PharmaGrade™ products to be integrated into the Emprove® Program

Emprove

Our current PharmaGrade™ products – which include specialty chemicals, buffers, and amino acids – will be integrated into the Emprove® program.

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.

What is the Emprove® Program?

Emprove Program

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.

More information about Emprove® Expert and Emprove® Essential.

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

Material Qualification Dossier

In line with CTD chapter 3 quality (adapted for excipients)
  • General information
  • Manufacture
  • Characterization
  • Control of drug substance
  • Reference standard
  • Materials
  • Container closure system
  • Stability
  • Information to start a material qualification

Quality Management Dossier

  • Quality Self Assessment
  • Audit report summary
  • Supply chain Information
  • Stability data
  • Answers questions during risk assessment

Operational Excellence Dossier

  • Product quality report
  • Elemental impurity information
  • Analytical procedure
  • Supports process optimization

A glance at our Emprove® Program product categories:

Product Quality Attributes

Emprove® Evolve

Emprove® Essential & Emprove® Expert

Regulatory

  • Non-GMP but utilizing GMP concepts and elements
  • Evolving regulatory needs for transparency and control; no defined standards
  • Non-compendial, not for direct human use
  • GMP: IPEC plus elements of ICH
  • Defined regulations and GMP standards
  • Compendial compliance, suitable for human use

Examples of use/Application

(Examples only: customers’ responsibility to assess and decide on appropriate quality of raw materials for their use)
  • Process chemicals & cleaning in place (CIP)
  • Upstream, early downstream (biopharma)
  • Pre-registered stages (small molecule)
  • Close to final drug product & patient
  • Formulation, late downstream & purification

Assurance of product consistency

  • Manufacturing process verification
  • Analytical method proven suitability
  • Manufacturing process validation according to IPEC GMP
  • Analytical method validation according to ICH Q2

Product shelf-life/stability

  • Shelf-life based on analysis of 3 batches/historical data/ongoing retests
  • Stability studies according to ICH Q1
  • Detailed stability study data in dossier

Supplier qualification

  • High
  • Minimum paper audit, on-site audit optional
  • High
  • Minimum on-site audit

Change control

  • High
  • Target 3 months notification period
  • High
  • Target 6 months notification period
Learn more about our Emprove® Program