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Drug-Drug Interaction Assessment for Therapeutic Proteins; Draft Guidance

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guay   Monday, 08/24/20 06:23:04 PM
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Drug-Drug Interaction Assessment for Therapeutic Proteins; Draft Guidance for Industry; Availability
https://beta.regulations.gov/document/FDA-2020-D-1480-0004

FDA-2020-D-1480 Includes Therapeutic Proteins in IBIO-CBFO3

iBio Introduces FastGlycaneering Development Service™ to Power Recombinant Protein Production

Quote:
“The protein expression technologies covered by this patent have particular utility for companies interested in producing proteins in plant cell culture,” explained iBio’s vice president of intellectual property, Wayne P. Fitzmaurice, Ph.D. “Current strategies for expression of proteins in plants typically use whole plants grown in controlled environmental chambers or plant cell culture in a bioreactor. iBio has multiple proprietary systems enabling us and our clients to select the most efficient technology for a specific biopharmaceutical depending on its characteristics and commercial applications.”

The other allowed patent application involves the company’s “System for Expression of Genes in Plants,” which is a system that uses methods of expressing one or more polynucleotides of interest with resources to a set of plant viral vectors that work together. Polynucleotides of interest include encoding therapeutic proteins, antibody chains, nutritionally relevant proteins, and polynucleotides that provide a template for transcription of an active RNA species, among others.

“These allowances are important additions to our broad patent coverage of innovative technologies for development and production of biopharmaceuticals,” said the president of iBio, Robert Erwin. “Our iBioLaunch platform technology is well suited for vaccines, antibodies and other therapeutic proteins. We expect increasing commercial interest in its numerous applications, in particular, our proprietary fibrosis product, and prevention and treatment of infectious disease outbreaks.”

The applications are part of the research performed by iBio’s scientists in collaboration with the technology collaborator, the Fraunhofer USA Center for Molecular Biotechnology.

Source: https://pulmonaryfibrosisnews.com/2014/08/29/ibios-protein-expression-technology-granted-two-european-patent-allowances/



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