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Microbiology and Molecular Biology

GBA Pharma Labs - Microbiologie cGMP

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

The experienced and highly committed GBA Group team offers a variety of different services in the following Areas.

GBA Pharma Labs - GMP Testing

GMP Testing

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GBA Pharma Labs - GMP Quality Control

GMP Quality Control

GBA Pharma Labs - Method Development & Validation

Method Development & Validation

GBA Pharma Labs - Stability Studies

Stability Studies

GBA Pharma Labs - Dissolution

Dissolution

GBA Pharma Labs - Extractables & Leachables

Extractables & Leachables

GBA Pharma Labs - Packaging Material Testing

Packaging Material Testing

GBA Pharma Labs - Particle Determination

Particle Determination

GBA Pharma Labs - Elemental Impurities Testing

Elemental Impurities Testing

GBA Pharma Labs - Microbiology

Microbiology

GBA Pharma Labs - Regulatory Services

Regulatory Services

GBA Pharma Labs - Amino Acid Analysis

Amino Acid Analysis

GBA Pharma Labs - Instrumentation

Instrumentation

GBA Pharma Labs - N-nitrosamines

N-nitrosamines

GBA Pharma Labs - qPCR

qPCR

GBA Pharma Labs - iCEF

cIEF

GBA Pharma Labs - Protein characterization

Protein Characterization

GBA Pharma Labs - Limit test for DEG and EG by GC

Limit test for DEG and EG by GC

GMP Testing

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