Quality Assurance (QA) & Quality Control (QC)

The Quality Assurance (QA) and Quality Control (QC) of Haimen Animal Center are maintained under the dual supervision of the QC Department and the IACUC. The QC tests performed at Haimen Animal Center include:

  • Monthly: in-house microbial tests from mouse fecal pellets by PCR and culture performed on each rack.
    • Agents Testes: Mouse Hepatitis Virus (MHV), Helicobacter spp., S. aureus, P. aeruginosa, Proteus mirabilis. 
  • Quarterly: Animals in sentinel cages are submitted for microbial tests to SuZhou Xishan Biotechnology Inc. (China center of VRL).
    • Immunocompetent Mice: 45 agents
    • Immunodeficient Mice: 48 agents 

Additional microbial agents can be added to our standard panel per request of our clients. At the end of 2017, a total of 61 agents were tested to meet clients’ requirements and the test results were all negative.

Quality Control of Animal Microbiology

Quality Control of Animal Genotypes for Homozygous Expansion Breeding

Stage 1: 100% Sampling

From F1 to F3 generations, 100% of offspring from the first two litters of each breeding pair per generation are validated by PCR for modified alleles.

Stage 2: 20% Sampling 

20% of F4 offspring (breeders are confirmed homozygotes) from the first two litters of each breeding pair are validated by PCR for modified alleles.

F1 offspring produced by IVF-based rederivation of homozygotes are also sampled at this rate.  

Stage 3: 5% Sampling 

5% of F5 offspring (breeders are confirmed homozygotes) from the first two litters of each breeding pair are validated by PCR for modified alleles.

Stage 4: Quarterly Sampling 

From F6 to F7 generations, 5% of offspring are validated by PCR for modified alleles every quarter.

Stage 5: Annual Sampling 

From F8 generation onwards, for any given population size greater than 1000 in each generation, 16 offspring are randomly sampled and validated by PCR every month. For any given population size below 1000, 5% of offspring are randomly sampled and validated by PCR every quarter.

A comprehensive genotyping by sequencing of all marker alleles for a given strain is performed annually by randomly sampling a small number of animals.

Note:

For every tested mouse, its tail is clipped at the time of weaning (3 weeks old). For mice kept as future breeders, their tails are collected again prior to mating set up (~6 weeks old) for genotype verification.

Note: If genotyping indicates presence of heterozygous offsprings, the sampling complexity at which stage these heterozygous mice are detected will be extended to the next sampling stage. For example, if there are heterozygous offsprings detected of mice in the Stage 1, where 100% of offsprings (F1, 2, or 3) are genotyped, the 100% sampling for genotyping will be extended to F4, where Stage 2, 20% sampling would normally take place.

Personnel Qualifications & Training

  • Over 180 animal care and production personnel certified through a rigorous internal training program work at Haimen Animal Center.
  • More than 50 animal SOPs are strictly implemented.
  • An on-site board certified veterinarian and four veterinarian assistants ensure animal health and welfare. 
  • Director of Animal Production and Director of Animal Center Operations having combined over twenty years of experience in animal husbandry and breeding are in charge of all aspects of Animal Center operations including proactive epidemics prevention, genetic marker tests and stability, environmental conditions in animal production and guarantee high-quality animal studies.

Accreditation

In November 2019, Haimen Animal Center was successfully accredited by AAALAC. 

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