Scale up of proteoliposome derived Cochleate production

Zayas, Caridad; Bracho, Gustavo; Lastre, Miriam; González, Domingo; Gil, Danay; Acevedo, Reinaldo; Campo, Judith del; Taboada, Carlos; Solís, Rosa L.; Barberá, Ramón; Pérez, Oliver

doi:10.1016/j.vaccine.2005.01.139

Cited by 10 publications

(9 citation statements)

References 2 publications

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“…Recently, the efficacy and optimization of scale‐up production of proteoliposome‐derived cochleate delivery systems containing different antigens for intranasal immunization of Balb/c mice were evaluated in a series of studies. Proteoliposome derived cochleates are prepared to combine adjuvant properties of proteoliposomes with stability of cochleates that make the delivery system capable of inducing both systemic and mucosal antibody as well as Th1 type of immunity by intranasal immunization 132, 142–145. However, the toxicity of proteoliposome derived cochleates is yet to be fully evaluated in humans.…”

Section: Particulate Systems For Intranasal Vaccine Deliverymentioning

confidence: 99%

Pharmaceutical Aspects of Intranasal Delivery of Vaccines Using Particulate Systems

Sharma

Mukkur

Benson

et al. 2009

Journal of Pharmaceutical Sciences

146

137

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Section: Particulate Systems For Intranasal Vaccine Deliverymentioning

confidence: 99%

Pharmaceutical Aspects of Intranasal Delivery of Vaccines Using Particulate Systems

Sharma

Mukkur

Benson

et al. 2009

Journal of Pharmaceutical Sciences

146

137

View full text Add to dashboard Cite

“…As CFA is too toxic for human use, as part of the development program for MSP4 and MSP5 as malaria vaccine candidates various adjuvants have been tested for their suitability for inclusion in clinical trials of these vaccines. The development of a novel adjuvant based on the structural transformation into cochleate structures (AFCo1, Adjuvant Finlay Cochleate 1) of proteoliposomes (PL) extracted from the outer membrane of Neisseria meningitidis B has been previously reported [ 32 , 33 ]. AFCo1 consists of a highly stable complex of Ca2+, proteins and lipids forming a compact multilayered tubular structure, which can accommodate new antigens from different sources thus allowing its use as an antigen delivery system [ 32 , 34 , 35 ].…”

Section: Introductionmentioning

confidence: 99%

AFCo1, a meningococcal B-derived cochleate adjuvant, strongly enhances antibody and T-cell immunity against Plasmodium falciparum merozoite surface protein 4 and 5

Bracho

Zayas

Wang

et al. 2009

Malar J

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Background: Whilst a large number of malaria antigens are being tested as candidate malaria vaccines, a major barrier to the development of an effective vaccine is the lack of a suitable human adjuvant capable of inducing a strong and long lasting immune response. In this study, the ability of AFCo1, a potent T and B cell adjuvant based on cochleate structures derived from meningococcal B outer membrane proteoliposomes (MBOMP), to boost the immune response against two Plasmodium falciparum antigens, merozoite surface protein 4 (MSP4) and 5 (MSP5), was evaluated.

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“…Previous studies have demonstrated the production of AFCo1 on a lab scale and preliminary work at higher scale demonstrated that CFS could be used to obtain larger amounts of cochleates [4]. …”

Section: Discussionmentioning

confidence: 99%

“…Cochleate structures were obtained from these proteoliposomes [4]. Briefly, AFCo1 formation was performed by diluting precipitated proteoliposomes with detergent.…”

Section: Methodsmentioning

confidence: 99%

Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B

et al. 2013

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The use of new adjuvants in vaccine formulations is a subject of current research. Only few parenteral adjuvants have been licensed. We have developed a mucosal and parenteral adjuvant known as AFCo1 (Adjuvant Finlay Cochleate 1, derived from proteoliposomes of N. meningitidis B) using a dialysis procedure to produce them on lab scale. The immunogenicity of the AFCo1 produced by dialysis has been already evaluated, but it was necessary to demonstrate the feasibility of a larger-scale manufacturing process. Therefore, we used a crossflow diafiltration system (CFS) that allows easy scale up to obtain large batches in an aseptic environment. The aim of this work was to produce AFCo1 on pilot scale, while conserving the adjuvant properties. The proteoliposomes (raw material) were resuspended in a buffer containing sodium deoxycholate and were transformed into AFCo1 under the action of a calcium forming buffer. The detergent was removed from the protein solution by diafiltration to a constant volume. In this CFS, we used a hollow fiber cartridge from Amicon (polysulfona cartridge of 10 kDa porosity, 1mm channel diameter of fiber and 0.45 m2 area of filtration), allowing production of a batch of up to 20 L. AFCo1 were successfully produced by tangential filtration to pilot scale. The batch passed preliminary stability tests. Nasal immunization of BALB/c mice, induced specific saliva IgA and serum IgG. The induction of Th1 responses were demonstrated by the induction of IgG2a, IFNγ and not IL-5. The adjuvant action over Neisseria (self) antigens and with co-administered (heterologous) antigens such as ovalbumin and a synthetic peptide from haemolytic Streptococcus B was also demonstrated.

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Scale up of proteoliposome derived Cochleate production

Cited by 10 publications

References 2 publications

Pharmaceutical Aspects of Intranasal Delivery of Vaccines Using Particulate Systems

Pharmaceutical Aspects of Intranasal Delivery of Vaccines Using Particulate Systems

AFCo1, a meningococcal B-derived cochleate adjuvant, strongly enhances antibody and T-cell immunity against Plasmodium falciparum merozoite surface protein 4 and 5

Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B

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