Proof of concept for a banding scheme to support risk assessments related to multi-product biologics manufacturing

Card, Jeffrey W.; Fikree, Hana; Haighton, Lois A.; Blackwell, James; Felice, B.; Wright, Teresa L.

doi:10.1016/j.yrtph.2015.09.003

Cited by 2 publications

(1 citation statement)

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“…When multiple biologics are produced in a single facility but are not used together as combination drugs, there is the risk of cross-contamination. This risk depends on the type of the drug and can be evaluated using acceptable daily exposure (ADE) values 55 . Recently, Carver proposed a banding scheme to assess the potency or toxicity of biologics; the biologics were categorized according to their toxicity 56 .…”

Section: Discussionmentioning

confidence: 99%

Versatile and on-demand biologics co-production in yeast

et al. 2018

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Current limitations to on-demand drug manufacturing can be addressed by technologies that streamline manufacturing processes. Combining the production of two or more drugs into a single batch could not only be useful for research, clinical studies, and urgent therapies but also effective when combination therapies are needed or where resources are scarce. Here we propose strategies to concurrently produce multiple biologics from yeast in single batches by multiplexing strain development, cell culture, separation, and purification. We demonstrate proof-of-concept for three biologics co-production strategies: (i) inducible expression of multiple biologics and control over the ratio between biologic drugs produced together; (ii) consolidated bioprocessing; and (iii) co-expression and co-purification of a mixture of two monoclonal antibodies. We then use these basic strategies to produce drug mixtures as well as to separate drugs. These strategies offer a diverse array of options for on-demand, flexible, low-cost, and decentralized biomanufacturing applications without the need for specialized equipment.

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Section: Discussionmentioning

confidence: 99%