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Advanced Therapeutics
Article . 2020 . Peer-reviewed
License: Wiley Online Library User Agreement
Data sources: Crossref
UNC Dataverse
Article . 2021
Data sources: Datacite
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Batch Culture Formulation of Live Biotherapeutic Products

Authors: Kunyu Qiu; Aaron C. Anselmo;

Batch Culture Formulation of Live Biotherapeutic Products

Abstract

AbstractLive biotherapeutic products (LBPs) are an emerging therapeutic modality that have been clinically investigated for treating pathogenic infections and inflammatory diseases. A major class of LBPs are feces‐derived microbial consortiums which require numerous process development steps (e.g., separation, purification, blending) to facilitate LBP formulation into oral dosage forms. A subset of these LBPs circumvents the need for continuous fecal processing by batch culture for individual strains of microbes that are rationally defined and combined in the final LBP formulation. Separately, delivery formulations (e.g., polymer encapsulation) are being developed for LBPs to improve storage and intestinal engraftment; however, formulation requires additional manufacturing processes distinct from fecal processing or batch culture. Here, a streamlined approach termed batch culture formulation (BCF) is developed to combine the individual batch culture and formulation processes into a single‐step process. Based on a previously described polymeric film formulation that encapsulates LBPs, BCF is shown to reduce the number of required processes to formulate LBP‐films without altering LBP phenotype, function, or storage profiles compared to the standard LBP‐film formulation approach. Additionally, it is demonstrated that BCF facilitates scaled‐fabrication from the milligram to gram scale with predictable loading, highlighting the potential that BCF has for clinical translation.

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    3
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
3
Average
Average
Average
bronze