DS Batch definition

DS Batch means the quantity of Drug Substance from a single formulation operation produced under cGMP and in accordance with a defined set of release criteria, using 1,000 liter, 2,000 liter, 15,000 liter or 18,000 liter working volume bioreactor, and as a result of a series of sequential inoculation cell culture, harvest and purification steps for manufacture of Drug Substance for inclusion in (i) products intended for commercial sale and (ii) products intended for use in clinical development.
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Examples of DS Batch in a sentence

  • In the event that Biogen fails to deliver a DS Batch under a Binding Purchase Order, Biogen shall remedy such shortfall as soon as commercially reasonable, but in no event later than six (6) months after the delivery date under such Binding Purchase Order.

  • The contractor shall produce approximately *** of cGMP BCX4430 drug product using drug substance from the *** cGMP BCX4430 (DS Batch ***, WBS 1.7.1).

  • One “Other Client Sample” and associated lab replicate and matrix spike/matrix spike replicate from a different batch (K1500147) were used by the lab for QA purposes, and were included in the review (records were flagged with the qualifier of DS (Batch Quality Assurance data from another project)).

  • The contractor shall produce approximately * * * , assuming * * * of BCX4430 is delivered from the DS Batch * * * of BCX4430, per GMP for use in clinical trials which will include active drug batches to support future clinical studies.

  • Metro Kids employees and preschool child care workers are required to undergo a physical that includes testing for tuberculosis every two years.

  • Duration: * * *Go/No Go Criteria to Initiate: WBS 1.4.1 Completion of Manufacture cGMP BCX4430 ( * * * campaign DS Batch * * * )Through completion of manufacturing of this Drug substance Batch * * * , then there will be material to conduct further regulatory activities such as the IM non-clinical NDA-enabling toxicology studies in this option.

  • The contractor shall produce approximately * * * , assuming * * * of BCX4430 is delivered from the DS Batch * * * of BCX4430, per GMP for use in clinical trials which will include active drug and placebo batches to support the future clinical safety study.

Related to DS Batch

  • 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.

  • Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.

  • 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.

  • Batch Record means the production record pertaining to a Batch.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Plasma arc incinerator means any enclosed device using a high intensity electrical discharge or arc as a source of heat followed by an afterburner using controlled flame combustion and which is not listed as an industrial furnace.

  • Lot or batch number means an identifying number assigned by the enterprise to a designated group of items, usually referred to as either a lot or a batch, all of which were manufactured under identical conditions.

  • Type A quantity means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A1 for special form radioactive material or A2 for normal form radio- active material, where A1 and A2 are given in Appendix O or may be determined by procedures described in Appendix O.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Definite quantity contract means a fixed price contract that provides for a

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Contract Quantity means the quantity of Delivered Energy expected to be delivered by Seller during each Contract Year as set forth in Section 3.1(e).

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Direction-indicator lamp means the lamp used to indicate to other road-users that the driver intends to change direction to the right or to the left;

  • Grab sample means an individual sample collected in less than 15 minutes in conjunction with an instantaneous flow measurement.

  • Small quantity generator means a generator who generates less than 1000 kg of hazardous waste in a calendar month.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Service Specification means and include detailed description, statements to technical data, performance characteristics, and standards (Indian as well as) as applicable and as specified in the Contract as well as those specifications relating to Industry standards and codes applicable to the performance of the work, work performance quality and the specifications affecting the works or any additional specification required to be produced by the DCO to meet the design criteria.

  • 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.

  • Swap Specification means, with respect to any Swap, the Rules or other trading protocols containing specifications for such Swap, as adopted, amended, supplemented or otherwise modified from time to time by BSEF.

  • 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.

  • 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.”

  • Certificate of Analysis means a document, signed by an authorized representative of Manufacturer, describing Specifications for, and testing methods applied to, Product, and the results thereof.

  • API means the American Petroleum Institute.

  • Type B quantity means a quantity of radioactive material greater than a Type A quantity.