Our PharmaGrade™ biopharma raw materials were developed to resolve a fundamental bioprocess challenge: sourcing specialized raw materials with transparent and consistent supply chains, without adding unnecessary cost or complexity. With controlled manufacturing processes, optimized quality attributes and analytical specifications, and readily available quality documentation packages, PharmaGrade™ products provide efficiency and reliability for biopharma raw material qualification.
Following a thorough review process, the PharmaGrade™ products will be integrated into our Emprove® Program either as Emprove® Essential or Emprove® Expert products, or included in our new Emprove® Evolve product line. Emprove® Evolve products address areas with a need for supply chain transparency and control, as well as detailed supply chain information and documentation to support risk assessments, but where no specific regulatory standard exists. Some examples of such an evolving regulatory environment are upstream and early downstream bioprocessing, cleaning in place, and early synthetic steps in small molecule drug manufacture. Whilst it is the drug manufacturers’ responsibility to assess and decide on appropriate quality of raw materials for their specific needs, the different Emprove® categories are designed to support consistency and robustness in a variety of processing stages and uses.
The Emprove® Program supports your risk assessment and offers assistance in developing more robust processes. It also provides comprehensive and thorough documentation of our filters and single-use components as well as pharma raw and starting materials. It not only covers the latest regulatory requirements, but also anticipates industry expectations not yet covered by regulation.