BianoScience


BianoGMP GmbH is a biotech company specializing in oligonucleotide manufacturing, analytics, and GMP services. Founded in 2011 as a spin-off from Friedrich-Schiller-University of Jena, it has developed a therapeutic RNAi platform and expanded its GMP oligonucleotide services. The company is committed to high-quality production for research and clinical applications, supporting projects from early-stage research to later clinical development. It has GMP-certified facilities and collaborates with EUROAPI for large-scale production. The company's mission is to support human health through advanced oligonucleotide solutions.

Industries

biotechnology

Nr. of Employees

small (1-50)

BianoScience

Ronneburger Straße 74, 07546 Gera, Germany


Patents

Biologically active molecules for influencing virus-, bacteria-, parasite-infected cells and/or tumor cells and method for the use thereof

US-9353369-B2

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Biologically active molecules, particularly based on PNA and siRNA, method for the cell-specific activation thereof, and application kit to be administered

US-9347060-B2

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Cell-specifically effective molecules on the basis of siRNA and application kits for the production thereof and use thereof

US-9315808-B2

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Products

Protease-activated RNAi prodrug platform

A therapeutic RNAi prodrug concept consisting of a chimeric siRNA deactivated by a peptide cap that is cleaved by disease-specific proteases to activate the siRNA selectively in diseased tissue; intended for anticancer and antiviral applications.


Services

GMP-compliant manufacture of therapeutic oligonucleotides for early clinical trials, including GMP QC and documentation.

Small- and intermediate-scale oligonucleotide synthesis for R&D, assay development and early-stage projects.

Validated analytical testing and method development for identity, purity, impurity profiling, structural characterization and stability.

Process optimization, scale-up/scale-down, process transfer and process characterization including DOE and process validation services.

Support for ADME/pharmacology studies, dose-range finding, analytical method validation, life-cycle management and design of preclinical/clinical trials.

Project coordination, partner identification for formulation, fill & finish and clinical studies, and cooperative transfer to large-scale CDMO partners for later-phase development.

Expertise Areas

  • Oligonucleotide therapeutics manufacturing
  • Oligonucleotide analytical development
  • GMP manufacturing and quality control
  • Process development and scale-up
  • Show More (4)

Key Technologies

  • Solid-phase oligonucleotide synthesis
  • Automated parallel synthesizers (multi-plate synthesis up to mmol scale)
  • Preparative HPLC
  • Cross-flow (tangential) filtration
  • Show More (6)

News & Updates

BianoGMP's labs are GMP-certified by German authorities for manufacturing and quality control of therapeutic oligonucleotides.


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