Toxicology | Pathology | Bioanalytical |Genetic Toxicology

General Toxicology

The Sequani facility has a long tradition of supporting clients with excellence in the management of general toxicology studies in rodent and non-rodent species, all accompanied by on-time reporting. A highly experienced team of study directors work closely with our clients to ensure that studies are conducted to meet both product development and international regulatory needs.

Sequani study directors are highly responsive and are actively involved with their studies from inception through to report finalisation. They work closely with the on-site laboratory animal services, dispensary, analytical chemistry, clinical pathology, necropsy, histology, pathology, QA and information technology staff to ensure that Sequani clients are provided with high quality studies and reports, whatever the study type.

We have a reputation for meeting or beating reporting dates, even against the most difficult target times. Staff always provide good practical scientific input into the study design and reporting but also have the ability to contribute a more specialised scientific content where required

Study Types

• Single Dose Toxicology

• Repeat Dose Toxicology

• Carcinogenicity

Therapeutic Areas

LifeShirt®

The new way to obtain early in vivo cardiopulmonary information on your compound.

The LifeShirt® is a proven technology that wirelessly delivers real-time, non-invasive, life-sign monitoring, by continuous collection, recording and analysis of a broad range of cardiopulmonary parameters. High quality physiologic data can be viewed from unstressed, unrestrained, and uninstrumented animals and analysis can be performed off-line.

Functions of LifeShirt

• Unrestrained, non-invasive data collection
• Continuous wireless transmission of data
• Cardiac and pulmonary studies can be conducted concurrently
• Postural analysis also available

Benefits of LifeShirt

• Improvements in animal welfare and minimisation of stress
• No requirement for surgical implantation
• Simple to use on early stage DRF studies
• Accurate assessment of cardiac and respiratory parameters
• Data can be viewed and analysed in real-time
• Different analytical time points can be selected
• Reduction in the number of discrete experiments and therefore in the number of animals required

• Important for many drug types, particularly CNS active

Juvenile Toxicology

We believe that designing the most appropriate preclinical and clinical programme to support a claim for clinical paediatric use is best achieved in discussion with the customer.

First, and working with the customer, we would undertake a full review of the pivotal studies in the existing preclinical package in order to determine the extent of any further studies that may prove necessary. Such a review would also identify the species to be used for the  preclinical work as well as the most appropriate dosing regime, bearing in mind the therapeutic area and the target paediatric population.

In instances where the compound is currently in development it might prove possible to adapt the design of some of the preclinical studies; for example, adding a juvenile toxicity assessment to the pre- and post-natal development range finding or main study. This could prove a cost effective way to obtain early information on which to base the programme design.

When designing the studies to be undertaken, it is important that the correct endpoints are identified. Studies need to be designed to determine any compound effects, on the overall growth of target organ systems that develop post-natally – and if appropriate, the reversibility of any changes. Working closely with customers, we are able to design studies that we consider will meet the regulatory guidelines while also adequately assessing product safety and tolerability prior to paediatric clinical trials. Study designs should be discussed with the regulators before their implementation to avoid any unnecessary work or delay to the development programme. This approach is encouraged by the regulators who acknowledge that each product in this area needs to be assessed individually.

Reproduction Toxicology

Reproduction toxicology has been conducted at the Ledbury site for over 25 years

The experienced team of Study Directors and consultants, supported by a dedicated foetal pathology group and specialised animal and necropsy technicians make Sequani the laboratory of choice for many pharmaceutical companies.

Dedicated Resources

• a multidisciplinary toxicologist team structure enables reproduction studies to be managed by a product focussed team, including reproduction toxicology specialists, handling the entire preclincal package

• highly experienced staff; several with more than 15 years experience in the field and several with over 25 years

• barriered animal units with facilities designed to accommodate both rodents and rabbits

• highly trained animal technicians with experience in the conduct of the full range of specific reproduction toxicology techniques including:

  • neonatal administration

  • developmental assessments

  • and behavioural observations

• CASA - Computer Assisted Sperm Assessment

• dedicated foetal pathology staff experienced in all aspects of foetal evaluation including both single and double skeletal staining techniques for rats, rabbits and mice

• on-line data capture for both the in-life and foetal pathology phases of reproduction studies

• fast-track reporting available to complement our customers´ clinical programmes

• report times consistently met