PharmaGrade™ Product Portfolio

Our PharmaGrade™ product portfolio of 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.

Following a thorough review process, the PharmaGrade™ portfolio is being integrated into our Emprove® Program either as Emprove® Essential, Emprove® Expert, or included in our NEW Emprove® Evolve category.

What will change?

In order to meet our exacting Emprove® standards, each PharmaGrade™ product will be requalified according to harmonized definitions and robust processes.

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.

 

 
Will Change
Won’t Change

Product/Article number

X  
Product name (to reflect the Emprove® category Expert, Essential or Evolve) X  
Manufacturing site   X
Manufacturing process   X
Raw materials / sources   X*
Increased product dossier content X  
Primary packaging volumes or material of construction   X*
Existing specification parameters   X*
New tests added to product specification (in some cases) X  
Extended impurity profiling (eg. elemental impurity information, bioburden, volatile impurity profiles) X  
Addition of improved stability and shelf-life data X  
Layout and wording of certificates and statements as a result of harmonization X  
Label format and branding X  
Distribution / supply chain / ordering process   X
*No intended change: Change only to be made when necessary to meet higher Emprove® standards

Phases of integration

The integration of the PharmaGrade™ portfolio is taking place in several phases. The table below shows those products which are prioritized for phase one, started in 2018. Formal change notifications for each product will be issued in due course, according to our quality procedures.

 

PharmaGrade™
Product Number
New Emprove®
Product Number
Product Name Manufacturing Site Target
Emprove®
Category
12063 137123 Benzalkonium Chloride Buchs, Switzerland Expert
76857 137124 aq. Benzalkonium Chloride Solution Buchs, Switzerland Expert
15702 108637 Tropolone Buchs, Switzerland Evolve
76078 104309 L-Methionine Sulfoximine Buchs, Switzerland Essential
80443 105477 Sodium Pyruvate Buchs, Switzerland Essential
02712 108318 Cystamine Dihydrochloride Buchs, Switzerland Essential
ARK2163 137120 Benzyl Alcohol, USP/NF, EP Arklow, Ireland Expert
ARK2176 137129 Galactose Arklow, Ireland Expert
ARK2183 137130 Acetic acid, Glacial, USP, JP, Ph Eur Arklow, Ireland Expert
ARK2161 137127 Sodium Butyrate Arklow, Ireland Expert
ARK2174 137148 Triethanolamine, USP Arklow, Ireland Expert
ARK2169 137133 Ethanolamine Arklow, Ireland Expert
53729 137139 Cysteamine Hydrochloride Buchs, Switzerland Essential
07604 137151 2-Mercaptoethanol Buchs, Switzerland Evolve
11317 137152 Methanesulfonic Acid Buchs, Switzerland Essential
56454 108704 1-Thioglycerol, USP Buchs, Switzerland Essential
ARK2151 137126 Hexylene Glycol Arklow, Ireland Expert
C1231 137132 SyntheChol™ Synthetic Cholesterol Arklow, Ireland Expert

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