Agency
DAB
Quality Level
product line
EMPROVE® EXPERT
form
solid
application(s)
liquid formulation
pharmaceutical
SMILES string
[Cl-].[N+H3]CCCC(N)C(=O)O
InChI
1S/C5H12N2O2.ClH/c6-3-1-2-4(7)5(8)9;/h4H,1-3,6-7H2,(H,8,9);1H
InChI key
GGTYBZJRPHEQDG-UHFFFAOYSA-N
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General description
For protein-based therapeutics, such as monoclonal antibodies (mAbs) or plasma derived proteins, often highly concentrated protein formulations are required to meet intended dosing regimens. However, this usually comes with elevated viscosities and presents a challenge in the manufacturing process and final formulation. Our Viscosity Reduction Excipient Platform reduces the viscosity and helps overcome challenges associated with highly concentrated protein solutions.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.
Application
The Viscosity Reduction Platform is based on the combination of two new excipients, one amino acid component with one anionic component, that together can better reduce protein viscosity beyond levels achieved with single excipients. Also, combining the two components enables a balance of viscosity reduction and protein stabilization. L-Ornithine monohydrochloride Emprove® Expert DAB is part of this new proprietary technology platform.
Packaging
1371180100 // 100 G Plastic bottle
1371181000 // 1 KG Plastic bottle
1371189010 // 10 KG PE sac, plastic bucket
1371181000 // 1 KG Plastic bottle
1371189010 // 10 KG PE sac, plastic bucket
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany
Storage Class Code
11 - Combustible Solids
WGK
WGK 1
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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