Bulk drug substance definition

Bulk drug substance means any substance that is represented for use, and that, when used in the compounding, manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug; however, "bulk drug substance" shall not include intermediates that are used in the synthesis of such substances.
Bulk drug substance means any substance that is represented for use, and that, when used in the
Bulk drug substance means a Drug Product Candidate in bulk crystal, powder or other form suitable for incorporation in a Drug Product.

Examples of Bulk drug substance in a sentence

  • Bulk drug substance (BDS) batches of both Stable and Transient CH505TF gp120 proteins produced from CHO cells were purified by KBI Biopharma using multimodal and ion-exchange chromatography.


More Definitions of Bulk drug substance

Bulk drug substance means the Compounds in bulk form which, if appropriately formulated and finished, would be suitable for preclinical or clinical use or commercial use.
Bulk drug substance means a Compound in bulk crystal, powder, solution or other form suitable for incorporation in a Drug Product, which if required in order to stabilize the Compound shall be formulated with stabilizing excipients.
Bulk drug substance means an siRNA (including chemical modifications and covalent conjugates) or other active ingredient in bulk form manufactured for use as an active pharmaceutical ingredient in a Licensed Product.
Bulk drug substance means COMPOUND in bulk form which, if appropriately formulated and finished, would constitute PRODUCT, and which shall be supplied by TANABE pursuant to Section 7.1.
Bulk drug substance means the Compound in bulk form, which if appropriately formulated and finished, would constitute the Product.
Bulk drug substance means the active compound, as set forth in the Project Plan, to be supplied by CLIENT for use in Production of Drug Product.