Taconic Biosciences Introduces the AWARE™ Program

Improving Animal Welfare and Resource Efficiency

As a leading provider of genetically engineered rodent models for more than 70 years, Taconic Biosciences is committed to upholding animal welfare best practices for our animals while offering the best scientific solutions to our customers. The AWARE™ (Animal Welfare Aligning with Resource Efficiency) Program demonstrates our dedication to drive greater awareness of animal welfare and to facilitate alignment of research programs with the ‘3Rs’ of animal research: Replace, Refine, and Reduce.

The AWARE™ Program is a Valuable Research Tool

The AWARE™ Program empowers our staff and researchers in the scientific community to proactively plan, execute, and monitor breeding projects maintained at Taconic within Colony Management Solutions. With the implementation of the AWARE™ Program, we ensure projects are designed to fulfill the scientific needs of the research project while maintaining a keen eye on genetic integrity, animal utilization, and the '3Rs'. At Taconic, we are committed to continuing our efforts in developing tools and resources. The launch of the AWARE™ program is a key first step in creating an industry-leading framework guiding the monitoring and reporting of animal welfare observations, animal utilization, adverse phenotypes, and much more.

The Taconic AWARE™ Program consists of two major principal arms that are closely connected, but each serves a distinct purpose.

The Design & Planning arm takes into account best practices, preventive measures, and the 3Rs in every colony at Taconic. This is ingrained in Taconic’s Sales Inventory Operations Planning (SIOP) process that ensures animal model production levels are set based on demand and only produce the animals needed to supply critical-reach animals. All colonies get assigned an AWARE™ Score, which is our way of transparent communication with the community.

In the Monitoring & Reporting arm, we utilize the elements from the design and planning arm to set appropriate performance indicators, monitoring thresholds, and animal utilization metrics. This is done to maximize the use of every dollar spent on research and to reduce the overall number of animals needed.

It is the combination and inter-dependencies between the individual elements within each arm that make up the Taconic AWARE™ Program. Taconic is pleased to put forth a program that reduces animal waste while guiding researchers to more robust study design. We look forward to further developing the program as we embrace our commitment to realizing the 3Rs through industry-leading services.

Taconic’s AWARE™ Program Rating and Explanation Guide

The blue letter “A” symbolizes AWARE™ and contains four colored triangles where each triangle represents a category and is included in your project proposal.

Taconic’s AWARE™ Program Score Card

Animal Utilization
Pain and Distress
Genetic Integrity
Adverse Phenotype

Animal Utilization: The percentage of animals in a project utilized to fulfill cohort goals and/or utilized as breeders relative to the total number of animals produced in the project.

Maximizing Animal Utilization in a breeding program is the most powerful way to increase resource efficiency and to reduce animal wastage.

The “plan as you go” approach to Colony Management, which is characterized by unclear expectations for breeding performance and undefined goals for each breeding task generally results in a waste of resources through either overproduction or underproduction. Lack of oversight and suboptimal breeding plans often lead to overproduction and animal wastage. On the other hand, an intentional reduction of colony size to save costs may lead to underproduction, which can compromise studies, delay timelines, and/or risk the survival of the colony. Taconic can provide breeding design options that maximize animal utilization, thus allowing researchers to align their research programs with the ‘3Rs’. Furthermore, Taconic can provide shipment reports and animal usage reports that give detailed overviews of animal utilization in ongoing colony management projects.

Examples of how to maximize animal utilization are listed below:

Using both sexes for studies
Increasing the age range of mice in cohorts
Changing the breeding format (e.g. from HET x HET to HOM x HOM)
Changing the breeding strategy (e.g. from continuous breeding to peak breeding)
Cryopreserving and closing lines that are not being used

Pain and Distress: The amount or duration of pain and/or distress an animal may experience throughout a breeding project.

Any procedure that would cause pain or distress in a human would be considered to cause pain or distress in other animals. As the welfare of laboratory animals is of the highest ethical and scientific importance, Taconic aims to provide complete transparency of the pain and distress an animal may experience while enrolled in breeding projects. Taconic has implemented robust standard operating procedures to reduce the pain and distress experienced by animals in our care. We find that most breeding projects carried out in our facilities fall within a score of 2 (Momentary) or 3 (Relieved).

Genetic Integrity: The risk of genetic drift over time as well as genetic variability within and across cohorts.

The Genetic Integrity score provides an overview of the risk of genetic drift over time, the risk of genetic drift across parallel mating formats, and the risk of variability due to a mixed genetic background or other factors. Genetic drift is a result of random mutations in the mouse genome that are passed on to the next generation in a breeding colony. Statistically, 10 generations of inbreeding results in 50-200 new single nucleotide variants and 3-12 new insertions/deletions compared with the original strain. Genetic drift cannot be monitored by SNP testing and must therefore be controlled by implementation of strategies for genetic background stabilization. By maintaining a colony in alignment with Taconic’s best practice recommendations we support researchers in controlling the genetic variability within and across cohorts and minimizing the potential for genetic drift. In general, it is recommended to reduce the risk of genetic drift by backcrossing to the inbred background strain when possible.

Examples of optimized colony management that help delay genetic drift are listed below:

Accurate reporting of generation number
Report unexpected phenotypes and follow recommendations for removal of affected animals from breeding colony
Cryopreserve strains at an early generation number
Continuous refreshment of rodent colonies
Genetically refresh a colony when it reaches a generation number of 10 (for example by stock recovery or backcross)

Adverse Phenotype: The severity of an adverse phenotype an animal may experience as a result of the genetic modification(s).

Before a new project is transferred to Taconic’s Colony Management Solutions, the potential of the model developing an adverse phenotype is assessed by Taconic’s IACUC (US) or Oversight Body (EU). The assessment and accompanying AWARE™ score is based on publications and information provided by the customer. If an adverse phenotype is expected, Taconic’s assessment will include disease classification and a description of anticipated symptoms. Moreover, recommendations associated with expected clinical observations, instructions for special care and defined humane endpoints specific for the project will be made available to Taconic’s operations team and any other relevant stakeholder. Projects with AWARE™ scores of 3 to 5 will be closely monitored during project execution.

Burden & Animal Welfare Assessment

Taconic’s Burden & Animal Welfare Assessment package provides researchers with an easy, affordable path to initiating breeding of novel GEMs. We offer the service both as a standalone option and as an integrated part of your colony management project at Taconic. For our standalone option, Taconic will design your project plan, breed and genotype the animals, monitor and report on clinical observations, and conclude the project with a comprehensive report detailing: Any observed adverse phenotypes, pre- and post-wean production data, and a final animal welfare assessment. Once the project is complete you can decide to continue to breed with Taconic or receive the animals and establish a breeding colony in your own facility. Either way, you are well-positioned for the next step on your journey!

What is included in the package?

Fixed Project-Specific Price
Fully Designed Project Plan
Burden & Animal Welfare Assessment Report
Breeding at a Taconic IHMS Health Standard
Seamless Transition to Establishment of Production Breeding

Taconic will keep a record of clinical observations associated with each project, and Animal Burden Reports/Severity Assessment Reports are available upon request.

How Taconic Biosciences can support your research through a focus on animal welfare

Development of optimized breeding plans to align production with demand, thereby reducing animal wastage and cost. Taconic’s Geneticists, Scientific Program Managers and Application Scientists provide expertise, experience and guidance when each project is designed.

Qualified monitoring and experienced management of rodent colonies ensures a continued focus on animal welfare while allowing for breeding strategy adjustments to further optimize animal utilization and genetic integrity

Implementation of strategies to reduce genetic drift mitigates the risk of variability in study results, thereby facilitating reproducibility in research within and across studies and laboratories

Adverse phenotype assessment including recommendations for special care and humane endpoints by Taconic’s experienced veterinarians are readily available to support customer IACUC/OB for in-house protocol set-up pending import of cohorts from Taconic

Skilled management of adverse phenotypes with defined humane endpoints reduces pain and distress to a minimum, which is crucial for maintaining research quality.

Access to a library of supporting documents and reports capturing all relevant information on adverse phenotype, breeding strategy, animal utilization and more collected during the lifetime of each project.

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Taconic Biosciences, Inc. is dedicated to accelerating advancements in human health through in vivo scientific research. This policy supports how Taconic honors and respects the contributions that our models and animal research make to life-saving discoveries.

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