Summary report of PQRI workshop on nanomaterial in drug products: current experience and management of potential risks
Open accessAbstract
At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.
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The high complexity of nanoscale drugs can make complete physicochemical characterization a significant challenge, especially for follow-on or generic formulations.
“This high degree of complexity can make complete physicochemical characterization a significant challenge, especially for follow-on or generic formulations, which has also been addressed at different levels both by the NCL (USA) and European Pharmacopoeia [293, 299]”
From Polymeric micelles for the delivery of poorly soluble drugs: From nanoformulation to clinical approval. (2020) · cites this paper as [299]
The Session II characterization discussion says that nanodrug diversity makes characterization complex and that there is debate about how to characterize nanomaterials fully. The discussion of follow-on “nanosimilars” says they require stepwise comparability studies, but does not say that complete physicochemical characterization is especially challenging for them. The supplied passages have no page numbers. (LLM, conf=0.84)
Experimental — accuracy not yet measuredA nanosimilar formulation must show comparable character at each step and cannot rely on in vitro or preclinical animal model data alone, making some level of clinical evaluation necessary.
“The nanosimilar formulation must show comparable character at each step of the process and cannot rely on in vitro or preclinical animal model data alone, making a case for having some level of clinical evaluation to be necessary for nanosimilars.”
From Polymeric micelles for the delivery of poorly soluble drugs: From nanoformulation to clinical approval. (2020) · cites this paper as [299]
The section on the EMA’s evaluation of nanosimilars says that demonstrating similarity in quality, safety, and efficacy requires stepwise comparability studies. It does not say that in vitro and preclinical animal data are necessarily insufficient or that clinical evaluation is required for nanosimilars. The “Versus Development Timeline” section describes exploratory human trials in some cases, but not as a requirement for nanosimilars; page numbers were unavailable in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe EMA has developed a stepwise nanosimilar approval route including in vitro quality assessments, preclinical biodistribution, clinical PK, and therapeutic equivalence.
“For the approval of nanosimilars, the EMA follows a stepwise approach [293, 299] which includes in vitro quality assessments, pre-clinical biodistribution, clinical PK, and then therapeutic equivalence.”
From Polymeric micelles for the delivery of poorly soluble drugs: From nanoformulation to clinical approval. (2020) · cites this paper as [299]
The section on EMA regulation of nanosimilars (page unavailable) says that demonstrating similarity in quality, safety, and efficacy requires stepwise comparability studies. It does not specify the claimed sequence of in vitro quality assessment, preclinical biodistribution, clinical PK, and therapeutic equivalence, or describe it as a developed approval route. (LLM, conf=0.87)
Experimental — accuracy not yet measured
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“This high degree of complexity canmake complete physicochemical characterization a significant challenge, especially for follow-on or generic formulations, which has also been addressed at different levels both by the NCL (USA) and European Pharmacopoeia [293,299].”
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Papaluca, M., Ehmann, F., Pita, R., & Hernan, D. (2016) · Wiley eBooks · doi:10.1002/9783527800681.ch20 · Cited by 3 · see citing works
Sheng, J., Wu, L., Ding, H., Zhang, Y., & Gu, N. (2023) · Micro/Nano technologies · doi:10.1007/978-981-16-8984-0_22 · Cited by 1 · see citing works
Nano‐Exposure Science: How Does Exposure to Engineered Nanomaterials Happen?
Sayes, C. M., & Aquino, G. V. (2017) · doi:10.1002/9783527800308.ch22
Self-citationPerspectives for Characterizing Drug Component of Theranostic Products Containing Nanomaterials
Sayes, C. M., & Hickey, A. J. (2018) · Bioanalysis · doi:10.1007/978-3-030-01775-0_13
Self-citationPreclinical characterization of PEGASEMP™ nanomedicine and regulatory framework
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(2024) · International Journal of Biology Pharmacy and Allied Sciences · doi:10.31032/ijbpas/2024/13.8.8271
- Authors
- Bartlett, J. A., Brewster, M., Brown, P., Cabral-Lilly, D., Cruz, C. N., David, R., Eickhoff, W. M., Haubenreisser, S., Jacobs, A., Malinoski, F., Morefield, E., Nalubola, R., Prud’homme, R. K., Sadrieh, N., Sayes, C. M., Shahbazian, H., Subbarao, N., Tamarkin, L., Tyner, K., Uppoor, R., Whittaker-Caulk, M., & Zamboni, W.
- Affiliations
- Pfizer (United States) (US)
- Janssen (Belgium) (BE)
- United States Food and Drug Administration (US)
- BASF (United States) (US)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- European Medicines Agency (NL)
- Vertex Pharmaceuticals (United States) (US)
- Princeton University (US)
- Center for Food Safety and Applied Nutrition (US)
- RTI International (US)
- Health Canada (CA)
- CytImmune (United States) (US)
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Cruz, Celia N.
- ORCID
- Venue
- The AAPS Journal
- Published
- 2014-11-25
- Volume
- 17
- Issue
- 1
- Pages
- 44-64
- ISSN
- 1550-7416 (ISSN-L)
- PMC
- PMC4287304
- OpenAlex
- W2041870189
- Cited by
- 25
- References
- 65
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 1 · 2022: 2 · 2021: 2 · 2020: 1 · 2019: 3 · 2018: 4 · 2017: 4 · 2016: 5 · 2015: 1
- FWCI
- 1.26
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- public-domain
- www.springer.com/tdm (tdm)
- Locations
- The AAPS Journal (publishedVersion, public-domain)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion, public-domain)
- UNC Libraries
- Funders
- University of Pennsylvania
- U.S. Food and Drug Administration
- Topics
- Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
- Physical Sciences › Engineering › Biomedical Engineering › Nanotechnology research and applications
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Keywords
- nanomedicine, nanomedicine regulation, nonclinical safety evaluation, nanomaterial characterization, regulatory guidelines, Health Canada, European Medicines Agency, nanomaterial manufacturing
- MeSH terms
- Animals, Chemistry, Pharmaceutical, Drug and Narcotic Control, Pharmaceutical Preparations, Humans, Tissue Distribution, Drug Design, Drug Approval, Nanostructures, Nanoparticles
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