Our current R&D program within Drug Development is focused on the development of predictive in vitro models aiming at increasing successful outcomes in in vivo settings.
The Bioneer:FARMA R&D group is located at the Department of Pharmacy at University of Copenhagen in Copenhagen and has access to all instruments and technologies essential for the pharmaceutical R&D programs.
Rational Drug Development
In order to circumvent drug canditates failing in clinical trials due to lack of effect or safety issues, Bioneer:FARMA develops in vitro methods to predict the in vivo fate of new therapeutics based upon small chemical entities as well as biologics.
Development of a mechanical dynamic stomach model containing human human gastric lipase.
Bioneer’s Dynamic Gastric Model (DGM) is used to analyze food and drug interactions in the stomach.
Quantitative and qualitative analysis methods to characterize various solid states of APIs.
Development of a novel Blood Brain Barrier model based on human iPS cells.
Use of different drugs in the same formulation.
In collaboration with Danish National Metrology Institute (DFM), Bioneer is developing novel Raman-based spectrometry methods for analysis of small molecules and biologics.
Amorphous Drug Delivery Systems:
Edingera M, Knopp MM, Kerdoncuff H, Rantanen J, Rades T, Löbmann K. (2018) Quantification of microwave-induced amorphization of celecoxib in PVP tablets using transmission Raman spectroscopy. Eur J Pharm Sci 117:62-67 Pubmed
Knopp MM, Nguyen JH, Mu H, Langguth P, Rades T, Holm R. (2016) Influence of Copolymer Composition on In Vitro and In Vivo Performance of Celecoxib-PVP/VA Amorphous Solid Dispersions. AAPS J 18(2):416-23 Pubmed
Sassene PJ, Knopp MM, Hesselkilde JZ, Koradia V, Larsen A, Rades T, Müllertz A. (2010) Precipitation of a poorly soluble model drug during in vitro lipolysis: characterization and dissolution of the precipitate. J Pharm Sci 99(12):4982-91 Pubmed
Saaby L, Helms HC, Brodin B. (2016) IPEC-J2 MDR1, a Novel High-Resistance Cell Line with Functional Expression of Human P-glycoprotein (ABCB1) for Drug Screening Studies. Mol Pharm 13(2):640-52. Pubmed
Ozgür B, Saaby L, Langthaler K, Brodin B. (2018) Characterization of the IPEC-J2 MDR1 (iP-gp) cell line as a tool for identification of P-gp substrates. Eur J Pharm Sci 112:112-121. Pubmed
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