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Home » Services » Cell Banking Services

Cell Banking Services

ALG provides cell banking 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 cell banking services for biotech manufacturing services, testing laboratories and compounding pharmacies.

All test labs GLP/GMP compliant

Services

Mycoplasma detection

Mycoplasmas, the smallest and simplest prokaryotes, can contaminate cell cultures and cost biotechnology companies lost time and reduced profit. They are a unique group of microorganisms that fall within the category between the bacteria and viruses, and are causal agents of numerous diseases of animals and humans causing contamination in eukaryotic cell cultures. The presence of mycoplasmas in cellular lines may significantly influence the results of experiments because they may affect: 1) the cell growth rate which induces morphological changes which induces chromosomal aberrations, 2) the amino and nucleic acids’ metabolism inducing cell transformation, and 3) molecular transport through the cell membrane.

Currently, European and U.S. regulations demand that all cell lines used to make recombinant therapeutic proteins are routinely tested for mycoplasma, a process that can take four to six weeks using conventional approaches such as broth/agar cultures and DNA staining of indicator cell cultures.

Detection of viruses / residual DNA

ALG provides a variety of virology and cell-based assays for detection of viruses, residual DNA, and custom studies. We provide a broad range of Q-PCR and ELISA assays based on client needs and can develop and validate the assay to meet GLP or GMP requirements.

We continuously add to our portfolio of services and library of organisms, which include:

  • Growth and Tittering of viral stocks
  • Virucidal efficacy studies
  • Growth of Pseudotyped viruses (Retroviral, Adeno-viral AAV or Custom made to order)
  • Virucidal Activity Studies
  • Disinfectant Virucidal Efficacy Tests
  • Virucidal Surrogate Efficacy Tests
  • Adventitious agent screening and validation of viral decontamination.
  • Specific Viruses
  • Bovine Viral Assay (according to 9 CFR 113)
  • Porcine Viral Assay (according to 9 CFR 113)
  • Retrovirus Assays
  • XC Assay for Ecotropic Retroviruses
  • S+ L- Assay for Xenotropic Retroviruses

Cytotoxicity / cell culture / cell line generation

Cell cultures represent a standard in vitro model in biomedical research. Without the need of using laboratory animals, they allow for the complex study of cellular mechanisms, both under physiological, and experimental conditions. Their application ranges from the study of metabolic routes in basic research, to production of recombinant proteins in the biotech or pharmaceutical industries.

The techniques of working with cell cultures have been well established, and ALG has succeeded in establishing and standardizing a number of in vitro methodologies.

Molecular cloning and expression systems

Molecular cloning is not always straightforward to perform and can be very time consuming. Save time and effort by outsourcing your molecular biology project to ALG. Together, we will help to define a customized strategy to meet your requirements.

Bioproduct safety testing

ALG offers safety testing for biotechnology products derived from cell lines derived from human or animal origin.

Cell culture services

Disinfectant efficacy studies

Molecular-based assays

ALG offers a wide range of assay design and development services. Functional assays are designed, validated and customized to meet the needs of our pharmaceutical and biotechnology industry clients. These assays are aimed at assessing and monitoring the efficacy, tolerability and safety parameters of candidate therapeutics and prophylactics in cancer, infectious disease, autoimmunity and transplantation. Assays are derived from pertinent scientific literature or are directly implemented from our previously validated procedures. GLP and GMP assays can be validated based on client needs. Full custom assay development available based on a target of your choice.

Manufacturing Services

  • Reagents
  • Media
  • Aseptic filling of injectables and IV bags for preclinical studies
  • GLP & GMP cell bank preparation
  • Aseptic assembly
  • Steam sterilization
  • Custom projects

GLP & GMP Cell Bank Production and Characterization

ALG provides comprehensive mammalian and microbial cell banking services for the biopharmaceutical industry.

  • Master and working cell banks
  • Banks of 20 to 1,200 vials per lot
  • Complete GMP batch documentation including Certificate of Analysis
  • Cell Bank Characterization
  • Long-term storage of vials in liquid nitrogen under GMP conditions

ALG Compliance Tests

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