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

  • Authorities 23 CFR 230.409 FHWA Form-1273 Types of Comprehensive Compliance Reviews NDOT performs two types of Comprehensive Compliance Reviews: project-based and contractor-based.

  • 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.

  • Customer acknowledges and agrees that its sole remedy with respect to a Failed Drug Substance Batch and/or Failed Drug Product Batch that is a Lonza Responsibility is as set forth in Clauses 7.4 and 7.5. Accordingly, other than if due to Lonza’s gross negligence or intentional breach, Customer hereby waives all other remedies at law or in equity regarding the foregoing claims.

  • If there is a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within the relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall appoint an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the cGMP Drug Substance Batch that allegedly fails to conform to Specifications.

  • If Lonza believes that a cGMP Drug Substance Batch, which was required by the terms of this Agreement to meet Specifications, has been incorrectly rejected, Lonza may require that Customer provides samples to Lonza for testing.

  • Notwithstanding the foregoing should any cGMP Drug Substance Batch Released hereunder have a Latent Defect, Customer shall notify Lonza of such Latent Defect within [***] days after Customer becomes aware of such Latent Defect and in any event no later than [***] months after delivery of the applicable Batch; provided that such Latent Defect was not reasonably detectable by inspection within [***] days of Release.

  • The Parties further agree that in the event that any Batch is a Failed Drug Substance Batch or a Failed Drug Product Batch and such failure is caused by any defect in any Customer Information, Customer Material, Cell Line, Customer Background Intellectual Property, and/or any other information, material or Intellectual Property supplied by or on behalf of the Customer, then Lonza shall not have any liability with regard to such Failed Drug Substance Batch or Failed Drug Product Batch.

  • Except if due to Lonza’s gross negligence Lonza shall not be responsible for (i) the cost of Raw Materials (except to the extent set forth in Clauses 7.4.3 and 7.5.3), Customer Materials, Drug Substance required for the manufacture of a cGMP Drug Product Batch, and/or (ii) starting materials consumed in any Failed Drug Substance Batch or Failed Drug Product Batch.

  • Each day I would take them one by one and hypnotise them in the car.

  • Except if due to Lonza’s gross negligence, nothing in Clause 7.4 or 7.5 shall oblige Lonza to replace or refund any Drug Substance material produced by a cGMP Drug Substance Batch (or manufacture an additional cGMP Drug Substance Batch) or any other drug substance that may be required to produce any replacement cGMP Drug Product 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.
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Related to Drug Substance Batch

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Manufacturing Process means any process for—

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • API means American Petroleum Institute.

  • Active Ingredient means any com- ponent that is intended to furnish pharmacological activity or other di- rect effect in the diagnosis, cure, miti- gation, treatment, or prevention of dis- ease, or to affect the structure or any function of the body of humans. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

  • Harvest batch means a specifically identified quantity of dried flower or trim, leaves, and other cannabis plant matter that is uniform in strain, harvested at the same time, and, if applicable, cultivated using the same pesticides and other agricultural chemicals, and harvested at the same time.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.