Biosafety evaluation of recombinant protein production in goat mammary gland using adenoviral vectors: Preliminary study

Jiménez, Efraín Rodríguez; Pose, Alaín González; Moltó, María Pilar Rodríguez; Espinoza, Angela Sosa; Alfonso, P; Pedroso, Marisela Suárez

doi:10.1002/biot.201100455

Cited by 6 publications

(3 citation statements)

References 17 publications

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“…The combination of methylene blue and white light irradiation effectively inactivated the Ad-E2 vector initially present in the first samples of milk collected. With this approach, the use of inactivating agents such as the potentially toxic beta-propiolactone was avoided, in contrast with other procedures previously proposed (25,26).…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of the E2-Classical Swine Fever Virus Recombinant Vaccine Produced and Formulated within Whey from Genetically Transformed Goats

Sánchez¹,

Barrera²,

Farnós³

et al. 2014

Clin. Vaccine Immunol.

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e Subunit recombinant vaccines against classical swine fever virus (CSFV) are a promising alternative to overcome practical and biosafety issues with inactivated vaccines. One of the strategies in evaluation under field conditions is the use of a new marker E2-based vaccine produced in the milk of adenovirally transduced goats. Previously we had demonstrated the efficacy of this antigen, which conferred early protection and long-lasting immunity in swine against CSFV infection. Here, we have used a simpler downstream process to obtain and formulate the recombinant E2 glycoprotein expressed in the mammary gland. The expression levels reached approximately 1.7 mg/ml, and instead of chromatographic separation of the antigen, we utilized a clarification process that eliminates the fat content, retains a minor amount of caseins, and includes an adenoviral inactivation step that improves the biosafety of the final formulation. In a vaccination and challenge experiment in swine, different doses of the E2 antigen contained within the clarified whey generated an effective immune response of neutralizing antibodies that protected all of the animals against a lethal challenge with CSFV. During the immunization and after challenge, the swine were monitored for adverse reactions related to the vaccine or symptoms of CSF, respectively. No adverse reactions or clinical signs of disease were observed in vaccinated animals, in which no replication of CSFV could be detected after challenge. Overall, we consider that the simplicity of the procedures proposed here is a further step toward the introduction and implementation of a commercial subunit vaccine against CSF.

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Section: Discussionmentioning

confidence: 99%

Effectiveness of the E2-Classical Swine Fever Virus Recombinant Vaccine Produced and Formulated within Whey from Genetically Transformed Goats

Sánchez¹,

Barrera²,

Farnós³

et al. 2014

Clin. Vaccine Immunol.

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“…54,84,85 The dAd5GNE vaccine is comprised of the GNE hapten (Figure 3) covalently linked to the proteins of a serotype 5 adenovirus (Ad5) disrupted to expose additional sites for GNE conjugation and co-administered with Adjuplex, a biodegradable matrix of carbomer homopolymer (cross-linked polyacrylic acids) and nanoliposomes derived from purified soy lecithin. The adenovirus has a favorable safety profile, demonstrated in clinical studies, 86 and was shown to stimulate a strong immune response when covalently conjugated to the cocaine analogue. 54,85 Pre-clinical assessment of the dAd5GNE vaccine demonstrated high titers of anti-GNE antibodies which blocked cocaine from reaching the central nervous system of mice, rats, and nonhuman primates.…”

Section: Clinical Advances In Anti-cocainementioning

confidence: 99%

Anti-cocaine Vaccine Development: Where Are We Now and Where Are We Going?

Stephenson

Tóth

2023

J. Med. Chem.

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Cocaine is one of the oldest and most widely used illicit drugs in the world and is responsible for major worldwide medical and social problems. Drug addiction is a disease state where the body relies on a substance for normal functioning and develops a physical dependence leading to compulsive and repetitive use despite negative consequences to the user's health, mental state, or social life. The primary driver for the development of anti-cocaine vaccines has been the failure to develop effective pharmacological treatments to combat cocaine dependence. Despite several decades of research, no approved pharmacological treatments for cocaine dependence are available to assist addicts to overcome cocaine withdrawal or to prevent drug relapse. This Perspective highlights the challenges associated with anti-cocaine vaccines, including the current state of anti-cocaine vaccines and catalytic antibody research to aid in the fight against cocaine addiction.

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“… 7 Therefore, adenovirus is frequently used for the gene therapy-based clinical trials to treat several diseases, such as cancers, cardiovascular diseases, central nervous system diseases, infectious diseases, etc. 8 , 9 , 10 , 11 , 12 …”

Section: Introductionmentioning

confidence: 99%

The Effect of Residual Triton X-100 on Structural Stability and Infection Activity of Adenovirus Particles

et al. 2020

Molecular Therapy - Methods & Clinical Development

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To ensure the high purity and biological activity of the adenovirus vector to be used for clinical applications, a stable and linearly scalable preparation method is highly imperative. During the adenovirus-harvesting process, the Triton X-100-based lysis method possesses the advantages of higher efficiency as well as easier linearization and amplification. Most Triton X-100 can be removed from the adenovirus sample by chromatographic purification. However, there is no report that a small amount of residual Triton X-100, present in adenovirus sample, can affect the particle integrity, infectivity, and structure of adenoviruses. Here, we found that although residual Triton X-100 affected the short-term stability, purity, infectivity, and structure of adenoviruses at 37°C, it did not hamper these properties of adenoviruses at 4°C. This study suggests that although the Triton X-100-based lysis method is a simple, efficient, and easy-to-scale process for lysing host cells to release the adenovirus, the storage conditions of adenovirus products must be taken into consideration.

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Biosafety evaluation of recombinant protein production in goat mammary gland using adenoviral vectors: Preliminary study

Cited by 6 publications

References 17 publications

Effectiveness of the E2-Classical Swine Fever Virus Recombinant Vaccine Produced and Formulated within Whey from Genetically Transformed Goats

Effectiveness of the E2-Classical Swine Fever Virus Recombinant Vaccine Produced and Formulated within Whey from Genetically Transformed Goats

Anti-cocaine Vaccine Development: Where Are We Now and Where Are We Going?

The Effect of Residual Triton X-100 on Structural Stability and Infection Activity of Adenovirus Particles

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