Evidence map›Paper›PMID 34452088›Full record

ArticlePharmaceutics2021

Freeze-Dried Mesenchymal Stem Cell-Secretome Pharmaceuticalization: Optimization of Formulation and Manufacturing Process Robustness.

Michela Mocchi, Elia Bari, Giorgio Marrubini, Andrea Foglio Bonda, Sara Perteghella, Fulvio Tartara, Fabio Cofano, Giuseppe di Perna, Lorella Giovannelli, Delia Mandracchia and 4 more

Abstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Michela MocchiDepartment of Drug Sciences, University of Pavia, Viale Taramelli 12, I-27100 Pavia, Italy.ORCID 0000-0002-4565-1718
Elia BariDepartment of Drug Sciences, University of Pavia, Viale Taramelli 12, I-27100 Pavia, Italy.ORCID 0000-0003-0241-0620
Giorgio MarrubiniDepartment of Drug Sciences, University of Pavia, Viale Taramelli 12, I-27100 Pavia, Italy.ORCID 0000-0003-1399-5783
Andrea Foglio BondaDepartment of Pharmaceutical Sciences, University of Piemonte Orientale, Largo Donegani 2/3, I-28100 Novara, Italy.
Sara PerteghellaDepartment of Drug Sciences, University of Pavia, Viale Taramelli 12, I-27100 Pavia, Italy.ORCID 0000-0003-1128-7636
Fulvio TartaraFondazione IRCCS Istituto Neurologico Nazionale Mondino, Via Mondino 2, I-27100 Pavia, Italy.
Fabio CofanoNeuroscience Department "Rita Levi Montalcini" Via Cherasco 15, I-10126 Torino, Italy.
Giuseppe di PernaNeuroscience Department "Rita Levi Montalcini" Via Cherasco 15, I-10126 Torino, Italy.ORCID 0000-0002-7381-9194
Lorella GiovannelliDepartment of Pharmaceutical Sciences, University of Piemonte Orientale, Largo Donegani 2/3, I-28100 Novara, Italy.ORCID 0000-0002-6422-341X
Delia MandracchiaDepartment of Molecular and Translational Medicine, University of Brescia, Viale Europa 11, I-25123 Brescia, Italy.ORCID 0000-0002-7101-013X
Marzio SorliniPharmaExceed S.r.l., Piazza Castello 19, I-27100 Pavia, Italy.
Diego GarbossaNeuroscience Department "Rita Levi Montalcini" Via Cherasco 15, I-10126 Torino, Italy.
Maria Luisa TorreDepartment of Drug Sciences, University of Pavia, Viale Taramelli 12, I-27100 Pavia, Italy.ORCID 0000-0001-8062-6836
Lorena SegaleDepartment of Pharmaceutical Sciences, University of Piemonte Orientale, Largo Donegani 2/3, I-28100 Novara, Italy.ORCID 0000-0003-2331-4339

Funding

Interreg V-A Italy-Switzerland 2014-2020 ATEx-Advanced Therapies Experiences. Project ID 637541.
6 · The paper itself

Abstract

Producing mesenchymal stem cell (MSC)-secretome for dose escalation studies and clinical practice requires scalable and good manufacturing practice (GMP)-compliant production procedures and formulation into a standardized medicinal product. Starting from a method that combines ultrafiltration and freeze-drying to transform MSC-secretome into a pharmaceutical product, the lyosecretome, this work aims to: (i) optimize the lyosecretome formulation; (ii) investigate sources of variability that can affect the robustness of the manufacturing process; (iii) modify the ultrafiltration step to obtain a more standardized final product. Design of experiments and principal component analysis of the data were used to study the influence of batch production, lyophilization, mannitol (M)/sucrose (S) binary mixture, selected as cryoprotectant excipients, and the total amount of excipients on the extracellular vesicles (EV) particle size, the protein and lipid content and the in vitro anti-elastase. The different excipients ratios did not affect residual moisture or EV particle size; simultaneously, proteins and lipids were better preserved in the freeze-dried product using the maximum total concentration of excipients (1.5%

Indexed as

formulationfreeze-dryingmesenchymal stem cellssecretome

Identifiers

PMID34452088
PMCPMC8401234

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.