Microbiology and Molecular Biology

Microbiology

New Services (cGMP)

• Performing Chromogenic Assays (e.g. Heparin according to Ph.Eur. 2.7.5 and USP <208>; ELISA for Penicillins)

• Endotoxin Testing according to Ph.Eur. 2.6.14 (Methods C, D) and USP <85> using Turbidimetric and Chromogenic Methods

• Microbiological examination of nonsterile products: Tests for Burholderia cepacia complex in accordance USP<60>

• TOC (total organic carbon) in accordance Ph. Eur. 2.2.44, USP <643>, JP und KP

Tests in accordance with Ph.Eur. (cGMP)

• Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests acc. to 2.6.12

• Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms acc. to 2.6.13

• Microbial Examination of Herbal Medicinal Products for Oral Use and Extracts Used in Their Preparations acc. to 2.6.31

• Bacterial Endotoxins acc. to 2.6.14 (Method A)

• Microbiological Assay of Antibiotics acc. to 2.7.2

• Efficacy of Antimicrobial Preservation acc. to 5.1.3

• Water, Purified (Aqua purificata; Monograph 0008)

• Water for Injection (Monograph 0169)

• Water for Preparation of Extracts (Monograph 2249)

Tests in accordance with USP (cGMP)

• Chapter <51> Antimicrobial Effectiveness Testing

• Chapter <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Test

• Chapter <62> Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms

• Chapter <81> Antibiotics-Microbial Assay

• Chapter <85> Bacterial Endotoxins Test

Additional Services

• Product-Specific Validations (acc. to Ph.Eur. and USP)

• Development and Validation of Rapid Test Methods (e.g. Simplate®)

• Microbial Assay of Vitamins

• Identification of Germs

Microbiological Tests - Hygiene Monitoring (cGMP)

• Sampling by Trained Stuff

• Investigation

• Germ Identification to Genus Level (Identification on a Species Level can be done via Subcontracting)

• On request we can supply the necessary additional information about detected bacteria and their possible sources of contamination
  
  Molecular Biology

  • Cell-based tests / biological activity tests

  • Cell migration assays

  • Cell proliferation/inhibition assays

  • Binding and/or competitive assays

  • Monocyte activation test (Ph. Eur. 2.6.30)

  • Enzyme-linked Immunosorbent Assay (ELISA)

  • Residual Host Cell Protein Assays (HCP) with ELISA (e.g. according to Ph. Eur. 2.6.34)

  • RNAse/DNAse through Gel electrophoresis