Know what’s inside:

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

More
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

Bioassay

Bioassay

GMP Testing

Contact us!

To learn more about us and what we can do for you please contact us.

Contact form
Contact form

Contact

Do you have any questions about our service?

Contact form
© 2024 GBA Group

Volg ons

  • linkedIn GBA Group
  • xing
  • gba youtube
  • gba Instagram
ContactPrivacy Juridische informatie Algemene voorwaardenColofon
Telefoon Telefoon
Jobs
Jobs