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:
early downstream processing
early synthetic steps in small molecule drug manufacture.
Learn more about our different Emprove® Categories
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 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.
PharmaGrade™ Product Number/New EMPROVE® Product Number
Target Emprove® Category
Tropolone Q1 Early Q2 2019
Oleic Acid Later 2019
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
Emprove® Essential & Emprove® Expert
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
GMP: IPEC/EXCiPACT™ plus elements of ICH
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
Higher risk applications
Close to final drug product & patient
Formulation, late downstream & purification
Shelf-life based on analysis of 3 batches/historical data/retest
Summary statement in Emprove® dossier
Long-term stability studies according to ICH Q1A requirements
Detailed stability study data in Emprove® dossier
On-site audit preferred; exceptions possible under certain conditions
Paper assessment mandatory
On-site audit mandatory
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