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

The Cyagen Transgenic Animal Center (CTAC) is a specific pathogen-free (SPF) barrier facility located in China that houses 150,000 cages of mice. The facility's housing space is divided into separate barrier areas, each with independent restricted access, ventilation systems, and animal care staff.

Accreditations

CTAC has been accredited and certified by various organizations on different aspects, including ISO 9001 and AAALAC Full Accreditation. All these accreditation ensure that our services and products meet internationally recognized quality standards.

Regulatory Inspections

CTAC follows the "Regulations on the Administration of Laboratory Animals" promulgated by the State Council of the People's Republic of China and is inspected by the Chinese government every two years. The AAALAC inspection is performed every three years in order to maintain accredited status.

Facility Security

CTAC is located in a fenced-off business park with 24/7 security personnel. The facility is fully monitored by multiple CCTV cameras and security/maintenance personnel are on duty at all times. A backup power generator is available in the unlikely event of a blackout. Only CTAC trained personnel or visitors accompanied by CTAC trained personnel may enter the SPF facility and visitors must sign-in upon entering.

Information Security

Cyagen is committed to the delivery of a first-class confidential service. Information pertaining to clients’ projects is treated in a strictly confidential manner. All information is stored on company servers in secured areas with daily backups. All systems are password protected with access restricted to authorized personnel only. Project information from clients is never shared with other clients or third parties. After a project is initiated, the project tracking number is used in place of information that can be used to identify the client during the production process. Only authorized personnel such as project managers have access to original customer information.

Animal Husbandry

Housing

Animals are housed in 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, the pups and female mice 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 and is filtered to class 10,000. Different barrier areas in the facility are ventilated by independent systems. The air change rate is not less than 15 times per hour. Air source is 100% fresh (filtered from outside). Pressure in the clean corridor is >10 Pa higher than the animal housing areas, >10 Pa higher than the dirty corridors, and >10 Pa higher than the outside. Pressure gradients are monitored and recorded on a daily basis. Performance of the ventilation systems is certified by certificated Laboratory Animals Monitoring Institutions. Assessment is also conducted when problems arise (e.g. strong odor, rushing noise when doors are opened, stagnant air, etc.).

Temperature, Relative Humidity (RH) and Light-dark cycles (LD)

Temperature and relative humidity are individually controlled by a fully automatic air conditioning system. The temperature is maintained at 20-26°C. Relative humidity (RH) in animal rooms is maintained 40-70%. The Light-dark cycles (LD) is 12: 12, with the lights on from 6 am to 6 pm and dark for the rest of the time.

Personnel Gowning

Personnel allowed to enter the barrier facility wear a reusable full-body washable cover suit (covers the entire body from head to toe, except for the face and hands), sterilized disposable gloves, and surgical face masks. Full-body cover suits are washed and autoclaved after each use. Air showers are installed at entrances of some barrier areas. Prior to entering the air shower, workers put on appropriate cleanroom clothing in a gowning room.

Diet and Water

Pre-sterilized diets are purchased from certified suppliers that meet Chinese government standards (GB 14924.3-2010, "Experimental Animals: Nutrients in Formulated Feeds"). Diet quality is regularly monitored by state-approved third-party testing laboratories. Water is filtered from the city's public water system, put into bottles with straws, and autoclaved before use.

Bedding and Nesting Material

Bedding is purchased from a certified supplier, placed in cages, and they are autoclaved together before use. Additional enrichment items, such as nesting materials and shelter, are autoclaved before use.

Cage Change and Cage Washing

Cages are changed weekly at designated animal changing stations. In a typical animal changing station, laminar flow hood (LFH) receives high-efficiency particulate absorption (HEPA)-filtered air which, when supplied under positive pressure, protects animals in cages from airborne infections or other harmful particulate matter present in the environment. Dirty cages are automatically cleaned with cage washing machines and visually checked for cleanliness and visually inspected for cleanliness. Bedding is then added and the cages are autoclaved, with temperature sensitive labels placed inside selected cages to monitor the effectiveness of the sterilization.

Animal Monitoring

Animal care personnel observe animals to assess their health on a daily basis and document any signs of animal injury, illness, or death. Animals showing significant signs of pain or distress will be euthanized. Animals showing signs of mild to moderate pain or distress will be closely monitored and if these signs persist irreversibly, animals will be euthanized.

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)