If your organization is on track to undertake animal studies, it is essential to be prepared for how you will pursue and support the in vivo stage of your preclinical program. In vivo research is a significant step from in vitro research, and requires highly specific facilities, equipment, infrastructure, and regulatory requirements.
There are four core components to consider when planning for animal studies: Control, Facilities, Compliance, and Support.
When conducting studies with rodents, the first thing to consider in planning is how much control you will need over your studies, which will inevitably impact timelines, finances, and confidence in data collection. Outsourcing to a contract research organization (CRO) can be an effective way to reduce the complications of conducting animal research, because they will do it all for you. Outsourcing is often the best option for smaller teams or virtual companies, but this method requires relinquishing direct control of your studies, as well as a level of risk when someone else is executing your science. Additionally, when outsourcing to a CRO, your organization will likely experience significant wait times for your studies to begin and results to be processed.
There are two leading options available to teams which prefer to be hands-on with animal research programs. They can build and operate (internalize) their own vivarium or choose to conduct their studies in a contract vivarium (CV). Internalizing your own vivarium facility enables full control of your studies, and is an option typically chosen by well-funded, high-potential clinical phase companies. However, this process is extremely costly and time consuming to build, equip staff, and manage.
The contract vivarium, which is a turnkey, full-service animal research facility where companies can rent space and conduct their own studies, also offers full control of their research, but without the expense, wait times and headaches of internalizing a vivarium.
The contract vivarium is a rapidly emerging option in the market and is a good choice for next-gen biotechs who would rather keep studies in-house than outsource. Generally, these companies are operating on initial grant, seed, or early series funding. The CV option also removes the complex process of building, staffing, and managing a vivarium as a contract vivarium provides all that for you.
An animal research facility is quite different than in vitro, or wet lab, space because the vivarium environment is supporting live animals. To support necessary biosecurity measures and safety protocols needed for animal research, vivarium facilities are designed with specific HVAC and environmental control systems and are equipped with specialized equipment and power backup systems to ensure a safe, stable, and contaminant-free environment for both animals and researchers.
Mispro vivarium facilities (and most rodent vivaria) support Biosafety Level One (BSL-1) and Biosafety Level Two (BSL-2) studies and contain separate animal holding and procedure rooms. Animal holding rooms are where the animals are housed in individually ventilated, or IVC, rack and caging systems. Holding rooms typically include biosafety cabinets for cage changes and non-invasive animal work. Procedure rooms are where the majority of studies and engagement with animals is done, and typically exist within holding rooms, but separated by an airlock door. Procedure rooms include a biosafety cabinet, workbench, and space for special equipment.
If you choose to build a vivarium or utilize a contract vivarium, the facility and program must be certified as safe and compliant for laboratory animal research. This requires that the facility and laboratory animal program is AAALAC accredited. The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) is an international nonprofit that sets the gold standard for humane care in the use of research animals.
Compliance with state and local regulatory oversight and licensure is required to conduct animal studies. It can be an arduous and sometimes confusing process to manage, but adherence to compliance measures combined with quality oversight of your program can significantly contribute to the success of your animal studies. Traversing these regulations can be quite a challenge for small startups. Working with experienced compliance professionals can help. Most CROs and contract vivarium organizations (CVO’s) will have an in-house compliance team to help clients adhere to any federal, state, or local ordinances. For those companies that are considering internalizing a vivarium, you can build your own team or connect with external compliance consulting services. You can also insource your compliance.
Compliance programs are centered on the Institutional Animal Care and Use Committee (IACUC). Most animal studies will need to be approved by the IACUC, which reviews your study protocols to ensure adherence to local, state, and federal regulations for the ethical and humane use of animals in research. The IACUC can often be seen as just another administrative hurdle for conducting animal studies. However, when done well, the guidance by a well-rounded and experienced IACUC can be a significant asset to your research and contribute to the overall success of your studies.
Animal Husbandry is required for animal research and includes daily care to ensure animals are stable, healthy, and well maintained in a clean environment. Veterinary oversight regularly monitors the health of the animals and vets are on call to diagnose and prescribe for when animals are sick. Clinical vets also ensure that animal study protocols are being followed.
The humane care of laboratory animals is essential, both ethically and scientifically. Stable animals who are healthy and free from stress significantly increase the likelihood of reproducible data collection in your studies, which is an important hallmark of the scientific method.
To conduct research with animals, basic animal handling skills may be needed, as well as experience with tissue collection, working with syringes, surgical procedures, and even breeding colony maintenance, depending on your study design. For midsize biotechs or biopharma’s looking to internalize a vivarium, you likely have qualified researchers already on your team. But for earlier stage companies, outsourcing your studies to a CRO or leveraging services offered by a contract vivarium are readily available options.
Mispro, and most CV’s, offer in vivo technical services support where skilled veterinary technicians can perform a single task or conduct an entire study for you. Tech Services can also provide training for your team in a variety of areas.
When procuring research animals, it is important to choose a reputable and qualified vendor for obtaining your models. You may need specific animal models for your studies such as transgenic animals to model specific diseases, or animals with implants or catheters. Most rodent vendors such as Charles River, Jackson (JAX), or Envigo will do their own due diligence to ensure the proper veterinary and/or regulatory oversight is in place for your studies before they will provide you with animals.
For companies who use a vivarium or are considering building a vivarium, insourcing is a solution that enables you to focus your team and resources on research, while the insourcing service handles everything from animal husbandry, to veterinary oversight, to compliance and technical services. Most contract vivarium providers offer insourcing, but insourcing is also available by insource-only providers. However, these providers may not offer all of the services provided by a CV.
As you determine the most suitable methodology for your organization to launch your animal studies, explore how Mispro can help support the in vivo stage of your preclinical program.