Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Milk or colostrum
Reexamination Certificate
2000-05-09
2001-06-19
Scheiner, Laurie (Department: 1648)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Milk or colostrum
C424S157100, C099S452000, C099S496000
Reexamination Certificate
active
06248366
ABSTRACT:
The present invention relates to dairy compositions and, more particularly, to dairy compositions containing colostrum.
Raw milk contains between 0% and 1.0% immunoglobulin. However, for safety reasons milk for human consumption is pasteurised—typically at 72° C. for 15 seconds or 132° C. for at least one second (UHT). Each of these heat treatments is sufficient to denature the immunoglobulin found in raw milk and also to denature certain other milk proteins such as, for example, certain growth factors.
The maximum cfu/mL allowed in milk (Australian Food Standard H1) that has been pasteurised according to the accepted methods is 50,000 cfu/mL. In practice the counts in pasteurised milk at time of manufacture are usually less than 10,000 cfu/mL.
Colostrum is the secretion obtained from female mammals just before and for a short period after giving birth. Raw colostrum contains up to 10% immunoglobulin as well as other proteins such as growth factors. However, colostrum is routinely excluded from milk processing due to its very different composition which negatively affects processing efficiency and dairy product quality. Raw colostrum cannot be added to milk products for human consumption due to its bioburden. Colostrum cannot be pasteurised by standard methods without denaturing biologically active proteins such as antibodies. When subjected to heat treatment of greater than approximately 65° C., colostrum will typically undergo sever chemical change leading to the failing of dairy processing equipment.
It is an object of the present invention to overcome, or at least alleviate, one or more of the difficulties or deficiencies associated with the prior art.
The applicant has discovered that colostrum can be processed so as to reduce the bioburden of liquid colostrum while retaining the biological activity of certain proteins including the immunoglobulin fraction. By this process it is possible to introduce liquid colostrum into pasteurised and unpasteurised dairy products including, for example, milk, skim milk, flavoured milks, other modified milks, yoghurts (natural, flavoured, drinking, frozen), other probiotic formulations, cheese formulations such as cheese sticks, and ice creams.
Accordingly in a first aspect of the present invention there is provided a process for the preparation of a liquid colostrum product, suitable for inclusion in dairy products, which process includes subjecting colostrum to centrifugation to substantially reduce the microbial content thereof.
The colostrum may be freshly harvested colostrum or frozen colostrum. The colostrum may be bovine, ovine or caprine colostrum harvested from freshly calved animals. The colostrum may be harvested using modern milking equipment. Preferably the colostrum is from one or more of the approximately first to tenth milkings after calving. The colostrum may be antibody enriched. For example the colostrum may be from a mammal hyperimmunised against specific pathogens of relevance to human or other diseases.
Specific pathogens which may be used to hyperimmunise the mammal include one or more of:
1)
Cryptosporidium enteridies,
Cryptosporidium parvum,
2)
Isoporo belli,
3)
Giardia sp,
4)
Cytomegalovirus sp,
5)
Salmonella sp,
6)
Shigella sp,
7)
Candida sp,
8)
Rotavirus,
9)
Blastocystis hominis,
10)
Herpes simplex
virus,
11)
Entero-toxigenic
E. Coli,
12)
Aeromonas sp,
13)
Mycobacterium Avium
intracellular,
14)
Yersinia entero colitica,
15)
Toxoplasma gondii,
16)
Clostridium sp.,
17)
Campylobacter jejuni/coli,
18)
Entamoeba histolytica,
19)
Human immunodeficiency virus
20)
Helicobactor pylori,
21)
Cholera sp.,
22)
Respiratory syncitial virus
23)
Heamophilus influenzea
24)
Astrovirus
25)
Adenovirus
26)
Mycobacterium spp.
27)
Calici virus
28)
Toro virus
The colostrum may be from a mammal hyperimmunised against specific proteins or enzymes such that the specific antibodies produced are of relevance in the prevention or treatment of human diseases or metabolic disorders.
The bacteria-removing centrifugation may be performed at a speed of approximately 7000-8000 rpm, preferably approximately 7400 rpm, to generate approximately 11,000 g to 14,000 g at approximately 1100 L per hour, preferably 12,000 g at approximately 1100 L per hour. An Alfa Laval Bactofuge has been found to be suitable.
Ideally, it is preferable that the centrifugation is performed by controlling throughput and thereby residence time of the colostrum such that the microbial content is reduced to less than 500 organisms per ml, preferably 200 organisms per ml, most preferably less than 50 organisms per ml.
Preferably, the centrifugation is conducted at a temperature of approximately 50° C. to approximately 64° C. More preferably, the centrifugation is conducted at a temperature of approximately 55° C. to approximately 63° C.
Following centrifugation, the colostrum may be chilled to below approximately 10° C., preferably to below approximately 4° C.
In a preferred form, the process of this aspect of the invention may include the preliminary step of separating the colostrum. Preferably the colostrum is separated into a light phase (cream) and a heavy phase (skim) Preferably the light phase is discarded and the heavy phase is processed according to the present invention.
Any suitable separation apparatus may be used. A preferred separation apparatus is a self desludging type apparatus.
Preferably the colostrum is pre-heated to a temperature of approximately 50° C. to approximately 64° C., more preferably approximately 55° C. to approximately 63° C., for a period of approximately 3-60 minutes, more preferably approximately 30 minutes, post the separation step. Any suitable means may be used to preheat the colostrum, for example a plate heat exchanger.
It will be understood that the steps of the process of this aspect of the present invention may take place in any suitable order. Other steps may also be included in the process of the present invention. For example in preferred embodiment of the process casein is removed from the colostrum by precipitation. Preferably this step takes place after the colostrum has first been subjected to a separation step and the light phase has been discarded, and then subjected to centrifugation according to the present invention.
In a further preferred embodiment of the process the colostrum is concentrated by means of ultrafiltration and/or evaporation and/or reverse osmosis. Preferably this step takes place after either the centrifugation or, if relevant, after the casein removal.
In a still further preferred embodiment of the process the colostrum is sterile filtered. Preferably this step takes place after the casein removal.
The method according to the present invention gives results that are consistently better than the results gained with standard pasteurisation and allows for the addition of colostrum to pasteurised dairy products and/or the processing of dairy products including a colostrum component with little or no diminution of the shelf life/stability expected with normal dairy products. For example, colostrum may be added to dairy products including raw or pasteurised whole milk, skim mil, or modified milk products including flavoured milks, and the resulting mixture processed as described above.
Applicant has found that the total microbial count in liquid colostrum treated according to the process of the present invention is reduced by at least approximately 80%, preferably at least approximately 90%, more preferably at least approximately 95%. For example, a combination of gentle heat treatment at 55° C. and bactofugation typically renders a minimum 99% reduction in total microbial count. Moreover, a substantial proportion of the antibodies and/or growth factors in the liquid colostrum produced according to the method of the present invention remain undenatured following the treatment.
Because of the high concentration of immunoglobulin in the fresh, processed colostrum, only a relatively small proportion of colostrum is required to be added to milk or dairy products to bring the resulting product up to the level o
Ladas and Parry
Northfield Laboratories Pty Ltd.
Scheiner Laurie
LandOfFree
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