title: Biosafety evaluation of recombinant protein production in goat mammary gland using adenoviral vectors: preliminary study.
abstract: The production of recombinant proteins in the milk of non-transgenic goats can be achieved by transducing the mammary gland with recombinant adenoviral vectors. However, this process involves several regulatory issues. The current study evaluates the biosafety of this production system. We present a preliminary biosafety profile based on detection of adenoviral particles in different body fluids and the antibody response after adenoviral transduction of the goat mammary gland. In addition, two methods of adenoviral inactivation in milk were tested. Although adenoviral particles were detected in the milk until day 4 after transduction, they were absent in serum, saliva, urine and feces. Anti-adenovirus antibodies were detected in serum and milk. The virus inactivation methods neutralized adenoviral particles and preserved the immunological identity of the recombinant protein. These results support the idea of a safe production of recombinant proteins using adenoviral vectors.
authors.affiliation: Animal Biotechnology Department, Center for Genetic Engineering and Biotechnology, Havana, Cuba. elaine.santana@cigb.edu.cu
authors.forename: Elaine Santana
authors.initials: ES
authors.lastname: Rodríguez
authors.forename: Alaín González
authors.initials: AG
authors.lastname: Pose
authors.forename: María Pilar Rodríguez
authors.initials: MP
authors.lastname: Moltó
authors.forename: Angela Sosa
authors.initials: AS
authors.lastname: Espinoza
authors.forename: Pastor Alfonso
authors.initials: PA
authors.lastname: Zamora
authors.forename: Marisela Suárez
authors.initials: MS
authors.lastname: Pedroso
mesh_terms: D000256:Adenoviridae / Q000235:genetics* / Q000302:isolation & purification; D000704:Analysis of Variance; D000818:Animals; D030801:Animals, Genetically Modified; D000914:Antibodies, Viral / Q000032:analysis / Q000097:blood; D001709:Biotechnology / Q000379:methods* / Q000592:standards*; D005260:Female; D005822:Genetic Vectors / Q000235:genetics* / Q000302:isolation & purification; D006041:Goats; D008321:Mammary Glands, Animal / Q000378:metabolism* / Q000821:virology*; D008751:Methylene Blue / Q000737:chemistry; D008892:Milk / Q000276:immunology / Q000821:virology; D011420:Propiolactone / Q000737:chemistry; D011994:Recombinant Proteins / Q000096:biosynthesis* / Q000235:genetics / Q000378:metabolism; D014162:Transfection; D038301:Virus Inactivation
chemical_list: D000914:Antibodies, Viral; D011994:Recombinant Proteins; D011420:Propiolactone; D008751:Methylene Blue