NEW! Emprove® Evolve for Raw Materials Used in Early Stages of (Bio-) pharmaceutical Manufacturing

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The new Emprove® Evolve product line provides fit-for-purpose high-quality raw materials addressing applications in early stages of pharmaceutical and biopharmaceutical manufacturing such as:

• upstream processing
• early downstream processing
• clean-in-place
• early synthetic steps in small molecule drug manufacture.

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Regulations for raw materials

These critical raw materials have no clearly defined regulatory standards or quality requirements but are coming more and more into regulatory focus. The Emprove® Evolve product line supports your quality risk assessment with detailed documentation and supply chain transparency and control also helping you to meet developing regulatory requirements for critical raw materials.

The perfect opportunity to be ahead of the regulatory challenges.

Why Emprove® Evolve?

The Emprove® Evolve product line takes the next step in advancing the Emprove® portfolio. This new range of products fills the gap between lab-grade and GMP-compliant raw and starting materials. This new category gives you easy access to Emprove® quality, matching the demands of the earliest stages of your manufacturing process by lending GMP elements to non-GMP material.

How does Emprove® Evolve fit into the existing categories?

The high level of characterization and documentation allows you to take more control of the inputs to your manufacturing process, by using high-quality raw materials which are a product of controlled manufacturing and release processes.

EMPROVE® EVOLVE product line provides detailed and transparent supply chain information and documentation to support risk assessments for critical raw materials used in manufacturing processes.	EMPROVE® ESSENTIAL product line is designed for moderate risk levels. Best-in-class regulatory support is combined with our high quality standards.
EMPROVE® API product line provides the right quality and regulatory documentation required for active pharmaceutical ingredients. All the products in this line are manufactured in Europe and comply with ICH Q7 requirements.	EMPROVE® EXPERT product line addresses higher risk applications, where the lowest microbiological and endotoxin levels are of utmost importance. These products are documented as being manufactured with low microbio logical and endotoxin levels.

Main Quality Attributes - Side by Side

Quality Categories
Emprove® Evolve	Emprove® Essential & Emprove® Expert
Regulatory Non-GMP: Manufactured utilizing GMP concepts and elements; ISO9001 or equivalent Supply chain transparency and control No defined industry standards or regulations Non-compendial, not for direct human use	Regulatory GMP: IPEC PQG GMP Guide and/or EXCiPACT™ Certification Standard plus elements of ICH Q7 Defined regulations and GMP standards Compendial compliance; intended as suitable for human use
Regulatory Example Uses/Applications Process chemicals & clean-in-place Upstream, early downstream, early synthetic steps	Regulatory Example Uses/Applications Higher risk applications Close to final drug product & patient Formulation, late downstream & purification
Product Shelf-life/Stability Shelf-life based on analysis of 3 batches/historical data/retest Summary statement in Emprove® dossier	Product Shelf-life/Stability Long-term stability studies according to ICH Q1A requirements Detailed stability study data in Emprove® dossier
Supplier Qualification High On-site audit preferred; exceptions possible under certain conditions Paper assessment mandatory Change agreement	Supplier Qualification High On-site audit mandatory Quality/change agreement
Change Control High	Change Control High