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COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
COMPANY PRESENTATION
Welcome
to the world of BioChem
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
BioChem analytical laboratory
▪ one of the leading German-based GMP-certified
analytical contract laboratories
▪ more than 45 years of experience
▪ independent, family-owned
▪ located in Karlsruhe, Germany
▪ expertise of about 100 in-house specialists
▪ interdisciplinary competence, all from a single source:
• microbiology
• analytics
• molecular biology/bioanalytics
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
BioChem quality management
quality approved full-service provider:
▪ GMP-certified (last inspection: 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
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
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
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
BioChem analytical laboratory
▪ internationally active: customers e.g. from Europe,
Russia, China, Japan, Singapore, Jordan, Saudi-Arabia,
Israel, USA, Mexico, Brazil, Canada
▪ focus on customers from life science industry:
• pharmaceutical industry
• chemical industry
• medical device industry
• cosmetics industry
• diagnostics industry
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
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
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
BioChem CORE COMPETENCIES
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
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.
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
BioChem ANALYTICS
For more details please contact our experts.
excerpt from our analytical portfolio:
▪ determination of TOC/TN (water analysis/cleaning validation)
▪ particle measurement
▪ chromatography
▪ spectroscopy
▪ elemental analysis
▪ physico-chemical testing
▪ dissolution testing
▪ stability testing
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
BioChem MOLECULAR BIOLOGY
excerpt from our molecular biological/bioanalytical portfolio:
▪ determination of amino acids
▪ DNA/RNA testing
▪ protein/antibody testing
▪ biotechnological product testing
▪ bioassay/enzymatic assay
▪ biological contamination testing
For more details please contact our experts.
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
BioChem Centre of excellence for the
IDENTIFICATION OF MICROORGANISMS
All methods for the identification of
bacteria, yeasts and fungi from a single source:
▪ 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
▪ DNA fingerprinting: molecular biological
typing of bacterial and fungal isolates
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
BioChem NEW in 2019:
▪ additional 400 m² at our microbiological department
▪ additional 400 m² at our bioanalytical department
▪ BioChem:
GMP/GLP laboratory
services at 4,000 m²
at our site in Karlsruhe,
Germany
now even bigger
more powerful
more modern
COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
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: [email protected] | www.biochem.de
A member of the BioChem Group
