Thursday, January 24, 2013

The safety of raw materials

Raw materials are the heart and soul of any product produced from biopharmacetucials. It's critical to be aware of where the raw materials are coming from and the manufacturing process that was behind them, as this can lead to major, unintended outbreaks through the populations of patients using the end product.  At the Cell Culture Dish, they recently looked at a few ways to improve and maintain the quality of raw materials used in biopharmaceuticals throughout the world.

So what steps can countries and Pharma companies take to ensure the quality of raw materials?
  • -Leave animal products out of the manufacturing equation.  These lead to the highest risk of possible contamination
  • -There is a lot of pressure to cut corners to bring down the cost of healthcare.  However, there are safe ways to do this during the manufacturing process including improved filtration systems and single use systems.
  • -The source of the raw materials needs to be known.  Pharmaceuticals companies should obtain their raw materials from factories and plants that that are regulated by the FEA or EMA
Next month at the Biopharmaceutical Development and Production Event, Kate Bishop Winchester, Manager, Global Biologics MSAT, Cell Culture at Genentech will be on hand to discuss The Impact of Raw Material Variability, Foreign Material and Second Sourcing, covering many of the items discussed in this article.  For more information on this session and the rest of the program, download the agenda.  If you'd like to join us, register to join us toady and mention code BDPJP13 and save 20% off the standard rate.*

*This rate does not apply if you've already registered to join us.

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