Animal Quality

All animal work performed at CTAC complies with all federal/national and state/provincial regulations governing animal care and use in the US and China. We strive to maintain an animal welfare standard that meets and frequently exceeds guidelines set forth by AAALAC and the Office of Laboratory Animal Welfare (OLAW) of the NIH. The principles of our animal care and use include:


1. The Institutional Animal Care and Use Committee (IACUC) of CTAC is properly appointed in accordance with the Animal Welfare Act (AWA) of the US, “Guide for the Care and Use of Laboratory Animals” (“Guide”), and PHS Policy on Humane Care and Use of Laboratory Animals.


2. The mandate of the IACUC includes: 1) review CTAC’s program for humane care and use of laboratory animals at least once every six months, using the “Guide” as a basis for evaluation, 2) physically inspect the animal facility at least once every six month, using the “Guide” as a basis for evaluation, 3) prepare reports of the IACUC evaluations as set forth in the PHS Policy IV.B.3 and submit the reports to the CEO, 4) review concerns involving the care and use of animals, 5) make written recommendations to the CEO regarding the animal program, facility, or personnel training, and 6) review and approve animal care and use protocols (ACUP).


3. All animals receive every reasonable consideration for their comfort and well-being. Please see the “Animal Husbandry” section for details of animal diet, water, housing environment, and regular monitoring.


4. All employees involved with the care and use of animals must complete required training in order to become qualified to work with live animals. The training includes: 1) humane methods of animal maintenance and experimentation, 2) the concept, availability, and use of research methods that limit animal use or minimize animal distress, 3) proper use of anesthetics and analgesics, and 4) mechanisms for reporting deficiencies in animal care and use. Employees involved in animal surgery must receive comprehensive training and pass a stringent qualification process before they are allowed to perform surgical procedures. Written reports of training will be submitted to the IACUC, and kept on file for a minimum of three years.


5. All surgical procedures must be approved by the IACUC. Proper aseptic procedures are used for surgery. The veterinarian is responsible for recommending all anesthetics, analgesics and other drugs used for surgery, which are approved by the IACUC. Appropriate post-surgical care is provided where the animals are observed until full recovery from anesthesia without signs of significant pain or distress.

Overview

Cyagen Transgenic Animal Center (CTAC) is a state-of-the-art, specific-pathogen free (SPF) barrier facility located in China. It houses 6,000-7,000 cages of mice in an ultra-clean environment. The facility’s housing space is divided into multiple separate barrier areas, each with its own restricted access, ventilation system, and husbandry staff.

Accreditations

CTAC facility in China is AAALAC accredited and OLAW assured.

Information Security

All information pertaining to clients’ projects is treated in a strictly confidential manner. Information is stored on company servers in secured areas with daily backups. All systems are password protected, allowing restricted access only to authorized personnel. Information from one client’s project is never shared with other clients or third parties. Upon initiation of a client’s project, project tracking numbers are used during production in place of information that could be used to identify the client. Only authorized personnel such as project managers have access to the original client information.

Animal Husbandry

Housing

Animals are housed in exhaust ventilated cage (EVC) systems or individual ventilated cage (IVC) systems. Each rack can accommodate 70-100 cages depending on the type of rack. Each cage houses 1-5 adult mice. For pre-weaning pups, only the pups and their mother are housed in the same cage. Mice showing signs of fighting are separated into different cages.

Ventilation

Air in the facility is controlled by fully enclosed ventilation systems. Different barrier areas in the facility are ventilated by independent systems. Air is filtered to class 10,000. The rate of ventilation is >15 air changes per hour. Air source is >70% fresh (filtered from outside). Pressure in the animal housing areas is >10 Pa higher than the corridors, and pressure in the corridors is >10 Pa higher than the outside. Pressure gradients are monitored and recorded on a daily basis. Performance of the ventilation systems is certified annually by the Guangdong Laboratory Animals Monitoring Institute. Assessment is also conducted when problems arise (e.g. strong odor, rushing noise when doors are opened, stagnant air, etc.).

Temperature, Humidity and Light/Dark Cycle

Temperature and humidity are controlled by fully automatic air conditioning systems. Temperature is kept at 24±2°C Humidity is kept at 40-70%. Light/dark cycle is automatically set for light from 6 am to 6 pm, and dark for the rest of the day.

Personnel Gowning

Reusable whole-body covers (covering entire body from head to toe except face and hands) and presterilized single-use gloves and surgical masks are worn by personnel accessing the barrier facility. Whole-body covers are washed and autoclaved after each use. Gowning takes place in an area prior to entering into the facility. Air shower is applied at the entrance of some barrier areas.

Diet and Water

Presterilized diet is purchased from reputable vendors manufactured to the standard published by the Chinese government (No. GB 14924.3-2010, Laboratory Animals: Nutrients for Formula Feeds). The quality of diet is monitored via periodic testing by state-approved third-party test providers. Water is filtered from the city’s public water system, placed in bottles with sipper tubes and autoclaved prior to use.

Bedding and Nesting Material

Bedding is purchased from reputable vendors. It is placed in cages and autoclaved with the cages prior to use. Additional enrichment items such as nesting materials and paper cups are provided where appropriate. These materials are autoclaved before use.

Cage Change and Cage Washing

Cages are changed once per week on designated animal change stations with HEPA-filtered laminar air flow. Changes are also done when need arises. Dirty cages are washed with water manually and inspected visually for cleanness. Bedding is then added and the cages are autoclaved, with temperature sensitive labels placed inside of selected cages to monitor the effectiveness of the sterilization.

Animal Monitoring

Animals are observed by animal care personnel on a daily basis. Any animal injuries, illness or death are recorded. Animals showing signs of significant pain or distress will be sacrificed. Animals showing signs of mild to moderate pain or distress will be placed under closer monitoring. If the signs persist, the animals will be sacrificed.

Mouse and rat colonies at Cyagen Transgenic Animal Center (CTAC) are housed in AAALAC-accredited SPF barrier facilities. They are monitored for a range of pathogens using sentinel animals on a quarterly basis, and more frequently when needed. Sentinel animals are maximally exposed to all other animals in the barrier by soiled bedding transfer. Each sentinel cage contains multiple sentinel animals, of which soiled bedding comes from different cages in the colonies. After six weeks, sentinel animals are tested for bacterial, viral and parasitic pathogens. Each sentinel cage typically monitors 50~100 cages. Direct contact method is also used for testing pathogens that are spread through secretion in a small space. In this method, some experimental animals are selected to be housed in the same cage as the sentinel animals for an extended period of time before the sentinel animals are used for pathogen testing. Finally, a subset of the experimental animals are randomly selected for direct testing. Tests are conducted by a number of reputable test providers including Charles River Laboratories (CRL), Vital River Laboratories (which is CRL’s China Branch), IDEXX Laboratories, and Guangdong Experimental Animal Testing Center.

The table below lists excluded pathogens for CTAC’s mouse and rat colonies.

Excluded Pathogens Mouse Rat
Virology Ectromelia virus (ECTV) SEO (Hantavirus) (HV)
Rotavirus (EDIM) Mouse adenovirus 1 & 2 (MAV)
Lymphocytic choriomeningitis (LCM) Sialodacryoadenitis Virus (SDAV)
Minute virus of mice (MVM) Pneumonia virus of mice (PVM)
Mouse parvovirus (MPV) Reovirus type III (Reo-3)
Mouse hepatitis virus (MHV) Sendai virus (SV)
Mouse adenovirus 1 & 2 (MAV) Theiler's-like Virus of Rats (RTV)
Mouse norovirus (MNV) Rat parvovirus (RPV)
Pneumonia virus of mice (PVM) Polyoma virus (POLY)
Reovirus type III (Reo-3) Rat coronavirus (RCV)
Sendai virus (SV)
Theiler's mouse encephalomyelitis virus (TMEV)
Polyoma virus (POLY)
Mouse cytomegalovirus (MCMV)
Hantaan (HANT)
Hantaan (HANT)
Mouse thymic virus (MTV)
K virus
Microbiology Corynebacterium kutscheri Corynebacterium kutscheri
Corynebacterium bovis Clostridium piliforme
Clostridium piliforme Campylobacter genus
CAR bacillus CAR bacillus
Citrobacter rodentium Citrobacter rodentium
Klebsiella oxytoca Klebsiella oxytoca
Klebsiella pneumoniae Mycoplasma pulmonis
Mycoplasma pulmonis Pasteurella pneumotropica-Heyl
Pasteurella pneumotropica-Heyl Pasteurella pneumotropica-Jawetz
Pasteurella pneumotropica-Jawetz Salmonella genus
Salmonella genus Staphylococcus aureus
Staphylococcus aureus Streptococcus pnemoniae
Streptococcus pneumoniae Streptobacillus moniliformis
Streptobacillus moniliformis Beta strep. sp. - Grp A
Beta strep. sp. - Grp A Beta strep. sp. - Grp B
Beta strep. sp. - Grp B Beta strep. sp. - Grp C
Beta strep. sp. - Grp C Beta strep. sp. - Grp G
Beta strep. sp. - Grp G Bordetella bronchiseptica
Bordetella bronchiseptica Helicobacter genus.
Helicobacter genus.
Pasteurella multocida
Parasitology Cryptosporidium Cryptosporidium
Pinworms Pinworm
Furmites Mite
Giardia Giardia
Spironucleus muris Spironucleus muris
Pneumocystis murina Tritrichomonas genus
Tritrichomonas genus Entamoeba
Entamoeba
Encephalitozoon cuniculi (ECUN)