Viral safety of APOSECTM: a novel peripheral blood mononuclear cell derived-biological for regenerative medicine. | Zendy

Alfred Gugerell | Zendy; Dirk Sorgenfrey | Zendy; Maria Laggner | Zendy; J. Raimann | Zendy; Anja Peterbauer | Zendy; Daniel Bormann | Zendy; Susanne Suessner | Zendy; Christian Gabriel | Zendy; Bernhard Moser | Zendy; Tobias Ostler | Zendy; Michael Mildner | Zendy; Hendrik Jan Ankersmit | Zendy

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Viral safety of APOSECTM: a novel peripheral blood mononuclear cell derived-biological for regenerative medicine.

Author(s) -

Alfred Gugerell,

Dirk Sorgenfrey,

Maria Laggner,

J. Raimann,

Anja Peterbauer,

Daniel Bormann,

Susanne Suessner,

Christian Gabriel,

Bernhard Moser,

Tobias Ostler,

Michael Mildner,

Hendrik Jan Ankersmit

Publication year - 2020

Publication title -

vox sanguinis

Language(s) - English

Resource type - Journals

eISSN - 1423-0410

pISSN - 0042-9007

DOI - 10.2450/2019.0249-18

Subject(s) - infectivity , virology , pseudorabies , virus , porcine parvovirus , viral envelope , peripheral blood mononuclear cell , biology , in vitro , biochemistry

Viral reduction and inactivation of cell-derived biologicals is paramount for patients' safety and so viral reduction needs to be demonstrated to regulatory bodies in order to obtain marketing authorisation. Allogeneic human blood-derived biological medicinal products require special attention. APOSEC TM , the secretome harvested from selected human blood cells, is a new biological with promising regenerative capabilities. We evaluated the effectiveness of inactivation of model viruses by methylene blue/light treatment, lyophilisation, and gamma irradiation during the manufacturing process of APOSEC TM .

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