Clarification of transgenic milk using depth filtration
AssigneeGTC Biotherapeutics, Inc.
InventorMark Perreault
Life of this patent
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Abstract
Processes and apparati are provided for separating molecules of interest from a mixture by depth filtration (DF). The DF of the invention is useful in the clarification and processing of various feedstreams for the removal of a molecule of interest. According to a preferred embodiment, a transgenic milk feedstream is stabilized and particulate matter such as fat, casein miscelles and bacteria are removed. An aseptic filtration step was also developed to remove any bacteria remaining in a clarified transgenic milk feedstream.
Claims82
A method for separating a protein of interest from a feedstream, comprising:
- (a) filtering said feedstream by a depth filtration process that separates said molecular species of interest from said feedstream on the basis of particulate size further comprising a filter surface and a filter matrix;
- (b) performing a viral inactivation step that inactivates at least 90% of viral particles or fragments;
- (c) providing aseptic filtration for the filtered feedstream that retains said protein of interest and any accompanying contaminants;
- and,
- (d) clarifying the remaining material through additional downstream processing.
- wherein particulates are trapped both upon said filter surface and within said filter matrix.
The methods of claim 1 or 39 wherein said protein of interest is an antibody.
The methods of claim 1 or 39 wherein said protein of interest is recombinant human albumin.
A method for separating a protein of interest from a transgenic milk feedstream, comprising:
- (a) filtering said milk by a depth filtration process that separates said molecular species of interest from said feedstream on the basis of particulate size further comprising a filter surface and a filter matrix;
- (b) performing a viral inactivation step that inactivates at least 90% of viral particles or fragments;
- (c) providing aseptic filtration for the filtered feedstream that passes said protein of interest and retains accompanying contaminants;
- and,
- (d) clarifying the remaining material through downstream processing;
- wherein particulates are trapped both upon said filter surface and within said filter matrix.
The method of 39 wherein said feedstream is concentrated or diluted before depth filtration.
A method for isolating a protein of interest from a feedstream comprising:
- collecting a feedstream sample;
- diluting the feedstream with ammonium sulfate sufficient to precipitate protein contaminates, wherein the ph of the collected feedstream is above ph 5.0
- subjecting the collected feedstream to a microfiltration in a filtration unit with a mean pore size of from 1.5 um to 15 um;
- subjecting the filtrate to tangential flow microfiltration to provide molecule separation with a limit of separation of 5,000 to 50,000 daltons.
Dependencies are inferred from the claim text.