Legacy SAFC PharmaGrade ^™ Portfolio
to be integrated into the Emprove ^® Program.

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.

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. 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™ portfolio is being integrated into our industry-leading Emprove® Program. The Emprove® Program supports your risk assessment and offers assistance in developing more robust processes. It not only covers the latest regulatory requirements, but also anticipates industry expectations not yet covered by regulation. The PharmaGrade™ products will be integrated into our Emprove® Program either as Emprove® Essential, Emprove® Expert, or included in our NEW Emprove® Evolve product line.

Emprove® 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. 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.

Regulations of Raw Materials Used During Production Process

To support drug manufacturers’ risk assessments and decisions on raw materials, the different Emprove® categories are designed to provide manufacturers with the ability to select the appropriate quality raw materials for their specific application.

What will change as a result of this integration?

With this integration, PharmaGrade™ products will benefit from being part of the established industry-leading Emprove® Program for raw and starting materials. In order to meet our exacting Emprove® standards, each PharmaGrade™ product will be requalified according to harmonized definitions and robust processes.

More information on the Emprove® Program can be found here .

The Emprove® Program also provides comprehensive and thorough documentation, via our extensive dossier library and Emprove® Suite.

Within the Emprove® program there are 3 different supporting Emprove® dossiers which accompany each product:

Our PharmaGrade™ product documentation will be upgraded and expanded from the current single dossier to the three-dossier Emprove® format, increasing the quality and quantity of information available for each product.

In addition, some technical features of the products will also be upgraded to meet the higher standards of the Emprove® program.

First phase of PharmaGrade™ products to be addressed

The integration of the PharmaGrade™ portfolio is taking place in several phases. The table below shows those products which are prioritized for phase one, starting in 2018. Detailed planning for these products has started but this list should be considered for information purposes only at this time. Formal change notifications for each product will be issued in due course, according to our quality procedures. In the interim we encourage all customers to discuss with their sales representative their demand and qualification requirements for these products. In each case there will be a period of time where both the legacy PharmaGrade™ product and new Emprove® product will be available in parallel, to provide supply security and allow time for customers to perform their change management activities.

We are committed to supporting our customers through this process and to avoiding any supply disruption as a result of this integration.