Layout and wording of certificates and statements as a result of harmonizationĭistribution / supply chain / ordering process elemental impurity information, bioburden, volatile impurity profiles)Īddition of improved stability and shelf-life data New tests added to product specification (in some cases)Įxtended impurity profiling (eg. Primary packaging volumes or material of construction Product name (to reflect the Emprove® category Expert, Essential or Evolve) In addition, some technical features of the products will also be upgraded to meet the higher standards of the Emprove® program. Some examples of such an evolving regulatory environment are upstream and early downstream bioprocessing, clean-in-place, and early synthetic steps in small molecule drug manufacture. The PharmaGrade™ products will be integrated into our Emprove® Program either as Emprove® Essential, Emprove® Expert, or included in ourĮmprove® Evolve products address applications with a need for supply chain transparency and control, as well as detailed documentation to support risk assessments, but where no specific regulatory standard exists. It not only covers the latest regulatory requirements, but also anticipates industry expectations not yet covered by regulation. The Emprove® Program supports your risk assessment and offers assistance in developing more robust processes. 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.įollowing a thorough review process, the PharmaGrade™ portfolio is being integrated into our industry-leading Emprove® Program. The PharmaGrade ™ portfolio of biopharma raw materials was developed to resolve a fundamental bioprocess challenge: sourcing specialized raw materials with transparent and consistent supply chains, without adding unnecessary cost or complexity. Please contact your sales representative to discuss your needs during the integration process Our PharmaGrade ™ product portfolio – which includes specialty chemicals, buffers, and amino acids – is being integrated into the Emprove® Program.
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