biochem karlsruhe germany company presentation
TRANSCRIPT
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COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
COMPANY PRESENTATION
Welcome
to the world of BioChem
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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
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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
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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
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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
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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
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COMPANY PRESENTATION
JULY 2020
BIOCHEM KARLSRUHE GERMANY
BioChem CORE COMPETENCIES
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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.
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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
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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.
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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
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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
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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