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. 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™ portfolio is being integrated into our industry-leading Emprove® Program. The Emprove® Program supports your risk assessment and offers assistance in developing more robust processes. It not only covers the latest regulatory requirements, but also anticipates industry expectations not yet covered by regulation. The PharmaGrade™ products will be integrated into our Emprove® Program either as Emprove® Essential, Emprove® Expert, or included in our NEW Emprove® Evolve product line.
Emprove® Evolve products address applications with a need for supply chain transparency and control, as well as detailed 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, clean-in-place, and early synthetic steps in small molecule drug manufacture.
To support drug manufacturers’ risk assessments and decisions on raw materials, the different Emprove® categories are designed to provide manufacturers with the ability to select the appropriate quality raw materials for their specific application.
With this integration, PharmaGrade™ products will benefit from being part of the established industry-leading Emprove® Program for raw and starting materials. In order to meet our exacting Emprove® standards, each PharmaGrade™ product will be requalified according to harmonized definitions and robust processes.
More information on the Emprove® Program can be found here.
The Emprove® Program also provides comprehensive and thorough documentation, via our extensive dossier library and Emprove® Suite.
Within the Emprove® program there are 3 different supporting Emprove® dossiers which accompany each product:
|Will Change||Won't Change|
|Product name (to reflect the Emprove® category Expert, Essential or Evolve)||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|
The integration of the PharmaGrade™ portfolio is taking place in several phases. The table below shows those products which are prioritized for phase one, starting in 2018. Detailed planning for these products has started but this list should be considered for information purposes only at this time. Formal change notifications for each product will be issued in due course, according to our quality procedures. In the interim we encourage all customers to discuss with their sales representative their demand and qualification requirements for these products. In each case there will be a period of time where both the legacy PharmaGrade™ product and new Emprove® product will be available in parallel, to provide supply security and allow time for customers to perform their change management activities.
|Product Name||Manufacturing Site||PharmaGrade™ Quality Level||Target Emprove® Category|
|ARK2163||Benzyl Alcohol, USP/NF, Ph.Eur||Arklow, Ireland||GMP PharmaGrade™||Expert|
|ARK2161||Sodium Butyrate, USP/NF||Arklow, Ireland||GMP PharmaGrade™||Expert|
|ARK2176||Galactose, USP/NF, Ph.Eur||Arklow, Ireland||GMP PharmaGrade™||Expert|
|C1231||SyntheChol™ Synthetic Cholesterol, USP/NF, Ph.Eur||Arklow, Ireland||GMP PharmaGrade™||Expert|
|ARK2183||Acetic acid, Glacial, USP, JP, Ph.Eur||Arklow, Ireland||GMP PharmaGrade™||Expert|
|12063||Benzalkonium Chloride, Ph.Eur, USP, JP||Buchs, Switz.||GMP PharmaGrade™||Expert|
|76857||aq. Benzalkonium Chloride Solution, Ph.Eur, USP||Buchs, Switz.||GMP PharmaGrade™||Expert|
|15702||Tropolone||Buchs, Switz.||Elite PharmaGrade™||Evolve|
|76078||L-Methionine Sulfoximine||Buchs, Switz.||GMP PharmaGrade™||Essential|
|80443||Sodium Pyruvate||Buchs, Switz.||GMP PharmaGrade™||Essential|
|ARK2151||Hexylene Glycol, USP/NF||Arklow, Ireland||GMP PharmaGrade™||Expert|
|ARK2169||Ethanolamine, USP/NF||Arklow, Ireland||GMP PharmaGrade™||Expert|
|02712||Cystamine Dihydrochloride||Buchs, Switz.||GMP PharmaGrade™||Essential|
|56454||1-Thioglycerol, USP||Buchs, Switz.||GMP PharmaGrade™||Essential|
|91541||Oleic Acid||Buchs, Switz.||Elite PharmaGrade™||Evolve|
|93792||Benzenesulfonic Acid||Buchs, Switz.||GMP PharmaGrade™||Essential|