Suzanne M. D’Addio

20 years of Flash NanoPrecipitation – from controlled precipitation to global medicine

Kurt D. Ristroph, Nathalie M. Pinkerton, Chester E. Markwalter, Suzanne M. D’Addio et autres

In the twenty years since the development of Flash NanoPrecipitation (FNP) technology, an antisolvent precipitation technique that uses rapid turbulent mixing to drive self-assembly of polymeric or lipid nanoparticles, the platform has been used for a wide variety of drug delivery applications …

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Review of machine learning for lipid nanoparticle formulation and process development

Phillip James Dorsey, Christina L. Lau, Ti‐chiun Chang, Peter C. Doerschuk et autres

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A Model Study to Assess Fibrillation and Product Stability to Support Peptide Drug Design

Harshil K. Renawala, Karthik Balakrishna Chandrababu, Katelyn J. Smith, Suzanne M. D’Addio et autres

The fibrillation of therapeutic peptides can present significant quality concerns and poses challenges for manufacturing and storage. A fundamental understanding of the mechanisms of fibrillation is critical for the rational design of fibrillation-resistant peptide drugs and can accelerate product development by guiding …

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Probing Molecular Packing of Lipid Nanoparticles from 31P Solution and Solid-State NMR

Ryan V. Schroder, Phillip James Dorsey, Joe Vanderburgh, Wei Xu et autres

Lipid nanoparticles (LNPs) are intricate multicomponent systems widely recognized for their efficient delivery of oligonucleotide cargo to host cells. Gaining insights into the molecular properties of LNPs is crucial for their effective design and characterization. However, analysis of their internal structure at …

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Injectable liposome-containing click hydrogel microparticles for release of macromolecular cargos

Luisa L. Palmese, Paige J. LeValley, Lina Pradhan, Amanda L. Parsons et autres

droplet-based-microfluidics we have established a method for producing click poly-(ethylene)-glycol (PEG)-based microgels with or without chemically crosslinked liposomes (lipo-microgels) through the Michael-type addition reaction between thiol and either vinyl-sulfone or maleimide groups. Unifom spherical microgels and lipo-microgels were generated with sizes of …

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Molecular Mechanism of Antimicrobial Excipient-Induced Aggregation in Parenteral Formulations of Peptide Therapeutics

Mingyue Li, Bradley T. Falk, Xingyu Lu, Ryan V. Schroder et autres

Antimicrobial preservatives are used as functional excipients in multidose formulations of biological therapeutics to destroy or inhibit the growth of microbial contaminants, which may be introduced by repeatedly administering doses. Antimicrobial agents can also induce the biophysical instability of proteins and peptides, …

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Oxetane Promise Delivered: Discovery of Long-Acting IDO1 Inhibitors Suitable for Q3W Oral or Parenteral Dosing

Derun Li, David L. Sloman, Abdelghani Achab, Hua Zhou et autres

3,3-Disubstituted oxetanes have been utilized as bioisosteres for gem-dimethyl and cyclobutane functionalities. We report the discovery of a novel class of oxetane indole-amine 2,3-dioxygenase (IDO1) inhibitors suitable for Q3W (once every 3 weeks) oral and parenteral dosing. A diamide class of IDO …

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Inhibition of N-Nitrosamine Formation in Drug Products: A Model Study

Kausik K. Nanda, Steven E. Tignor, James Clancy, Melanie Marota et autres

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Antimicrobial Excipient-Induced Reversible Association of Therapeutic Peptides in Parenteral Formulations

Suzanne M. D’Addio, Yongchao Su, Dan Yin, Jingtao Zhang et autres

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Chapter 12. Transport, Stability and Delivery Considerations for the Design of Peptide Drugs

Tomi K. Sawyer, Jerome H. Hochman, Suzanne M. D’Addio, Brad S. Sherborne et autres

The biopharmaceutical industry is experiencing renewed interest in the discovery and development of peptide therapeutics, enabled in part by advances in synthetic processes, phage display technologies and combinatorial libraries that have permitted the rapid design, identification and evaluation of potential new peptide …

Chapter 13. Assessing the Impact of Functional Excipients on Peptide Drug Product Attributes During Pharmaceutical Development

Suzanne M. D’Addio, Jameson R. Bothe, Erika Walsh, Marian E. Gindy

Achieving market approval of a new peptide therapeutic requires phase-appropriate demonstration of product safety, efficacy and quality across all stages of development, including raw materials, drug substance and drug product manufacture, product distribution and shelf-life. Of particular importance is the definition of …

Aggregation challenges in the formulation development of multi-dose peptide products

Zhang Jingtao, Katelyn J. Smith, Wei Xu, Yongchao Su et autres