BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION Welcome to the world of BioChem COMPANY PRESENTATION DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem analytical laboratory one of the leading German- ▪ based analytical laboratories more than 40 years of experience ▪ independent, family-owned ▪ located in Karlsruhe, south-west Germany ▪ expertise of more than 80 in-house specialists ▪ three core competencies: ▪ microbiology • analytics • molecular biology/bioanalytic • DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem quality assurance quality approved full service provider: GMP-certified (last inspection: April 2017) ▪ GLP-certified (last inspection: December 2017) ▪ FDA-registered and successfully inspected ▪ (last inspection November 2017) approx. 30 customer-based audits per year ▪ regular self-inspections ▪ DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem further authorisations authorisation for … ▪ handling of narcotics according to §3 BtmG ▪ handling of narcotic precursor according to GÜG and (EG) 273/2004 Art. 3 Abs. 2 of category 1 substances ▪ operation of genetic engineering facility according to GenTG and GenTAufzV as well as GenTSV of security level 1 and 2 according to GenTSV (biosafety level 2 GMOs on a project-by- project basis only) Furthermore BioChem has notified competent authorities about: handling of pathogenic organisms according to §§ 44 IfsG ▪ ▪ handling of epizootic disease germs according to TierSeuchErV DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem analytical laboratory internationally active: customers e.g. from Europe, ▪ Russia, China, Japan, Singapore, Jordan, Saudi-Arabia, Israel, USA, Mexico, Brazil Customers: life science industry ▪ pharmaceutical industry • chemical industry • medical device industry • cosmetics industry • diagnostics industry • DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem business activities quality control and development testing ▪ all dosage forms ▪ method development, transfer and validation ▪ identity, assay, purity and residue ▪ cleaning validation ▪ release and stability testing ▪ EU re-analysis ▪ storage according to ICH-guidelines ▪ GMP-/GLP-like documentation ▪ testing procedures, protocols and reports ▪ registration and submission support ▪ DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem CORE COMPETENCIES DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem MICROBIOLOGY excerpt from our microbiological portfolio: bacterial endotoxin testing ▪ assay of antibiotics ▪ sterility testing ▪ efficacy of preservation testing ▪ microbial contamination testing ▪ environmental monitoring ▪ non-routine testing and special testing for ▪ almost all microbiological questions For more details please contact our experts. DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem ANALYTICS excerpt from our analytical portfolio: chromatography ▪ spectroscopy ▪ elemental analysis ▪ physico-chemical testing ▪ dissolution testing ▪ ▪ stability testing For more details please contact our experts. DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem MOLECULAR BIOLOGY excerpt from our molecular biological/bioanalytical portfolio: DNA/RNA testing ▪ protein/antibody testing ▪ biotechnological product testing ▪ bioassay/enzymatic assay ▪ biological contamination testing ▪ For more details please contact our experts. DECEMBER 2017
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION For more details please contact us BioChem Labor für biologische und chemische Analytik GmbH Daimlerstraße 5b | 76185 Karlsruhe, Germany | Phone: +49 721 9737-0 E-Mail: biochem@biochem.de | www.biochem.de A member of the BioChem Group DECEMBER 2017
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