Engineering Run definition

Engineering Run means a Run used for process demonstration and engineering of some or all of the Manufacturing Process steps.

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Engineering Run means a fermentation run, at the same scale as the intended GMP batch, conducted for the purpose of testing a manufacturing process, identifying and resolving any potential issues with equipment or cGMP documentation prior to clinical GMP manufacturing, and supplying material for non-clinical use and/or stability studies. An Engineering Run is not for the purpose of manufacturing Product in conformance with cGMP.

Engineering Run or “ER” means a Batch manufactured with the purpose of confirming successful transfer and/or implementation of the Manufacturing Process to the Facility.

Examples of Engineering Run in a sentence

• The Manufacturing Price, Campaign Report Fee, Engineering Run Price and Annual Program Fee specified in Attachment 1 shall increase first on [***] and then on [***] of the consecutive years in an amount [***], if any, [***].

• Note: T=0 initial testing is covered in Stage 8: Engineering Run.

• The approved documentation, including the instructions for the Manufacturing of Bulk Drug Substance, the media and buffer preparation records, the ▇▇▇▇ of materials, sampling plans, and Specifications (including testing procedures), special notations, and precautions to be followed, all of which are identically reproduced for each Run (other than an Engineering Run) to assure uniformity from Batch to Batch.

• In addition, COBRA’s obligation to complete the stability program for the [****] Engineering Run ([**] stability pulls over [*********]), AUXILIUM’s obligation to pay COBRA for the stability program for the [****] Engineering Run, and all provisions relating to the Stability Pull Price and adjustments thereto, shall survive the expiration or termination of this Agreement.

• Sponsor’s representative may be present on the floor during execution of the Engineering Run.

• X Staging of GMP manufacturing suites & suite activation X Client-specific Master Batch Records X Client-specific Sampling Plans X Engineering Run Activities: 2 Months Execution of up to three (3) Engineering Run in the GMP suite using healthy donor material specified by Client.

• By way of example, and not by limitation, COBRA’s obligations to complete the stability program for the [****] Engineering Run ([**] stability pulls over [*** *******]), and AUXILIUM’s obligation to pay COBRA for the stability program for the [****] Engineering Run, shall survive termination or expiration of this Agreement.

• Promptly following the completion of an Engineering Run (or as otherwise agreed by the Parties in writing), a Process Simulation Study will be conducted as appropriate to the Project and as set forth in the SOW/Project Plan.

• Except as in the preceding sentence, Paragon shall have no obligation to repeat any Engineering Run unless Client and Paragon execute a Change Order for such additional Run and the appropriate additional costs.

• Upon execution of this PSA, Client shall issue a binding Purchase Order and SBL shall reserve capacity for [***] Engineering Run to be completed in [***], [***] to be completed in [***], and [***] to be completed in [***], each of which shall be Manufactured prior to Commercial Year 1 pursuant to Section 5(d)(i) above..

More Definitions of Engineering Run

Engineering Run means each of the first [****(*)] Batches of GTC Product purified and tested by CBSMA pursuant to the terms of this Service Agreement including any Exhibits hereto. The Engineering Runs are not intended for inclusion in the Consistency Series, but after review by GTC of the Batch records and the QC release data, GTC, in its sole discretion, may deem such Batches suitable for use in pre-clinical and clinical applications.

Engineering Run means: the process performed by SYNCO concerning the reintroduction of the manufacturing process of PTH and TEDUGLUTIDE in SYNCO's Facility, which product will be tested to confirm the Reintroduction Objectives can be met.

Engineering Run means any non-GMP batch run with or without [*].

Engineering Run means a non-cGMP Manufacturing run utilizing Master Production Records and intended to execute the series of unit operations in the specified order to evaluate whether or not the Manufacturing Process meets draft Product Specifications. For Engineering Runs raw materials and equipment will be used as for intended later cGMP manufacturing. Raw Materials for non-cGMP purpose do not require incoming goods controls, but QA release based on supplier certificates. Suppliers do not need to be audited at this stage. The Engineering runs are performed in the same cGMP clean rooms facilities and by the same trained personnel as for the intended later cGMP manufacturing. Engineering runs will not include deviations or OOS reporting in IDT’s Quality System. Engineering runs will include review by Production Record review team, QC record review team and QA, but no QP release. Product from Engineering Runs shall be considered as Development Product pursuant to Section 2.10.

Engineering Run means a Run used for process demonstration and engineering of some or all of the Manufacturing Process steps. “Fujifilm Confidential Information” shall have the meaning set forth in Section 8(b).