in vitro models of Synthesis of API biological barriers ...€¦ · 7/11/2017 · veral decades of...
1
GMP Pharmaceutical formulations & Nanoformulation GMP-Analytics of Peptides, Proteins, small molecules & finished drugs Generation of libraries (CombiChem) MedChem in vitro models of biological barriers Synthesis of API and excipients in small batches Drug Delivery/Biological Barriers Biological Barriers Lung Upper airways & deep lung Particle deposition devices Skin Human & porcine skin Permeation experiments Penetration experiments Intestine Healthy and inflamed state Combined dissolution Drug Delivery Development of pharmaceutical formulations Nanomedicine Drug Delivery systems Non invasive analytical techniques (Confocal Raman microscopy) Analytics GMP certified according to §14 AMG Analytics of APIs and finished drugs Characterisation of biopharmaceuticals Development of methods Validation of methods (ICH, ECP) Techniques HP- liquid chromatography - hrMS HPLC - DAD / - UV Capillary electrophoresis (CE), CE - hr MS Calorimetry (DSC) Karl- Fischer water determination Gel electrophoresis (CE-SDS, SDS-PAGE, IEF & native PAGE) Western Blotting and ELISA Protein identification Particle characterization Stability test according to CPMP/ICH/2736/99 (Q1A) Photostability test according to CMPM/ICH/279/95 (Q1B) Drug Discovery & Synthesis Medicinal Chemistry Combinatorial Chemistry Organic synthesis Establishing of structure activity relationships Optimization of hits and leads Surface Plasmon Resonance (SPR) spectroscopy Detection and quantification of Small Molecules in biological matrices (for Met/Stab and pK) Counseling in the field of MedChem Synthesis platform (48 reactions) Liquid and solid phase reactions Reactions under inert gas Automated work-up (Filtration, Extraction, Chromatography, HPLC) Synthesis of single compounds, APIs and excipients Minimized scale Up to 10 kg batches Contact PharmBioTec GmbH Science Park 1 Campus Gebäude D 1.1 66123 Saarbrücken Tel.: +49 (681) 3096 325 Fax: +49 (681) 3096 330 [email protected] www.pharmbiotec.de PharmBioTec is a university owned CRO offering high quality services in pharmaceutical R&D during several stages of the drug discovery and development process. In 2010 three well-known professors of Saarland University (Prof. Hartmann, Prof. Lehr & Prof. Müller) have combined their extensive knowledge in different fields of pharmaceutical sciences to form a flexible company that facilitates free flowing innovation transfer between university, research institute and industry. It can revert to se- veral decades of experience in design, synthesis, biological evaluation, formulation and analysis of new drugs. PharmBioTec’s main objective is to establish and apply new techniques in the areas ANALYTICS/BIOTECHNOLOGY, DRUG DISCOVERY & SYNTHESIS and DRUG DELIVERY/BIOLOGICAL BARRIERS.
Transcript of in vitro models of Synthesis of API biological barriers ...€¦ · 7/11/2017 · veral decades of...
GMP
Pharmaceuticalformulations &
Nanoformulation
GMP-Analytics ofPeptides, Proteins,
small molecules& finished drugs
Generation of libraries
(CombiChem)MedChem
in vitro models of biological barriers
Synthesis of API and excipients
in small batches
Dru
g D
eliv
ery/
Biol
ogic
al B
arrie
rs
Biological Barriers
Lung Upper airways & deep lung Particle deposition devices
Skin
Human & porcine skin Permeation experiments Penetration experiments Intestine Healthy and in�amed state Combined dissolution
Drug Delivery
Development of pharmaceutical formulations Nanomedicine Drug Delivery systems Non invasive analytical techniques (Confocal Raman microscopy)
A
nal
ytic
s
GMP certi�ed according to §14 AMG Analytics of APIs and �nished drugs
Characterisation of biopharmaceuticals Development of methods Validation of methods (ICH, ECP)
Techniques
HP- liquid chromatography - hrMS HPLC - DAD / - UV Capillary electrophoresis (CE), CE - hr MS Calorimetry (DSC) Karl- Fischer water determination
Gel electrophoresis (CE-SDS, SDS-PAGE, IEF & native PAGE) Western Blotting and ELISA Protein identi�cation Particle characterization Stability test according to CPMP/ICH/2736/99 (Q1A) Photostability test according to CMPM/ICH/279/95 (Q1B)
Drug D
iscovery & Synthesis
Medicinal Chemistry Combinatorial Chemistry
Organic synthesis
Establishing of structure activity relationships Optimization of hits and leads Surface Plasmon Resonance (SPR) spectroscopy Detection and quanti�cation of Small Molecules in biological matrices (for Met/Stab and pK) Counseling in the �eld of MedChem
Synthesis platform (48 reactions) Liquid and solid phase reactions Reactions under inert gas Automated work-up (Filtration, Extraction, Chromatography, HPLC)
Synthesis of single compounds, APIs and excipients Minimized scale Up to 10 kg batches
ContactPharmBioTec GmbH
Science Park 1Campus Gebäude D 1.1
66123 Saarbrücken
Tel.: +49 (681) 3096 325 Fax: +49 (681) 3096 330
PharmBioTec is a university owned CRO offering high quality services in pharmaceutical R&D during several stages of the drug discovery and development process. In 2010 three well-known professors of Saarland University (Prof. Hartmann, Prof. Lehr & Prof. Müller) have combined their extensive knowledge in different fields of pharmaceutical sciences to form a flexible
company that facilitates free flowing innovation transfer between university, research institute and industry. It can revert to se-veral decades of experience in design, synthesis, biological evaluation, formulation and analysis of new drugs. PharmBioTec’s
main objective is to establish and apply new techniques in the areas ANALYTICS/BIOTECHNOLOGY, DRUG DISCOVERY & SYNTHESIS and DRUG DELIVERY/BIOLOGICAL BARRIERS.
