Moredon Scientific Ltd

In vivo assays

In vivo assays screen for agents not known to cause any cytopathic effects in cell culture and are required at various stages of biopharmaceutical manufacturing as defined by international regulatory guidelines.

Moredun Scientific offers a comprehensive portfolio of in vivo biosafety testing services. Studies are conducted in our state of the art GLP accredited animal accommodation.

  • In vivo adventitious agent assays for the detection of viral contaminants. The test article is inoculated into a range of animal species which increases the probability of virus detection. A combination of embryonated eggs, adult mice and suckling mice are generally used with guinea pigs, rabbits and other species included if appropriate. Animals are observed over a 28 day period for signs of ill health. These assays detect the presence of viral contaminants but do not identify the nature of the contaminant. Any positive results would require further investigation.
  • Mouse, Hamster and Rat Antibody Production Tests for the detection and identification of adventitious rodent viruses. Essential assays for rodent cell derived products. Virus antibody-free rodents are inoculated by multiple routes with the test sample and observed over a 28 day period. Serum samples are analysed (mainly by the ELISA technique) for the detection of antibodies to a panel of viruses.(Table 1). A positive test indicates that the test sample has been exposed to the virus.
  • General Safety Test for abnormal toxicity. A survival study, the test article is inoculated into guinea pigs and mice which are observed for 7 days for clinical signs of illness.  A pharmacopoeial requirement for vaccine development.
  • Tumorigenicity studies. The test article is typically injected into nude mice, or other immunosuppressed rodents, which are monitored for signs of tumour formation. Tumorigenicity studies may be required for human epithelial cell lines, human cell lines used for live virus vaccine production and cells used in somatic cell or gene therapy.
  • Custom studies. Please contact us to discuss your specific requirements

 

Regulatory guidelines

The following guidelines refer to the requirement for in-vivo assays in biopharmaceutical manufacturing:

 

Table 1: Viruses detected in rodent antibody production tests

Virus
Abbreviation
Mouse
Antibody Production
Test
Hamster Antibody Production
Test
Rat
Antibody Production
Test
Ectromelia
ECTRO
X
 
 
Epizootic diarrhea of infant mice
EDIM
X
 
 
Hantaan Virus
HANT
X
 
X
Kilham`s rat virus
KRV
 
 
X
Lactate dehydrogenase virus *
LDV
X
 
 
Lymphocytic Choriomeningitis Virus**
LCM
X
X
X
Minute virus of mice
MVM
X
 
 
Mouse adenovirus
MAV 1&2
X
 
X
Mouse cytomegalovirus
MCMV
X
 
 
Mouse hepatitis virus
MHV
X
 
 
Mouse pneumonitis virus
K
X
 
 
Murine encephalomyelitis virus
Theilers,GDVII
X
 
X
Mouse thymic virus
MTLV
X
 
 
Pneumonia virus of mice
PVM
X
X
X
Polyoma virus
POLY
X
 
 
Reovirus type 3
REO
X
X
X
Sendai virus
SEND
X
X
X
Sialodacryoadenitis virus
SDAV
 
 
X
Simian virus 5
SV-5
 
X
 
Toolan`s H-1 virus
H-1
 
 
X

* The presence or absence of LDV within a test sample is confirmed by measurement of serum levels of lactate dehydrogenase.

**The LCM antibody production assay can be supplemented with an intracranial challenge to test for the presence or absence of non-lethal strains of LCM virus.