Cumulative updating of approved biopharmaceuticals dating during a marriage separation
The entering into the market of a progressively increasing number of protein drugs produced in non-microbial systems has not impaired the development of products obtained in microbial cells, proving the robustness of the microbial set of cellular systems (so far Escherichia coli and Saccharomyces cerevisae) developed for protein drug production.
We summarize here the nature, properties and applications of all those pharmaceuticals and the relevant features of the current and potential producing hosts, in a comparative way.
There are many ever-evolving guidance documents available globally to broadly indicate equivalence and chemically and biologically control the development and commercialization of products.
Rather, Cyt Rx's completed pharmacokinetic clinical trial, Phase 2b and Phase 3 trials in STS, along with preclinical safety and efficacy studies, will serve as "scientific bridges" between aldoxorubicin and doxorubicin.
These studies, along with the published literature of doxorubicin's effectiveness and safety, will form the basis of the NDA filing for aldoxorubicin under the 505(b)(2) regulations.
Most of the hosts used to produce the 151 recombinant pharmaceuticals so far approved for human use by the Food and Drug Administration (FDA) and/or by the European Medicines Agency (EMEA) are microbial cells, either bacteria or yeast.
This fact indicates that despite the diverse bottlenecks and obstacles that microbial systems pose to the efficient production of functional mammalian proteins, namely lack or unconventional post-translational modifications, proteolytic instability, poor solubility and activation of cell stress responses, among others, they represent convenient and powerful tools for recombinant protein production.