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Home » Services » Manufacturing Services

Manufacturing Services

An industry leader in specialty contract lab space for cell banking

ALG provides the most comprehensive cell banking and FDA compliance expertise and testing solutions to life science companies.

  • Bioproduct safety testing
  • Cell culture services
  • Cytotoxicity / cell culture / cell line generation
  • Detection of viruses / residual DNA
  • Disinfectant efficacy studies
  • GLP and cGMP Cell Bank production and characterization
  • Manufacturing services
  • Molecular-based assays
  • Molecular cloning and expression sysstems
  • Mycoplasma detection

All of our test labs are GLP/cGMP compliant. Our Quality System complies with GLP/cGMP regulations, and is ISO/IEC 17025:2017 accredited. 

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

Manufacturing Services

  • Reagents
  • Media
  • Aseptic filling of injectables and IV bags for preclinical studies
  • Aseptic assembly
  • Steam sterilization
  • Custom projects

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
  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 xis weeks using conventional approaches such as broth/agar cultures and DNA staining of indicator cell cultures. 

Detection of Viruses or 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 cGMP requirements.

We continuously add to our portfolio of services, which includes:

  • 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 and virucidal surrogate efficacy tests
  • Adventitious agent screening and validation of viral decontamination
  • Bovine and porcine viral assays (according to 9 CFR 113)
  • Retrovirus assays and 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, cell cultures 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-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 cGMP assays can be validated based on client needs. Full custom assay development available based on a target of your choice. 

ALG Compliance Tests

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