BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION Welcome to the world of BioChem COMPANY PRESENTATION JUNE 2019
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem analytical laboratory one of the leading German- ▪ based analytical laboratories more than 45 years of experience ▪ independent, family-owned ▪ located in Karlsruhe, south-west Germany ▪ expertise of about 100 in-house specialists ▪ our three core competencies: ▪ microbiology • analytics • molecular biology/bioanalytics • JUNE 2019
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem quality assurance quality approved full service provider: GMP-certified (last inspection: April 2017 ▪ next inspection planned in July 2019) GLP-certified (last inspection: December 2017) ▪ FDA-registered and successfully inspected ▪ (last inspection: November 2017) approx. 30-40 customer-based audits per year ▪ regular self-inspections ▪ JUNE 2019
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 JUNE 2019
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 • JUNE 2019
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 ▪ JUNE 2019
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem CORE COMPETENCIES JUNE 2019
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. JUNE 2019
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. JUNE 2019
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 ▪ ▪ amino acid analysis For more details please contact our experts. JUNE 2019
BIOCHEM KARLSRUHE GERMANY COMPANY PRESENTATION BioChem Centre of excellence for the IDENTIFICATION OF MICROORGANISMS All methods for identification of bacteria, yeasts and moulds from one hand: microscopic/morphological analysis ▪ mass spectrometry analysis by MALDI TOF ▪ molecular biological testing by : ▪ largest available GMP-compliant database with 16S-/18S-/ITS-rDNA-sequences of more than 50,000 species JUNE 2019
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 JUNE 2019
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