肿瘤坏死因子α（人类rDNA衍生）

  【编号】：NIBSC17/232

  【产品名称】：肿瘤坏死因子α（人类rDNA衍生）

  【规格】：个

  【价格】：2600元

　　肿瘤坏死因子α（人类rDNA衍生）

　　编号：NIBSC17/232

　　英文：Tumor Necrosis Factor alpha (human rDNA derived)

1. INTENDED USE

The preparation coded 17/232, prepared using the same lot of TNF-α as

the 3rd WHO International Standard for TNF-α (12/154), was established

as the NIBSC Working Standard for human Tumour Necrosis Factoralpha

(TNF-α) following an assessment of its suitability in TNF-α

bioassays, and assignment of unitage relative to 12/154 in a multicentre

collaborative study.

This preparation is mainly intended for use as a critical reagent in

bioassays for anti-TNF-α products, but can also be used for calibration of

TNF-α bioassays and immunoassays as appropriate.

2. CAUTION

This preparation is not for administration to humans or animals in

the human food chain.

The preparation contains material of human origin, and either the final

product or the source materials, from which it is derived, have been

tested and found negative for HBsAg, anti-HIV and HCV RNA. As with

all materials of biological origin, this preparation should be regarded as

potentially hazardous to health. It should be used and discarded

according to your own laboratory's safety procedures. Such safety

procedures should include the wearing of protective gloves and

avoiding the generation of aerosols. Care should be exercised in

opening ampoules or vials, to avoid cuts.

3. UNITAGE

The preparation has been assigned a potency of 42,607 International

Units of biological activity per ampoule (expanded uncertainty 40,720 –

44,582 calculated on a log scale with coverage factor k=2.36

corresponding to a 95% level of confidence). The unitage was assigned

relative to the 3

rd WHO IS for TNF-α (12/154) in a multicentre collaborative

study, and is therefore in continuity with the current IS.

4. CONTENTS

Country of origin of biological material: United Kingdom.

Each ampoule contains the residue after freeze-drying of 1.0 ml of

Phosphate Buffered Saline containing:

TNF-α, approximately 1 microgram

1 mg Trehalose

0.6% Human Serum Albumin

The TNF-α protein was expressed in E.coli.

5. STORAGE

For economy of use, it is recommended that the solution be sub divided

into several small aliquots and stored at -40ºC or below. Avoid repeated

thawing/freezing. Unopened ampoules should be stored at -20ºC.

Please note: because of the inherent stability of lyophilized

material, NIBSC may ship these materials at ambient temperature.

6. DIRECTIONS FOR OPENING

DIN ampoules have an 'easy-open' coloured stress point, where the

narrow ampoule stem joins the wider ampoule body. Various types of

ampoule breaker are available commercially. To open the ampoule,

tap the ampoule gently to collect material at the bottom (labelled) end

and follow manufactures instructions provided with the ampoule

breaker.

7. USE OF MATERIAL

No attempt should be made to weigh out any portion of the freeze-dried

material prior to reconstitution

Dissolve the total contents of the ampoule in 1.0ml of sterile distilled water.

This solution will contain TNF-α at a concentration of 42,607 International

Units/ml (see section 3). Use carrier protein where extensive dilution is

required.

8. STABILITY

Reference materials are held at NIBSC within assured, temperaturecontrolled

storage facilities and they should be stored on receipt as

indicated on the label. This standard has been produced according to

WHO specifications and as per WHO policy an expiry date has not been

assigned. Accelerated degradation studies have indicated that this

material (same as 3

IS for TNF-α) is suitably stable, when stored at -

20ºC or below, for the assigned values to remain valid until the material is

withdrawn or replaced. These studies have also shown that the material

is suitably stable for shipment at ambient temperature without any effect

on the assigned values. Once reconstituted, diluted or aliquoted, users

should determine the stability of the material according to their own

method of preparation, storage and use. Users who have data

supporting any deterioration in the characteristics of any reference

preparation are encouraged to contact NIBSC.

9. REFERENCES

This standard was produced under WHO guidelines cited in the WHO

Technical Reports Series, No. 932, 2006, Annex 2.

Report on a Collaborative study for proposed NIBSC Working standard for

Tumor Necrosis Factor - alpha (TNF-α) can be found here:

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肿瘤坏死因子α（人类rDNA衍生）

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