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QC - Quality Control

Biologics cGMP Manufacturing

Quality Control


Analytical methods design and analytical controls are critical aspects of the biopharmaceuticals development and cGMP manufacturing processes.

Our quality control laboratories provide full biochemical and microbiological controls of raw materials, environment, manufacturing processes, Drug Substances and Drug Products.
  • Raw materials: sampling and analysis according to specifications in compliance with pharmacopoeia monographies
  • Environmental monitoring: air, water and surface sampling and analysis according to pharmacopoeia monographies
  • Cells bank analysis: Batch release testing including safety testing, identity and microbiological strains characterization
  • Protein and plasmid analysis: Batch release testing including identity, purity, integrity, activity, safety (endotoxins, bioburden/ sterility), residual impurities (e.g. DNA, RNA, host cell proteins and media components)
  • DNA / protein characterization
  • Stability testing: in compliance with ICH guidelines
  • Analytical assays validation: in compliance with pharmacopoeia, ICH and cGMP guidelines

We provide a complete range of analysis such as:

Physical Chemistry

Safety

  • Physicochemical determinations (pH, conductivity, moisture, appearance, colour, etc.)
  • Limit tests (heavy metals, chlorides, phosphates, ignition residues, etc.)
  • Chemical tests (identity, TOC, dosage, etc.)
  • Sterility and pyrogenicity
  • Bacterial Endotoxins tests (Kinetic LAL method, Gel clot)
  • Abnormal toxicity

Biochemistry

Microbiology

  • Protein content (UV, Lowry, BCA,…..)
  • Immunological test for identity and impurity assays ( Western blot, ELISA)
  • Electrophoresis analyses (SDS-PAGE, IEF, agarose gel,…. )
  • HPLC analyses (gel permeation, DNA topology, ion exchange, RNA content, LC-MS,….)
  • Real time PCR assays (quantification of residual genomic DNA)
  • Restriction mapping- PCR for DNA identity test
  • Viable cell count (CFU)
  • Plasmid retention
  • Identification (API strips , microscopic examination, gram stain, …..)
  • Phenotype and/or genotype
  • Microbial limit tests
  • Microbial contaminant identification
  • Bioburden

Office

Kaneka Eurogentec S.A. Biologics Division
LIEGE Science Park
Rue du Bois Saint Jean, 14
4102 Seraing
BELGIUM

Tel.: +32 4 372 74 00
Fax: +32 4 365 16 04

info.biologics@eurogentec.com

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Download our Eurogentec Biologics profile

Technical inquiries

Pascal Bolon, Ph.D.
Biologics Sales & Marketing Manager

GMP Biologics Information Request

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