| HS Code | 582495 |
| Product Name | Transfer Factor Veterinary Grade API |
| Api Form | Active Pharmaceutical Ingredient |
| Suitable Dosage Forms | Tablets; Injections; Capsules; Powders; Granules; Premix; Solutions |
| Active Substance | Transfer Factor (low molecular weight dialyzable leukocyte extract) |
| Source | Bovine colostrum |
| Appearance | White to off-white powder |
| Solubility | Freely soluble in water; practically insoluble in organic solvents |
| Molecular Weight | 3500-10000 Dalton |
| Purity | ≥98% (HPLC) |
| Ph 1 Aqueous Solution | 6.0-7.5 |
| Storage Conditions | Store in a cool, dry place at 2-8°C, protected from light and moisture |
| Shelf Life | 24 months |
| Immunological Activity | Enhances cell-mediated immunity and transfers antigen-specific immune responses |
| Target Species | Cattle, swine, poultry, dogs, cats, sheep, and goats |
As an accredited Transfer Factor Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Sealed, light-resistant laminate pouches with tamper-evident closure, available in 1 kg quantity for veterinary API formulations. |
| Container Loading (20′ FCL) | One 20′ FCL containing palletized, drummed Transfer Factor Veterinary Grade API, secured for transport, suitable for tablets, injections, capsules, and premix forms. |
| Shipping | Transfer Factor Veterinary Grade API is shipped in sealed, inert, moisture-proof containers to preserve potency across tablets, powders, premixes, and solutions. Temperature-controlled logistics are recommended; protect from light and humidity. Full documentation, including COA and MSDS, accompanies each batch, ensuring regulatory compliance and safe delivery. |
| Storage | Store in a cool, dry, well-ventilated area at 2–8°C, protected from light, moisture, and strong oxidizers. Keep in tightly sealed, labeled original containers, away from food and animal feed. Avoid freezing or excessive heat. Use clean utensils and follow handling precautions to prevent contamination and preserve potency. |
| Shelf Life | Shelf life is typically 24 months from manufacture when stored in original sealed containers, protected from heat, moisture, and light. |
Transfer Factor Veterinary Grade API is typically supplied as a sterile-filtered, lyophilized dialysate of low-molecular-mass peptides, oligoribonucleotides and trace carrier excipients. Incoming quality control must assign a moisture limit by Karl Fischer titration, a bioburden limit and an endotoxin limit before the material is released for oral, injectable or feed-stage processing. The lyophilized cake is hygroscopic and should be handled at or below 30% RH; exposure above 60% RH for more than 2 h can produce a sticky, poorly flowing mass that will not blend uniformly with direct-compression excipients. Because no harmonized pharmacopoeial monograph exists for transfer factor veterinary grade, each downstream format relies on the general chapters and VICH/ICH quality standards applicable to the finished dosage form, and the manufacturer must justify all acceptance criteria from dosage-specific risk assessments.
A direct-fill capsule and tablet line handling this API must first address moisture sorption before blending because the lyophilized dialysate is friable at low humidity but becomes cohesive above 5% residual water. Canine and feline immune-support formulations typically combine the API at 10–50 mg of low-molecular-mass peptide fraction per unit with microcrystalline cellulose, dicalcium phosphate dihydrate, croscarmellose sodium and magnesium stearate. The exact active mass is supplier-specific and published compendial data for this peptide fraction in companion animals are limited. The API is pre-conditioned in a fluid-bed dryer at an inlet air temperature not exceeding 45°C to preserve peptide integrity, then passed through a 30-mesh stainless-steel screen before loading into a 500–1000 L V-blender or bin blender operating at 10–12 rpm for 20–25 min. Blend uniformity is verified by stratified thief sampling at 10 positions with a target relative standard deviation not more than 5% in active marker recovery. Compression is performed on a rotary tablet press at a main compression force of 8–18 kN to produce tablets with hardness from 8 kp to 12 kp, or the blend is filled into size 3 hard gelatin capsules on a capsule filler with fill-weight variation below ±5%. The terminal dosage form is tested for disintegration not more than 30 min in water at 37°C using USP <701> or Ph. Eur. 2.9.1, and packaged in PVC-PCTFE aluminium blisters or HDPE bottles with desiccant to keep headspace moisture below 25% RH. Regulatory status is not harmonized; in the United States, transfer factor for companion animals is generally not approved as a new animal drug under 21 CFR 510, so the product is commonly positioned under feed-ingredient or supplement provisions with label claims limited accordingly.
Because terminal steam sterilisation at 121°C for 15 min would degrade low-molecular-mass transfer factor peptides and oligoribonucleotide components, multi-dose bovine injectable processing must use an aseptic filtration route. The lyophilized API is first reconstituted in Water for Injection with 0.9% sodium chloride or phosphate-buffered saline, adjusted to pH 7.0–7.4, and clarified through a 0.45 µm pre-filter followed by a 0.22 µm PVDF or PES sterilising-grade membrane. The solution is held at 2–8°C during aseptic filling, and maximum sterile hold time before filtration is typically validated at not more than 4 h because bioburden proliferation in a peptide-containing solution can raise endotoxin levels even if the final membrane removes intact microorganisms. The final container is a Type I glass vial or multilayer plastic vial with chlorobutyl rubber closures, flushed with nitrogen to reduce oxidative peptide modification. Endotoxin acceptance is derived from the dose administered; for a 500 kg bovine receiving a 10 mL dose, a limit of 5 EU/kg yields a maximum allowable concentration of 250 EU/mL, documented according to USP <85> or Ph. Eur. 2.6.14. Particulate matter is controlled to USP <788>, and sterility is confirmed by membrane filtration using USP <71>. A peptide concentration in the range of 1–10 mg/mL is preferred because higher concentrations may increase turbidity and aggregation risk during storage at 2–8°C. Published data on transfer factor veterinary injectables are limited; each manufacturer must perform forced-degradation studies at pH 3, 5, 7 and 9 to justify the registered shelf-life.
| Parameter | Method or equipment | Acceptance window |
|---|---|---|
| Bacterial endotoxin | USP <85> / Ph. Eur. 2.6.14 | Dose-dependent; 5 EU/kg; ≤250 EU/mL for 10 mL dose in 500 kg cattle |
| Sterility | USP <71> membrane filtration | No growth after 14 days |
| Particulate matter | USP <788> light obscuration | ≥10 µm NMT 6000/container; ≥25 µm NMT 600/container |
| pH | Calibrated pH meter | 7.0–7.4 |
| Osmolality | Freezing point osmometer | 280–320 mOsm/kg |
A 10% active granular premix for nursery pigs is usually manufactured by spraying a preserved liquid transfer factor concentrate onto a pre-conditioned lactose-maltodextrin carrier in a horizontal ploughshare mixer. A common spray-dilution ratio is 1 part liquid concentrate to 9 parts carrier by mass, producing a 10% active premix that is subsequently let down in a double-ribbon mixer to a final complete-feed addition of 0.5–2.0 kg per metric tonne. The critical process point is carrier moisture: lactose-maltodextrin above 8% moisture causes bridging and granule segregation, while below 3% moisture can generate electrostatic dust. Liquid addition rate is controlled at 200–300 mL/min for a 500 kg batch with the ploughshare rotor at 100–120 rpm; after spraying, the mass is passed through a 3 mm fluid-bed granulator or wet-milled and dried at an inlet air temperature not exceeding 50°C to a final moisture below 5%. Homogeneity is verified by tracer salt or active peptide assay at 10 sample points, with a relative standard deviation not more than 10% as a common feed-mill homogeneity target under Regulation (EC) No 183/2005 feed hygiene principles. Because transfer factor is not listed as an authorised zootechnical additive under Regulation (EC) No 1831/2003, the finished premix may be restricted to national legal categories and manufacturers must verify feed-additive status before labelling for disease prevention. The terminal product is a free-flowing 20 kg bagged premix with mineral oil sealing to reduce dust, stored at 15–25°C because residual spray-dried peptide material is deliquescent above 65% RH.
When freeze-dried transfer factor API is post-blended into poultry drinking-water powders, the dissolution profile depends on the ionic composition and biocide load of the water line. Hard water containing more than 150 ppm calcium carbonate equivalent and free chlorine residual above 3 ppm can reduce measurable peptide activity through oxidative modification or metal-catalysed cleavage; therefore citric acid or EDTA is dry-blended at 0.2%–0.5% of the finished powder formula. A typical drinking-water powder contains API, dextrose monohydrate, citric acid and a flow aid, dry-blended in a ribbon mixer for 15–20 min. The target in-use solution is commonly 1–2 g of powder per 10 L of drinking water, but no harmonised veterinary pharmacopoeial potency assay exists for transfer factor, so label dosing must be derived from manufacturer-specific batch data and not extrapolated from mammalian injectable doses. The blended powder should pass completely through a 60-mesh screen, with residue not more than 2%, and must be packed in aluminium-foil-lined sacks to limit moisture ingress. Poultry producers using high-output nipple drinkers should pre-dissolve the powder in a 200 L stock tank and allow 10 min mixing before diversion into the medicator; direct dry addition into a closed line usually causes sediment in pressure regulators if soluble mineral hardness exceeds 200 ppm. Because the API may be susceptible to chlorine, the stock tank should be filled with water that has passed through a granular activated carbon filter, and pH should be held between 5.5 and 7.0 to avoid peptide denaturation. This route is used mostly during vaccination intervals or post-transfer stressors, but published peer-reviewed efficacy data for transfer factor in poultry remain limited.
In equine geriatric and transport-stress feeding systems, the API is usually dry-blended into a dextrose, apple pomace or alfalfa meal carrier at a concentration that delivers a single daily oral dose within 10–20 g of product. The main process constraint is palatability rather than dissolution, because horses may reject bitter peptide fractions above a threshold; this is managed by fluid-bed granulation with a 2%–3% aqueous maltodextrin binder and a final top-dress of apple flavour or fenugreek powder. Granulation is performed at an inlet air temperature of 55–65°C, but the API is added after drying and cooling to avoid thermal exposure. The final granule is sized through a 2 mm sieve and packaged in 5 kg stand-up pouches with metallised film. Compliance is defined by relevant feed-ingredient definitions; the product should be tested for moisture using USP <921>, aerobic plate count using ISO 4833-1, and heavy metals such as lead not more than 2 ppm and arsenic not more than 1 ppm according to destination-market feed limits. Rancidity of apple pomace at storage above 35°C can destabilise peptide activity through lipid oxidation, so mixed tocopherols are added at 0.1% of the carrier before blending. Published data for transfer factor in equine immune support are limited; dose-finding relies on pilot field data and not on interpolation from other species.
Reconstituting transfer factor API into oral drench or milk replacer solutions for neonatal ruminants requires first buffering the aqueous phase to pH 6.5–7.5 before adding the peptide fraction, because acidic whey replacers down to pH 4.5 can protonate the peptide backbone and reduce activity. A typical drench composition includes sodium chloride 0.85%, sodium citrate dihydrate 0.3%, and a preservative such as potassium sorbate 0.1% when the solution is packaged in multi-dose drench containers. The API is dissolved separately in a 10 L stainless-steel vessel with gentle overhead stirring at 100–200 rpm; high-shear dispersion above 500 rpm or ultrasonic mixing is avoided because cavitation fragments low-molecular-mass peptide complexes. The solution is then filtered through a 75 µm food-grade strainer and filled into 250 mL amber HDPE drench bottles with tamper-evident caps. The terminal product must be used within 24 h after opening unless a preservative system is validated by compendial antimicrobial effectiveness testing using USP <51>. In milk replacer applications, the API should be added only after the replacer has been reconstituted and cooled to 37–40°C, as prolonged exposure above 50°C in pasteurised or re-heated milk will denature heat-labile peptide fractions. The addition level in milk replacer is commonly 1–2 g per calf per day, but published farm-scale growth or morbidity data for transfer factor in neonatal ruminants are limited.
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Transfer Factor Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is supplied as a sterile-filtered, lyophilized low-molecular-weight polypeptide fraction under product code TFV-API. The material is obtained from bovine colostrum or hyperimmune avian egg yolk and is not a single molecular entity; it is a dialysate fraction with a molecular weight below approximately 12,000 Da. Three physical designations are available. TFV-API-LYO is a milled lyophilized powder intended for tablet compression, capsule filling, sterile injection reconstitution, and oral solution compounding. TFV-API-PMX is a spray-dried premix supported on dextrose monohydrate, standardized for direct addition to milk replacers, starter feeds, and drinking water. TFV-API-STER is the sterile injectable-grade lyophilized powder with reduced bioburden and endotoxin controls. The polypeptide content of the lyophilized grade is controlled between 20.0% and 40.0% w/w by Kjeldahl nitrogen determination with N×6.25 (Ph. Eur. 2.5.33), and the premix grade is standardized to 10.0% w/w polypeptide. Residual moisture by Karl Fischer titration (USP 921 Method Ia) is not more than 3.0% for the lyo grade and not more than 5.0% for the premix grade. Bulk density measured by USP 616 Method I falls between 0.28 g/mL and 0.42 g/mL for lyo powder and between 0.55 g/mL and 0.70 g/mL for the premix. Particle size is controlled by sieve analysis (USP 786) with a d90 below 250 μm for the lyo grade and a mean particle size between 75 μm and 150 μm for the premix grade. Published data for this specific configuration is limited; the values above represent manufacturer release criteria derived from process capability runs on 25 kg batch scales.
Because no harmonized pharmacopoeial monograph exists for transfer factor of veterinary origin, release specification design follows the decision-tree principles of ICH Q6A and relevant VICH quality guidelines. Identity is confirmed by reversed-phase high-performance liquid chromatography with UV detection at 214 nm (Ph. Eur. 2.2.29); the sample chromatogram must match a qualified reference batch in at least 5 characteristic peak retention times. Peptide molecular weight distribution is examined by Tris-tricine SDS-PAGE under reducing conditions (Ph. Eur. 2.2.31) and shows principal bands between 3.5 kDa and 6.0 kDa. Potency is assessed by a validated leukocyte migration inhibition assay relative to a house reference standard; acceptance is 70% to 130% of reference activity. No international units exist for transfer factor, so the potency value is not interchangeable between manufacturers. Purity controls include residual host-cell protein by ELISA not more than 0.5% w/w, residual DNA not more than 10 ng per dose for injectable grade, and residual IgG not more than 1.0% w/w when tested against source species reference serum. Bacterial endotoxins are controlled according to USP 85 or Ph. Eur. 2.6.14; the limit is derived from the maximum intended dose and route, not assigned as a generic product constant. Residual solvents are controlled under VICH GL18 and USP 467 with ethanol not more than 5000 ppm and acetone not more than 5000 ppm in lyophilized material. Heavy metals by USP 232/233 are limited to lead not more than 10 ppm, cadmium not more than 5 ppm, and arsenic not more than 15 ppm. The total aerobic microbial count by USP 61 is not more than 102 CFU/g, total yeast and mold count by USP 61 is not more than 101 CFU/g, and Escherichia coli, Salmonella, and Pseudomonas aeruginosa are absent in 10 g by USP 62.
Viral safety is addressed through source herd certification, pasteurization at 60°C for 10 h in the presence of 10% w/v sorbitol, and nanofiltration through a 15 nm planar membrane. The clearance of a model small non-enveloped virus is validated by spiking studies according to Ph. Eur. 5.1.7; retrovirus and prion risk is mitigated by donor screening and geographical sourcing. The resulting API is free of antibiotics by microbial inhibition test (Ph. Eur. 2.6.3).
During scale-up to a fluid-bed dryer with a 120 kg bowl charge, the principal failure mode observed was agglomeration of the hygroscopic lyo powder when inlet air dew point exceeded 4°C at 25°C room temperature. The corrective control is to maintain environmental relative humidity below 45% RH and to blanket the receiver with dry nitrogen. In one campaign, tablet sticking on a 16-station rotary press was traced to a moisture excursion from 2.4% to 3.8% during a 90 min hopper hold time; installing a nitrogen-purged hopper and reducing hold time to 20 min restored acceptable ejection force and tablet hardness. The premix grade is less hygroscopic because the dextrose carrier is crystalline, but it is not suitable for direct injection or sterile compounding. For all solid dosage forms, the API is passed through a 0.5 mm comil screen at 1500 rpm before blending. Blend uniformity is verified by sampling 10 locations and quantifying the marker peptide by HPLC; acceptance is a relative standard deviation not more than 5.0%.
When the API is specified for sterile injection, the lyophilized powder is dissolved in Water for Injections, aseptically filtered through a 0.22 μm PVDF membrane, and filled into Type I borosilicate glass vials with bromobutyl rubber stoppers. Sterility is confirmed by USP 71 or Ph. Eur. 2.6.1. Particulate matter must comply with USP 788 for small-volume parenterals; subvisible particle counts for ≥10 μm and ≥25 μm are measured by light obscuration. The bacterial endotoxin limit is calculated from the maximum bolus dose; for a 2 mg/mL solution administered at 1 mL/kg to dogs, a compendial limit of 0.5 EU/mL is commonly cited, but the final monograph limit must be derived from the approved dose and route. The reconstituted solution is used within 8 h at 2–8°C; published data for longer stability in this specific formulation is limited. Lyophilized vials are stoppered under partial vacuum after a freeze-drying cycle with primary drying at −30°C shelf temperature for 20 h and secondary drying at 25°C for 6 h. The moisture content after lyophilization is not more than 3.0%. For feline or equine intramuscular formulations, the API is typically filled as a sterile powder and reconstituted with a separate diluent to avoid precipitation during terminal sterilization; terminal steam sterilization is not recommended because the peptide fraction is heat-labile in solution above 40°C.
Tablet compression and capsule filling require control of moisture, particle size, and flow. A direct-compression blend for small companion-animal tablets typically contains the lyo API, silicified microcrystalline cellulose, croscarmellose sodium, and magnesium stearate 0.5% w/w. Processing is confined to 20–25°C and 35–45% RH; tablet hardness is maintained between 5 kP and 8 kP on a Schleuniger tester. Disintegration time by USP 701 is not more than 15 min in purified water at 37°C. Capsule filling on a dosator machine is performed under nitrogen purge with inline near-infrared moisture monitoring at 1450 nm and 1940 nm. Granulation for feed premixes uses a top-spray fluidized-bed granulator with 2% w/w povidone K30 binder, inlet air at 50–60°C, and product temperature not exceeding 35°C. After drying, the granules are sieved through 850 μm and 150 μm screens to remove overs and fines. For milk replacer premixes, the spray-dried TFV-API-PMX is mixed in a low-shear ribbon mixer for 20 min; homogeneity is validated at 10 sampling points with acceptance of relative standard deviation not more than 5.0%. The premix is packaged in heat-sealed aluminum foil lined bags with desiccant and stored below 25°C. At 40°C/75% RH, published data for this specific configuration is limited; real-time stability data at 25°C/60% RH support a shelf life of 12 months. Pre-drying is required when the lyo powder is exposed to RH greater than 60% before tablet compression or capsule filling.
For aqueous solutions used in drinking water or oral drenching, preservative choice and pH control determine physical stability. Transfer factor is a complex polypeptide mixture with hydrophobic and hydrophilic domains; at pH below 4.5 or above 8.0, turbidity increases within 24 h at 25°C. The formulation is therefore buffered to pH 6.0–7.0 with 10 mM citrate or phosphate buffer. Methylparaben 0.18% w/v and propylparaben 0.02% w/v are used for oral solutions in polyethylene terephthalate bottles; sodium benzoate 0.1% w/v is acceptable only below pH 5.0, which is outside the stable pH range for this API and is therefore not recommended. Solutions are filled under nitrogen headspace into amber Type II glass or high-density polyethylene containers. Storage at 2–8°C is recommended. The product should not be combined with oxidizing agents such as hypochlorite disinfectants in drinking water because oxidative degradation of methionine and cysteine residues can reduce marker peptide recovery by more than 10% within 4 h. Published data for this specific configuration is limited; stress studies have used 0.1% hydrogen peroxide as an oxidative challenge and observed loss of the 3.5 kDa band on SDS-PAGE. Benzyl alcohol as a preservative is not recommended in neonatal animals because of increased toxicity risk; this is a species-specific safety boundary rather than a peptide stability issue.
Crude colostrum powder contains IgG, lactoferrin, casein, and variable amounts of transfer factor; its standardization is based on total IgG by radial immunodiffusion, not on the low-molecular-weight peptide fraction. This makes tablet and injection manufacturing unpredictable because the active marker is undefined and the powder is poorly compressible. In contrast, this veterinary-grade API is processed to remove immunoglobulin and high-molecular-weight proteins, yielding a defined polypeptide fraction suitable for sterile filtration and direct compression. Yeast beta-glucan products act through pattern recognition receptors and are suspensions rather than solutions; they cannot be sterile-filtered and are limited to oral or feed routes. Recombinant cytokines such as interferon or interleukin-2 are single molecular entities with species-specific receptor binding and require cold-chain handling; they are generally injectable-only and may induce neutralizing antibodies with repeated use. Transfer factor is a low-molecular-weight dialysate of donor immune information and has broader formulation compatibility across tablets, injections, capsules, powders, granules, premix, and solutions. However, because no international unit exists, cross-manufacturer potency comparisons are not valid unless the same house standard and assay are used.
| Product class | Active principle | Analytical marker | Principal limitation | Formulation compatibility |
|---|---|---|---|---|
| Crude colostrum powder | IgG, lactoferrin, casein, undefined transfer factor | Total IgG by radial immunodiffusion | Variable composition, heat-labile, poor flow | Feed and oral powder only |
| Recombinant cytokine | Single recombinant protein | ELISA, cell-based bioassay | Species-specific receptor binding, cold chain | Mainly injectable |
| Yeast beta-glucan | β-(1,3/1,6)-D-glucan | Enzymatic hydrolysis, HPSEC | Insoluble suspension, oral only | Feed and oral suspension |
| Transfer Factor Veterinary Grade API | Low-molecular-weight polypeptide fraction | RP-HPLC fingerprint, leukocyte migration inhibition | No harmonized international unit | Tablets, injections, capsules, powders, granules, premix, solutions |
| Test parameter | Method | Release control |
|---|---|---|
| Appearance | Visual inspection | White to off-white lyophilized powder or free-flowing premix |
| Polypeptide content | Ph. Eur. 2.5.33 | 20.0–40.0% w/w lyo; 10.0% w/w premix |
| Residual moisture | USP 921 Method Ia | ≤3.0% lyo; ≤5.0% premix |
| Bulk density | USP 616 Method I | 0.28–0.42 g/mL lyo; 0.55–0.70 g/mL premix |
| Particle size | USP 786 | d90 250 μm lyo; mean 75–150 μm premix |
| Microbial enumeration | USP 61 | TAMC ≤102 CFU/g; TYMC ≤101 CFU/g |
| Specified pathogens | USP 62 | Absence of E. coli, Salmonella, P. aeruginosa in 10 g |
| Bacterial endotoxins | USP 85 | Dose-derived; not a fixed product limit |
| Sterility, injectable grade | USP 71 | Sterile |
| Particulate matter | USP 788 | Meets small-volume parenteral limits |
| Residual solvents | USP 467 | Ethanol ≤5000 ppm; acetone ≤5000 ppm |
| Heavy metals | USP 232/233 | Pb ≤10 ppm; Cd ≤5 ppm; As ≤15 ppm |
