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Translating the manufacture of immunotherapeutic PLGA nanoparticles from lab to industrial scale: process transfer and in vitro testing
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SYSNO ASEP 0560557 Document Type J - Journal Article R&D Document Type Journal Article Subsidiary J Článek ve WOS Title Translating the manufacture of immunotherapeutic PLGA nanoparticles from lab to industrial scale: process transfer and in vitro testing Author(s) Operti, M. C. (NL)
Bernhardt, A. (DE)
Pots, J. (NL)
Sincari, Vladimir (UMCH-V) ORCID, RID
Jäger, Eliezer (UMCH-V) ORCID, RID
Grimm, S. (DE)
Engel, A. (US)
Benedikt, A. (DE)
Hrubý, Martin (UMCH-V) RID, ORCID
de Vries, I. J. M. (NL)
Figdor, C. G. (NL)
Tagit, O. (NL)Article number 1690 Source Title Pharmaceutics. - : MDPI
Roč. 14, č. 8 (2022)Number of pages 16 s. Language eng - English Country CH - Switzerland Keywords drug delivery ; PLGA ; nanoparticles Subject RIV CD - Macromolecular Chemistry OECD category Polymer science Method of publishing Open access Institutional support UMCH-V - RVO:61389013 UT WOS 000846534000001 EID SCOPUS 85137387690 DOI 10.3390/pharmaceutics14081690 Annotation Poly(lactic-co-glycolic acid) (PLGA) nanoparticle-based drug delivery systems are known to offer a plethora of potential therapeutic benefits. However, challenges related to large-scale manufacturing, such as the difficulty of reproducing complex formulations and high manufacturing costs, hinder their clinical and commercial development. In this context, a reliable manufacturing technique suitable for the scale-up production of nanoformulations without altering efficacy and safety profiles is highly needed. In this paper, we develop an inline sonication process and adapt it to the industrial scale production of immunomodulating PLGA nanovaccines developed using a batch sonication method at the laboratory scale. The investigated formulations contain three distinct synthetic peptides derived from the carcinogenic antigen New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) together with an invariant natural killer T-cell (iNKT) activator, threitolceramide-6 (IMM60). Process parameters were optimized to obtain polymeric nanovaccine formulations with a mean diameter of 150 ± 50 nm and a polydispersity index <0.2. Formulation characteristics, including encapsulation efficiencies, release profiles and in vitro functional and toxicological profiles, are assessed and statistically compared for each formulation. Overall, scale-up formulations obtained by inline sonication method could replicate the colloidal and functional properties of the nanovaccines developed using batch sonication at the laboratory scale. Both types of formulations induced specific T-cell and iNKT cell responses in vitro without any toxicity, highlighting the suitability of the inline sonication method for the continuous scale-up of nanomedicine formulations in terms of efficacy and safety. Workplace Institute of Macromolecular Chemistry Contact Eva Čechová, cechova@imc.cas.cz ; Tel.: 296 809 358 Year of Publishing 2023 Electronic address https://www.mdpi.com/1999-4923/14/8/1690
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