technology. Novel approaches for the preparation or characterization of co-processed APIs are also described in several papers.
The authors hope that this cluster issue prompts both further research into, and further discussion of the novel technologies available for producing medicines using co-processed API. We also hope that it spurs the development of new regulatory pathways for the approval of medicines that could not be otherwise be brought to patients.
Link and option to download full issue here
See below, two papers featuring SSPC investigators and researchers Steven Ferguson, Michael Stocker, University College Dublin, Prof. Anne Marie Healy, Monika Myślińska and Evangelia Tsolakia, Trinity College Dublin, Ireland.
A Comparison of Spray-Drying and Co-Precipitation for the Generation of Amorphous Solid Dispersions (ASDs) of Hydrochlorothiazide and Simvastati, Monika Myślińska, Michael W. Stocker, Steven Ferguson, Anne Marie Healy, (2023)
School of Pharmacy and Pharmaceutical Sciences, Panoz Institute, Trinity College Dublin, Dublin 2, Ireland. School of Chemical and Bioprocess Engineering, University College Dublin, Dublin 4, Ireland. SSPC, The Science Foundation Ireland Research Centre for Pharmaceuticals, Ireland. EPSRC-SFI Centre for Doctoral Training in Transformative Pharmaceutical Technologies, Ireland. I-Form, The SFI Research Centre for Advanced Manufacturing, School of Chemical and Bioprocess Engineering, University College Dublin, Dublin 4, Ireland. National Institute for Bioprocess Research and Training, Dublin, Ireland.
Combining Isolation-Free and Co-Processing Manufacturing Approaches to Access Room Temperature Ionic Liquid Forms of APIs, Michael W. Stocker, Evangelia Tsolakia, Matthew J. Harding, Anne Marie Healy, Steven Ferguson, (2023).
SSPC, The SFI Research Centre for Pharmaceuticals, School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, D04 V1W8, Ireland. EPSRC-SFI Centre for Doctoral Training in Transformative Pharmaceutical Technologies, Ireland
I-Form, The SFI Research Centre for Advanced Manufacturing, School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, D04 V1W8, Ireland. School of Pharmacy and Pharmaceutical Sciences, Panoz Institute, Trinity College Dublin, D02
PN40 Dublin, Ireland. National Institute for Bioprocess Research and Training, 24 Foster Avenue, Blackrock, Co., Belfield, A94 X099 Dublin, Ireland
