Source Plasma definition

Source Plasma means Plasma collected by apheresis;

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Source Plasma means the fluid portion of human blood col- lected and intended as source material for further manufacturing use. The definition excludes single donor plasma products intended for in- travenous use.

Source Plasma means the fluid portion of human blood col­ lected and intended as source material for further manufacturing use.

Examples of Source Plasma in a sentence

• The suit- ability of a donor for Source Plasma shall be determined by a qualified li- censed physician or by persons under his supervision and trained in deter- mining donor suitability.

• Plasma must be collected from donors who fulfill all requirements as Qualified Donors as defined by iQPP standards and in accordance with 21 CFR Part 640 Subpart G, Source Plasma Suitable Donors 640.63.

• Plasma must be collected in bottles that fulfill all requirements sited by the FDA in 21 CFR Part 640 Subpart G, Source Plasma 640.64(b).

• PPF Powder will be fractionated by NewCo from U.S. Collected Source Plasma obtained in accordance with the provisions of 21 CFR §640, Subpart G, and other applicable FDA guidelines and regulations including but not limited to 21 CFR §610.46 regarding lookback requirements.

• If FFP prepared by plateletpheresis or plasmapheresis is to be used as PSDP, then each unit must be relabeled as Source Plasma in accordance with Section 3.8 below.

• Source Plasma collection in bottles in accordance to current SOP’s of the collecting facility at the time of donation.

• For each twelve-month period thereafter, the price for Source Plasma shall be the price for the immediately prior twelve-month increased or decreased by a percentage exactly equal to the percentage by which the Weighted Average Sales Price charged by NABI to its contract customers for Source Plasma for the immediately prior twelve-month period has increased or decreased over the Weighted Average Sales Price charged by NABI for Source Plasma for the second prior twelve month period.

• Subject to the assumptions described in the Company Disclosure Letter, the Pro Forma Source Plasma Inventory consists of a quality usable by and salable to the blood plasma fractionation industry, except where the failure of such inventory to consist of such quality to be usable by and salable to the blood plasma fractionation industry would not have a Material Adverse Effect on the Company.

• Plasma must be collected as Source Plasma as defined by the FDA in 21 CFR Part 640 Subpart G, Source Plasma 640.60.

• Source Plasma must be frozen by cooling rapidly at -20ºC or colder, as soon as possible and at the latest within 24h of collection.

More Definitions of Source Plasma

Source Plasma as defined by the regulations of the Center for Biologics Evaluation and Review of the Food and Drug Administration ("FDA") and/or other applicable international, state or local authorities now or hereafter in effect (the "Regulations"), that meets the product specifications as set forth on Exhibit A, as the same may be amended from time to time (the "Specifications"), and has levels of both S. aureus and S. epidermidis antibodies satisfactory to Inhibitex in its sole discretion.

Source Plasma means the liquid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use, but does not include single donor plasma products intended for intravenous use .

Source Plasma means CMV Hyper-Immune source plasma to be delivered to Prothya, by or on behalf of Kamada or CSL in accordance with the terms set forth in the SOW and the Plasma Agreement, for the performance by ▇▇▇▇▇▇▇ of the Services.

Source Plasma means human plasma collected by plasmapheresis that is intended for use in producing a drug for human use. (plasma destiné au fractionnement)

Source Plasma means plasma that is collected by plasmapheresis and that is used in the manufacture of a drug for human use.

Source Plasma means the human anti-rabies plasma supplied by Sanofi Pasteur to BPC under the terms of this Agreement pursuant to the terms of a separate source plasma supply agreement between the parties or otherwise provided from external sources.