mastpharma® development & stability

mastpharma® development & stability

Mast Group offers a range of services including mastpharma® development and stability for the evaluation of novel antimicrobial compounds for the pharmaceutical industry.

Utilising over 65 years of experience of development and manufacture of antimicrobial test products mastpharma® offers extra confidence in the success of the antimicrobial on final commercialisation.

We offer flexible and convenient services to provide pharmaceutical companies with confidence in quality and assist with easy distribution and integration for market evaluations.

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mastpharma® development

In the disc development phase an antimicrobial susceptibility test (AST) disc containing a novel compound is formulated. Additionally, methods for the assay of its contents are verified. Initial stress studies identify the most suitable candidate formulation for the production of stable investigational use only (IUO) AST discs, preliminary QC criteria are generated during this process.

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mastpharma® stability

For this service we offer a minimum of three replicate batches of product are manufactured and entered into real-time stability studies. Studies carried out over an 18 month period under both normal storage and additional stress conditions allow trending to be monitored and ensure final product retains effective performance for the duration of its allocated shelf life.

Mast Group offers the following flexible and convenient services to provide pharmaceutical companies with confidence in quality, and assist with easy distribution and integration for market evaluations:

  • Continuation of performance studies are available at 3, 6, 9 and 12 months on first batch manufacture.

  • On compound approval by the FDA and EMA,CLSI and EUCAST disc versions are made available. Antibiotic discs are then launched and supplied as part of the MASTDISCS® stock range.

  • Bespoke labelling available to customer’s specification fulfilment programmes.

  • Distribution to end users on behalf of pharmaceutical company.

  • Multiple disc cartridge formats meet international requirements.

Want to find out more about mastpharma®

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