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Home » Services » Manufacturing Services

Manufacturing Services

ALG provides manufacturing and FDA compliance expertise and testing solutions to life science companies. ALG’s Quality System complies with GxP regulations and is ISO/IEC 17025:2017 accredited. We provide safety testing and cell bank production services for biotech manufacturing services, testing laboratories and compounding pharmacies.

All test labs GMP compliant.

cGMP Cell Bank Production and Characterization

Mammalian Cell Bank

  • Manufacturing of cGMP Master and Working Cell Bank
  • Full Cell Bank Characterization Testing
  • Identity
  • Viability
  • Microbiological contaminants
  • Retroviruses
  • Adventitious viruses
  • Antibody production
  • Genetic stability

Microbial Cell Bank

  • Manufacturing of cGMP Master and Working Cell Bank
  • Full Cell Bank Characterization Testing
  • Identity
  • Viability
  • Purity
  • Bacteriophage
  • Genetic stability

Safety Testing

Microbiological Contaminants

  • Mycoplasma
  • Sterility

Retroviruses

  • Infectivity assays
  • PCR-based assays

Adventitious Viruses

  • In vitro assays for viral contaminants

Endotoxin: LAL

Biological Reactivity and Cytotoxicity

Residual DNase, RNase and Protease Activities

Cells at the limit of in vitro cell age or end of production cells

Unprocessed Bulk

Final Filled Product

ALG Compliance Tests

Listings by Qualifying Agency: