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Product Name

GMP contract Process Development and Manufacturing (Cells, MABs, Rec Proteins, DNA) offered by Areta

Organization name

Areta international

URL

http://www.aretaint.com

Profile

Areta develops new, rapid and reliable methods and technologies to produce molecules and cells for diagnosis as well as for therapy (monoclonal antibodies, recombinant proteins, cells, diagnostic kits).

Areta International was founded by Dr. Maria Luisa Nolli in autumn 1999 as a spin-off of cell biology Laboratories of Lepetit Research Center, a subsidiary of Dow Pharma, Merrell Dow, Marion Merrell Dow and then Hoechst Marion Roussel, where she had a twenty years experience as scientist and team leader.

Areta obtained in 2004 the GMP authorization to the manufacturing of monoclonal antibodies and recombinant proteins.

The company plays a role in the crucial phase of process development and batches manufacturing for pre-clinical and clinical studies, where the human safety and efficacy of a new drug have to be confirmed. Areta can tailor the production schedule to the real need of the customer avoiding massive production at the beginning of the project (that may result in huge losses of product and money) by the proper application of process development to built a robust process for the advanced phases in the long trail of a drug to become a product.

With this aim the company has been organized in two divisions:

ARETA GMP with a high containment plant for cell culture authorized by the Italian Ministry of Health to the GMP production of batches for Phase I and Phase II clinical studies

ARETA RESEARCH specialized in generation and production of monoclonal antibodies and set up of immunological and cell based tests needed for characterization and quality control of new biodrugs during their development.

Services offered include:

Filling and Media Fill

  • Filling in aseptical condition is validated by the filling of bacteria culture medium to demonstrate the capability of the system to provide sterile materials

Recombinant Protein Production

  • Production and purification of recombinant protein both in mammalian cells and E.coli
  • Cell line/strain production set up
  • Adaptation to serum free medium
  • Selection of appropriate bioreactor for the scale up production
  • Selection the most appropriate processing method
  • Set up of analytical methods to be used the production and purification process

ELISA ASSAY

  • Generation of Monoclonal Antibodies specific for any type of antigen
  • Test design (direct, indirect, sandwich, competitive)
  • Dose-response curve, linear range
  • Sensitivity determination
  • Detection limit
  • Precision
  • Accuracy 

Cell Based Test

  • Screening Tests for new drugs  
    • Evaluation of potential oral absorbability of drugs
    • Immunomodulation assays
  • Cytotoxicity tests

Additional information and contact data are available online.


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