Biological Control and Potency Tests

LAB Research Denmark can offer a full range of biological control and potency tests, performed according to various pharmacopoeias (European, US, Japanese and British).

The tests can be modified or expanded as required.  All tests are performed in compliance with current Good Manufacturing Practice (GMP), but can also be undertaken according to GLP.

The tests are run quickly, and results and reports are sent or faxed a very short time after the test has finished. This allows rapid release of batches of the products tested.

Test for endotoxins (LAL), gel clot and kinetic chromogenic method
The LAL-test is a test in vitro for bacterial endotoxins. It uses a lysate of amoebocytes from the horseshoe crab, Limulus polyphemus. These cells are collected from living crabs in the wild without any damage to the crab.

The gel clot method is a limit or a semi-quantitative test, and shows whether there is less or more than a stated level of endotoxin in a given solution.

The kinetic chromogenic method measures the chromophore released from a suitable chromogenic peptide by the reaction of endotoxins. The kinetic chromogenic technique is a method to measure the onset time needed to reach a predetermined absorbance of the reaction mixture.

Safety test (USP), abnormal toxicity (Ph. Eur.), test for abnormal toxicity (BP)
This in vivo test is intended to detect any unexpected or unacceptable biological reactions. The test is required for the safety assessment of biotechnology-derived products and biologics. For biotechnology-derived products, the test is performed in mice, while the test for biologics (immunosera and vaccines) is conducted in both mice and guinea pigs. There are minor differences in performing the test, depending on which pharmacopoeia is relevant to the product to be tested.

Heparin potency (Ph. Eur.)
The anticoagulant activity of heparin is determined in vitro by comparing its ability to delay the clotting of recalcified citrated sheep plasma with that of a reference preparation of heparin calibrated in International Units.  LAB Research Denmark has developed a very effective test system, including a statistical computer programme for calculation of the result. This facilitates determination of the potency of heparin preparations quickly and precisely.

We can also perform the Identification A test described in the European Pharmacopoeia. This test involves adding freshly collected blood from pigs to either a heparin solution or a solution of 0.9 % saline. The time until coagulation is measured.

Test for pressor substances (e.g. vasopressin, oxytocin)
This test involves measurement of the rise in blood pressure in anaesthetised rats or cocks, induced by an intravenous injection of a standard hormonal preparation. (Eighteen hours before the test, the animal is given an alpha-blocker). The rise in blood pressure is compared with the effect of the test product.

Test for potency of human growth hormone
This test involves measurement of the increase in body weight of hypophysectomised rats after subcutaneous injections of standard or test human growth hormone preparations.

Mouse bioassay for algal toxins in mussels
Sporadic occurrence of paralytic shellfish poisoning (PSP) and diarrhoeic shellfish poisoning (DSP) due to the consumption of mussels containing algal toxins can cause serious problems to public health. In order to protect consumers from potential hazards, monitoring programmes on shellfish toxicity, based on mouse bioassays, have been implemented in Denmark.  LAB Research Denmark has performed the mouse bioassay since 1984 when the surveillance programme was established in Denmark.  LAB Research Denmark also performs the test on mussels and other imported shellfish products from Sweden, Norway, Iceland, Greenland, Faroe Islands and Germany.