AU644468B2 - Colostrum preparation - Google Patents

Description

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AUSTRALIA

Patents Act 644468 COMPLETE SPECIFICATION

(ORIGINAL)

Class Int. Class Application Number: Lodged: Complete Specification Lodged: Accepted: Published: Priority 0 0 o eq o o0 00 0 0-4 0 00 0 0 00 0o o o oo 0d 00 0 00 0 4 0 0 00 o oao o* 0 0 4 4

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Related Art: APPLICANT'S REF.: Name(s) of Applicant(s): Address(es) of Applicant(s): Actual Inventor(s): MINISTER OF AGRICULTURE 19th Floor, Grenfcll Centre, 25 Grenfell Street, Adelaide, South Australia 5000, Australia Peter Bennett Duff Whyte 147 Sixth Avenue Royston Park, South Australia Australia PHILLIPS, ORMONDE AND FITZPATRICK Patent and Trade Mark Attorneys 367 Collins Street Address for Service is: Melbourne, Australia, 3000 Complete Specification for the invention entitled: "COLOSTRUM PREPARATION ANT-GTORACE"- Theflowing statement is a full description of this invention, including the best method of performing it known to applicant(s): S P'19/3/84 1 i -2- This invention relates to a process for the preparation and storage of colostrum products. It is particularly applicable to preparing and storing antibody enriched colostrum without loss of the antibody activity.

Colostrum is the milk secreted by a mammal just before and for a short period after giving birth, containing antibodies to protect offspring against disease. It has been recognised in the prior art that mammals such as cows may be immunized with specific antigens. The antibody enriched colostrum may then be harvested.

A difficulty in the prior art has been that there has been no economical process for preparing and storing colostrum products.

It is known in the prior art that milk products S may be spray dried to give a powdered product which may be .stored. When known spray drying processes were used to Sprocess colostrum it was unexpectedly discovered that the Shigh salt content of the colostrum was a problem which rendered known processes uneconomical.

Colostrum has an extremely high salt content. If known spray drying processes are used to process colostrum the spray drier must undergo extensive cleaning every day for approximately 10 hours to prevent corrosion of the drier. As indicated above this renders the process S, uneconomic and is a problem which does not relate to normal milk.

Accordingly, it is an object of the present invention to overcome or at least alleviate, one or more S 30 of the difficlIties related to the prior art.

Accordingly as a first aspect of the present invention there is provided a process for the preparation of a colostrum product which process includes: -p r ov-i-i ost removing r substantially reducing the salt content of said colost and subjecting the lostrum to a spray drying 3 9 fp hhess.

3 Tjh-eixinp-nr hamvP fnr Pf-- the-Step o-r ova1providing colostrum; subjecting the colostrum to an ultra-filtration process to remove or substantially reduce the salt content of said colostrum; and subjecting the ultra-filtered colostrum retentate j to a spray drying process, with the proviso the the colostrum is not treated with acid to adjust pH to 5.0-6.0 and with rennin or pepsin to separate casein.

The product so formed is provided in a preserved form without loss of antibody activity.

The inventors have found that the step of removal a 0 o 0 0 0 0 ft 2A L -3of salt from the colostrum renders the process economic.

Salt removal is significant as it reduces the likelihood of corrosion damage to stainless steel plant and reduces the necessity to wet wash drying equipment, offering a significant saving of time and money.

The colostrum may be freshly harvested colostrum S frozen colostrum. The colostrum may be bovine colostrum harvested from freshly calved cows. The colostrum may be harvested using modern milking equipment. The colostrum may be antibody enriched.

-he a -salt -may -be-removed by any s u-itab-1e- -R4an s In a preferred embodiment the salt is re 6 ved by ultra-filtration.

Accordingly in a further aspect 'f the present invention, there is provided a process or the preparation S of a colostrum product which processi ncludes o, providing colostrum; subjecting the colos um to an ultra-filtration process; and 20.: subjecting the filtered colostrum to a spray *drying process.

The pro ct so formed is provided in a preserved foxrrimwit-hp t i b Q 4y a -tV-ty The ultra-filtration apparatus preferably removes o..oo all molecules of molecular weight less than 20,000 for example water, minerals, salts and non-protein nitrogen.

Any suitable ultra-filtration apparatus may be used. In a preferred embodiment a hollow fibre ultra-filtration plant is used. The ultra-filtration step may also remove or reduce the lactose from the content of the colostrum.

This is also advantageous from a medical point of view.

In a preferred aspect of the present invention the process may further include the preliminary step of pasteurisation. Low temperature, long time pasteurisation is preferably employed due to the extreme heat sensitivity of immuno-proteins. In a preferred embodiment the pasteurisation is conducted at approximately 63 0 C for approximately 30 minutes. The pasteurised colostrum is '9 .then preferably cooled to approximately 55°C before

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A, A6 :7 _L ~L C- 1 -4iundergoing the ultra-filtration step. The pasteurised i colostrum may suitably be cooled by regeneration.

thbe cooled Accordingly, a further aspect of the present invention provides a process for the preparation of a colostrum product which process includes providing colostrum; subjecting the colostrum to a pasteurisation process; subjecting the pasteurised colostrum to an io ultra-filtration process; and subjecting the filtered colostrum to a spray i drying process.

I In a further preferred aspect of the present invention the process may further include the preliminary step of separating the colostrum. The colostrum may be i preferably separated into a light phase (cream) and a heavy phase (skim). The light phase is preferably i discarded.

Accordingly yet a further aspect of the present invention provides a process for the preparation of a colostrum product which process includes providing colostrum; subjecting the colostrum to a separation step and discarding the light phase; subjecting the heavy phase colostrum to a pasteurisation process; subjecting the pasteurised colostrum to an ultra-filtration process; and subjecting the filtered colostrum to a spray drying process.

Any suitable separation apparatus may be used. A suitable separation apparatus is a self desludging type apparatus.

The colostrum is preferrably pre-heated to approximately 50 0 C prior to the separation step. Any suitable means may be used to preheat the colostrum, for example by means of a plate heat exchanger.

After the ultra-filtration step, it is preferred 39 that the ultra-filtered retentate is subjected to an .i u- ri._ .L _r L- I I evaporation step in which excess moisture is removed from the retentate. In a preferred embodiment, the excess moisture is boiled off under a vacuum of approximately -100kpa. At this pressure, the vapour temperature is maintained at approximately 45 0 C thus minimising any heat damage. Any suitable evaporator may be used. In a preferred embodiment a centritherm evaporator is used.

The concentrate may then be introduced into the spray drying chamber. The concentrate may be introduced at the same temperature at which pasteurisation has occured. In a preferred embodiment it is introduced at a temperature of 63 0 C. A two-fluid nozzle may be used to introduce the concentrate into the drying chamber. In a preferred embodiment, the drying chamber is maintained at approximately 1700C inlet temperature and 70 0 C outlet temperature. The Applicants have unexpectedly found that this drying technique whichk normally be expected to inactivate the antibodies, has been found by the Applicants not to do so. Most of the energy of the spray drying is taken up as latent heat of evaporation, and S accordingly there is very little particle temperature elevation. Accordingly heat damage is minimised. The dried particles preferably fall into a static fluidised bed where further drying and fines agglomeration take place. This produces a product with good dispersibility S in water.

It will be understood that the steps of the process of the present invention as described above may take place in any suitable order. Other steps may also be included in the process of the present invention. For example in another preferred embodiment of the present application casein is removed from the milk by precipitation. This step preferably takes place after the colostrum has been subjected to a separation step and the light phase has been discarded.

The present invention will now be more fully described with reference to the accompanying drawings and example. It should be understood, however, that the description fullowing is illustrative only, and should not L i_ be taken in any way as a restriction on the generality of the invention described above.

In the drawing: Figure 1 is a flow diagram of the process according to one embodiment of the present invention. The meanings of the abbreviations and symbols in the Figures are as follows:

SEP

PAST 1 UFS-1 CT.13 P3 HEATER HT1 HT2 HT3

SEPARATION

PASTEURISATION

ULTRAFILTRATION

ULTRAFILTRATION

CENTRITHERM (Thermal Evaporator) PLATE HEAT EXCHANGER HOLDING TUBES HOLDING TUBES HOLDING TUBES 4 t I 4 I t t t *4 a 0 4 oi a 44 a 6 a a o o4 o a iP o a. t o 6 4 0I 4 4444 a rI I t ft 1. i a- 5A tr:; the inventinydescribed above.t the inventionescribed above.

EXAMPLE 1 Antibody enriched bovine colostrum was harvested from freshly calved cows using modern milking equipment.

The colostrum was quickly cooled and held under refrigeration (<4 0 C) until it was collected. The colostrum was collected daily in a refrigerated van (0 0 Colostrum from individual farms was segregated to prevent cross-contamination.

o. The colostrum was weighed and tested for o microbial quality, inhibitory substances and for specific a o antibodies to known pathogens. The colostrum was then o 0 o° o stored at 0 C pending the results of these tests.

D*O The liquid colostrum was pooled according to OO. antibody content, to produce a uniform product. The pool was kept refrigerated prior to processing.

The pooled colostrum was pre-heated to 50 0 C by means of a plate heat exchanger and separated in a self desludging type separator. The light phase (cream) was discarded and the heavy phase (skim) was pasteurised at 630C for 30 minutes. The pasteurised skim was cooled by regeneration to The skim was passed through a hollow fibre ultra-filtration plant to remove molecules of molecular weight less than 20,000; namely water, lactose, minerals, salts, non-protein nitrogen. The ultra-filtered retentate was transferred to a centritherm evaporator where excess moisture was boiled off under a vacuum of -100kpa. After evaporation, the concentrate underwent a further pasteurisation step at 63 0 C for 30 minutes to reduce microbial loading prior to spray drying.

The concentrate, at 63 0 C, was introduced into a 39 spray drying chamber of aseptic design with hepa filters *v: -7in the feed line, atomising air, and drying air supply, purpose built for pharmaceutical grade products. The concentrate was introduced via a two-fluid nozzle where it was atomised by heated, hepa-filtered air. The drying chamber was maintained at 220 0 C inlet temperature and 70 0

C

outlet temperature. The dried particles fell into a static fluidised bed where further drying and fines agglomeration took place, producing a product with good dispersibility in water. The finished product was then packaged.

EXAMPLE 2 Antibody levels and quantities of colostrum collected from cows varies dramatically over the first week after calving. The colostrum from the first six milking was collected. For practical handling reasons all o milk collected on one day was pooled at each farm with ,o each farms milk kept separate by collection date. Each of SI' these milk de. was kept separate and assessed individually for qu.ality. Colostrum delivery is shown to be satisfactory with respect to microbial and inhibitory S substances tests where pooled on the basis of quantity and haemagglutination inhibition (HAI) titre to produce a standard weight average HAI titre. This pooling step ensured that a standard product was consistently produced with respect to both the colostrum composition and antibody potency.

Approved milk pooled for processing to provide correct antibody levels was processed by skimming in a cream separator to reduce fat, low temperature pasteurisation to reduce microbiological load and eliminate major potential pathogens, ultra filtration to concentrate protein and reduce lactose and mineral levels, including salt, evaporation under vacuum to further concentrate, and spray drying in an aseptic, pharmaceutical model spray drier with filtered air supply. Powder was packed in new food grade poly-ethylene bags within new fibre-board containers and sealed for transport.

39 Table 2 illustrates a production flow chart.

L_ i i -8- TABLE 2 I* 4.d 4 o 0o Production Flow Chart: Milk Receival Pool raw milk Separation to remove cream Pasteurization 63°C for 30min Raw milk is received, weighed and stored pending quality control and release.

Approved milk is pooled according to age and potency to produce a homogeneous batch of standard potency.

Cream (milk fat) is removed by separation in a standard dairy separator.

Milk is heated to 63 C and held for 30 minutes in a standard pasteurisation process, to eliminate pathogens and reduce total microbial load.

Product is concentrated by reduction of water, lactose and electrolyte levels through ultrafiltration membrances.

Product is further concentrated by low temperature evaporation under vacuum.

Product is spray dried in an aseptic spray drier.

aca 9 0 4 0 4 4 1 A Ultrafiltration Thermal evaporation under vacuum Spray drying

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c I Bulk quality control Packing -9- Product is held in quarantine until approved for microbiological quality, moisture level and potency.

Approved bulk product packed into sachets. Packed product is returned for quality control.

Packed product is held in quarantine until approved for microbiological quality, moisture level, pack quality, potency and documentation review.

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1LU Finished Pack Quality Control I I EXAMPLE 3 Table 3 lists the constituents of a sample of colostrum product which has been prepared by the process of Example 1.

TABLE 3 0 S Moisture Fat Solubility Index Sc.Pts./Ext. Matter Protein (TN x 6.38)% Lactose Ash 500 0

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Salt Whey Protein Nitrogen mg/g Dispersability% Wettability (Secs) 25°C Aluminium mg/kg Penicillin Other Inhibitory Substances (As Pencillin I.U./mL) (I.U./mL) Colostrum Product Prepared by Process of Example 1 8.2 2.4

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73.6 11.2 5.9 0.48 60+,60+,60+ 3.4 <0.0025 <0.0025 ii_~l ii The above process reduces salt content by a factor of approximately eight times. First colostrum contains approximately 32 mmol/L of NaCl. If concentrated fold as in the process described the salt content of the powder would be 640 mmcl/kg, which is equivalent to 3.7% of the total weight. This concentration of sale could seriously affect the stainless steel surfaces of the spray drier.

The process described reduces the salt content from 3.7% to less than 0.5% of the final powder, significantly reducing the risk of corrosion, and negating the need for frequent wet cleansing procedures as described.

Finally, it is to be understood that various other modifications and/or alterations may be made without departing from the spirit of the invention as outlined herein.

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Claims (9)

1. A process for the preparation of a colustrum product which process includes providing col:strum; subjecting the colostrum to an ultra-filtration process to remove or substantially reduce the salt content of said colostrum; and subjecting the ultra-filtered colostrum retentate to a spray drying process, with the proviso that the colostrum is not treated with acid to adjust pH to 5.0-6.0 and with rennin or pepsin to separate casein.

2. A process as claimed in Claim i. wherein a hollow fibre ultra-filtration apparatus is used.

3. A process as claimed in Claim 2 wherein said ultra-filtration process removes substantially all molecules of molecular weight less than about 20,000.

4. A process as claimed in any preceding claim wherein the ultra-filtration process removes or reduces the lactose content of the colostrum. A process as claimed in any preceding claim l further including subjecting the colostrum to a pasteurisation process.

6. A process as claimed in Claim 5 wherein the pasteurisation process takes place prior to the v ultra-filtration processs.

7. A process as claime in Claim 5 or 6 wherein the process further includes separating the colostrum into a light phase and a heavy phase, the light phase being discarded. 4 8. A process as claimed in Claim 7 wherein the separation step takes place prior to the pasteurisation process.

9. A process as claimed in any preceding claim wherein the ultra-filtered colostrum retentate is subjected to an evaporation step to remove excess moisture therefrom,. A process as claimed in Claim 1 substantially as hereinbefore described with reference to any one of the examples or drawing. i 1 -11- VK 2>A I'll

11. A colostrum product produced by the process of any preceding claim. DATED: 30th September, 1993 PHILLIPS ORMONDE FITZPATRICK Attorneys for: MINISTER OF AGRICULTURE 5807G r A 01 9 00 0 000 00 0 0 0o 0 00 0 0 00 0 00 0 000 0 00 0 0 tO O 00 0 0 0 0 00 0 0 00 00 00 00 0 0 0 0 0 0 0

12- ABSTRACT SA process for the preparation of a colostrum product which process includes: providing colostrum; removing or substantially reducing the salt rf content of said colostrum; and subjecting the colostrum to a spray drying I process. A i t i