Drug Substance Batch definition

Drug Substance Batch means a specific quantity of the Drug Substance that is intended to be of uniform character and quality and is produced during the same Batch Run.

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Drug Substance Batch means Drug Substance derived from [***] fermentation runs of Intermediate at [***] working volume scale producing [***] Intermediate Batches resulting in [***] of purified Drug Substance.

Drug Substance Batch means a drug substance Batch of Product manufactured at the Facility.

Examples of Drug Substance Batch in a sentence

ImmunoGen shall complete in accordance with the requirements of cGMP a Manufacturing Documentation and a Certificate of Analysis for every Drug Substance Batch and Drug Product Batch.
In this case the value of the destroyed Drug Substance will be calculated by multiplying the Drug Substance Batch Fee times the grams of Drug Substance destroyed in the manufacture of the Non-Conforming Batch of Drug Product divided by the total grams of Drug Substance in the next Batch.
If Sponsor does not provide notice of non-conformity in the time frame set forth above, Sponsor shall be deemed to have accepted such Drug Substance Batch.
X Review and approve Raw Materials, Resins, Consumables, or Drug Substance Batch as an outcome of an approved investigation report.
HCC shall retain a sufficient quantity of each Drug Substance Batch to perform at least two (2) full sets of duplicate quality control tests as described in Section 9.9. Retained repository samples shall be maintained in a suitable storage facility (under conditions set forth in the applicable Drug Substance Appendix) for a period of not less than five (5) years from the date of expiration of each Drug Substance Batch.
Lonza shall not be responsible for the cost of Raw Materials, Customer Materials and/or starting materials consumed in any Failed Drug Substance Batch or Failed Drug Product Batch except to the extent set forth in Clause 7.5.3.
If the dispute remains unresolved, the Parties, acting through their appropriate scientific and technical personnel shall meet to work through the analysis of one or more mutually agreed sample(s) taken from the Drug Substance Batch that is the subject of the dispute.
If the Drug Substance Batch production yield is repeatedly above or below the agreed upon average yield described in Section 2.3, as such average yield may be adjusted during the Term pursuant to the Continuous Improvement Program, the Parties will evaluate such trends and agree to negotiate in good faith a fair and equitable adjustment to the pricing for the Drug Substance.
The Parties agree to negotiate in good faith a reasonable discount to the Drug Substance Batch Price for engineering/reference Batches of Drug Substance that are not intended to be or required to be cGMP compliant.
Pharmacyclics will notify HCC of the expiration date for each Drug Substance Batch.

More Definitions of Drug Substance Batch

Drug Substance Batch means a production batch of a given Drug Substance manufactured in bulk form hereunder. The applicable batch size(s), in kilograms, for each Drug Substance shall be agreed to by the Parties and set forth on the corresponding Drug Substance Appendix.

Drug Substance Batch means a Batch of Drug Substance in its final dosage form.