Extracted Anticoagulant Protein (NAP)
Situations that have been monitored, together with in-process acceptance standards, are listed in the course of flow diagrams ( FIGS 2-four ) Brief descriptions of the In-Course of Test Strategies are listed beneath Using a vacant web site that can be visited and inspected, Plan and design a new fitout to go well with a given brand It was agreed that after the confirmation of the total minutes, a board member would prepare a model suitable for inclusion on the auDA net web page A minimum of three days should elapse to permit board members to make comment earlier than the minutes turn out to be publicThe current invention pertains to a process for the manufacture of proteins that are anticoagulants in human plasma, and to proteins produced by this process Particularly, the current invention relates to processes for the manufacture of purified Nematode-extracted Anticoagulant Proteins (NAPs), and relates to purified NAPs manufactured by this process Specifically, the present invention pertains to NAP drug substances and NAP drug merchandise, and processes for manufacture thereof BACKGROUND OF THE INVENTION The terms “AcaNAPc2” or “rNAPc2” confer with a recombinant protein of the NAP household The preparation and sequence of AcaNAPc2 is described in US Pat No 5,866,542
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This section describes the fermentation procedures for production of rNAPc2/proline The rNAPc2/proline protein was produced as a secreted protein by Pichia pastoris The fermentation course of for rNAPc2/proline consisted of seed flasks, a seed fermentation, and a manufacturing fermentation ( FIG 2 , Fermentation Circulation Diagram) All media parts make the most of Purified Water, USP Moist Cell Weight Roughly 15 mL of fermentation samples had been added to tared microcentifuge tubes and centrifuged at 10,000 rpm for roughly 5 minutes The supernatant from every tube was decanted and the tubes containing the solids have been weighed The wet cell weight was equal to the web weight divided by the original sample volume
Alternately, the recovery course of to effectively seize NAP from the fermentation step might be carried out utilizing strategies aside from increasing-bed-ion-trade cromatography Certainly one of skill in the artwork can take a look at and evaluate alternate methods for capturing NAP and eradicating cells and mobile particles including but not limited to affinity chromotography, centrifugation, filtration, differential precipitation, and other strategies to be determined The final chromatography unit operation eliminated many of the remaining protein and non-proteinaceous contaminants from rNAPc2/proline utilizing a column of SOURCE 15Q ion trade chromatography media (Amersham Biosciences)
The bulk NAP drug substance could also be re-filtered and crammed utilizing the identical technique for ultimate filtration, eg, the contents of smaller bottles filled as described above can be transferred to a bigger container In a single embodiment, the contents of the Teflon FEP bottles containing rNAPc2/proline drug substance as described above are transferred into an autoclaved carboy in a Class one hundred area, re-filtered, and stuffed SUPPLY 15PHE Hydrophobic Interaction Chromatography The initial purification step partially purified the product by eradicating some protein and non-proteinaceous contaminants from rNAPc2/proline utilizing a column of SOURCE 15PHE hydrophobic interaction chromatography media (Amersham Biosciences)
This section describes the fermentation procedures for manufacturing of rNAPc2/proline The rNAPc2/proline protein was produced as a secreted protein by Pichia pastoris The fermentation process for rNAPc2/proline consisted of seed flasks, a seed fermentation, and a manufacturing fermentation ( FIG 2 , Fermentation Movement Diagram) All media components make the most of Purified Water, USP Wet Cell Weight Roughly 15 mL of fermentation samples have been added to tared microcentifuge tubes and centrifuged at 10,000 rpm for roughly 5 minutes The supernatant from every tube was decanted and the tubes containing the solids were weighed The moist cell weight was equal to the net weight divided by the unique sample quantity
FIG 6 depicts a lyophilized drug product formulation movement diagram showing the supplies and reagents used, process and equipment used, and situations which might be controlled and monitored in the course of the process of formulating lyophilized drug product The method includes a UF/DF step, a compounding step, a bulk filtration and fill step, and switch to the lyophilization unit DETAILED DESCRIPTION OF THE INVENTION The terms “AcaNAPc2/proline,” “AcaNAPc2P,” “rNAPc2/proline” and “rNAPc2/Professional” check with a recombinant protein having the amino acid sequence of AcaNAPc2 which has been modified so as to add a proline residue to the C-terminus of the sequence of AcaNAPc2 resources
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