About: Simian adenovirus vector production for early-phase clinical trials: A simple method applicable to multiple serotypes and using entirely disposable product-contact components

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About: Simian adenovirus vector production for early-phase clinical trials: A simple method applicable to multiple serotypes and using entirely disposable product-contact components Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Simian adenovirus vector production for early-phase clinical trials: A simple method applicable to multiple serotypes and using entirely disposable product-contact components
Creator	Wright, Daniel Morris, Susan Gilbert, Sarah Merritt, Thomas Warimwe, George Angell-Manning, Phillip Boumlic, Anissa Fedosyuk, Sofiya Kangokar, Anilkumar Lam, Ada Laroudie, Nicolas Xenopoulos, Alex Douglas, Alexander Polo Peralta-Alvarez, Marco Ritchie, Adam
Source	Elsevier; Medline; PMC
abstract	A variety of Good Manufacturing Practice (GMP) compliant processes have been reported for production of non-replicating adenovirus vectors, but important challenges remain. Most clinical development of adenovirus vectors now uses simian adenoviruses or rare human serotypes, whereas reported manufacturing processes mainly use serotypes such as AdHu5 which are of questionable relevance for clinical vaccine development. Many clinically relevant vaccine transgenes interfere with adenovirus replication, whereas most reported process development uses selected antigens or even model transgenes such as fluorescent proteins which cause little such interference. Processes are typically developed for a single adenovirus serotype – transgene combination, requiring extensive further optimization for each new vaccine. There is a need for rapid production platforms for small GMP batches of non-replicating adenovirus vectors for early-phase vaccine trials, particularly in preparation for response to emerging pathogen outbreaks. Such platforms must be robust to variation in the transgene, and ideally also capable of producing adenoviruses of more than one serotype. It is also highly desirable for such processes to be readily implemented in new facilities using commercially available single-use materials, avoiding the need for development of bespoke tools or cleaning validation, and for them to be readily scalable for later-stage studies. Here we report the development of such a process, using single-use stirred-tank bioreactors, a transgene-repressing HEK293 cell – promoter combination, and fully single-use filtration and ion exchange components. We demonstrate applicability of the process to candidate vaccines against rabies, malaria and Rift Valley fever, each based on a different adenovirus serotype. We compare performance of a range of commercially available ion exchange media, including what we believe to be the first published use of a novel media for adenovirus purification (NatriFlo® HD-Q, Merck). We demonstrate the need for minimal process individualization for each vaccine, and that the product fulfils regulatory quality expectations. Cell-specific yields are at the upper end of those previously reported in the literature, and volumetric yields are in the range 1 × 10(13) – 5 × 10(13) purified virus particles per litre of culture, such that a 2–4 L process is comfortably adequate to produce vaccine for early-phase trials. The process is readily transferable to any GMP facility with the capability for mammalian cell culture and aseptic filling of sterile products.
has issue date	2019-11-08(xsd:dateTime)
bibo:doi	10.1016/j.vaccine.2019.04.056
bibo:pmid	31047679
has license	cc-by
sha1sum (hex)	e724e9c56dedc9430663c4eb447b1b0ec08133e6
schema:url	https://doi.org/10.1016/j.vaccine.2019.04.056
resource representing a document's title	Simian adenovirus vector production for early-phase clinical trials: A simple method applicable to multiple serotypes and using entirely disposable product-contact components
has PubMed Central identifier	PMC6949866
has PubMed identifier	31047679
schema:publication	Vaccine
resource representing a document's body	covid:e724e9c56dedc9430663c4eb447b1b0ec08133e6#body_text
is schema:about of	named entity 'Good Manufacturing Practice (GMP)' named entity 'selected' named entity 'development' named entity 'vaccine' named entity 'ADENOVIRUS VECTOR' named entity 'VACCINE' named entity 'DEVELOPMENT' named entity 'COMPLIANT' named entity 'COMBINATION' named entity 'TRANSGENE' named entity 'BUT' named entity 'SINGLE' named entity 'PRODUCT' named entity 'SIMPLE' named entity 'COMPONENTS' named entity 'PRODUCTION' named entity 'PROCESS' named entity 'USE' named entity 'OPTIMIZATION' named entity 'MANUFACTURING PROCESSES' named entity 'MODEL' named entity 'SEROTYPES' named entity 'HAVE' named entity 'CONTACT' named entity 'USING' named entity 'PHASE' named entity 'INTERFERE' named entity 'NON-' named entity 'CAUSE' named entity 'EXTENSIVE' named entity 'EARLY' named entity 'PRODUCTION' named entity 'MULTIPLE' named entity 'CLINICAL TRIALS' named entity 'SEROTYPES' named entity 'SIMIAN ADENOVIRUS' named entity 'LITTLE' named entity 'ADENOVIRUS SEROTYPE' named entity 'FLUORESCENT' named entity 'ADENOVIRUSES' named entity 'SELECTED' named entity 'ADENOVIRUS' named entity 'CHALLENGES' named entity 'REPORTED' named entity 'VARIETY' named entity 'HUMAN' named entity 'GOOD MANUFACTURING PRACTICE' named entity 'PROCESSES' named entity 'INTERFERENCE' named entity 'RELEVANT' named entity 'USES' named entity 'PROTEINS' named entity 'ANTIGENS' named entity 'RELEVANCE' named entity 'REPLICATION' named entity 'REPLICATING' named entity 'SIMIAN' named entity 'VACCINE DEVELOPMENT' named entity 'VECTORS' named entity 'CLINICAL' named entity 'IMPORTANT' named entity 'METHOD' named entity 'NEW' named entity 'QUESTIONABLE' named entity 'DISPOSABLE' named entity 'APPLICABLE' named entity 'TRANSGENES'

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