Frequently Asked Questions
HOW WE OPERATE
What we do
We evaluate the pharmacodynamic efficacy potential of investigational compounds targeting brain diseases using translational EEG Biomarkers in vivo in freely-moving animal models.
SynapCell is a CNS-expert biotechnology company with more than 15 years of experience in the field of Central Nervous System disorders. As a true partner of the biopharmaceutical industry, we identify and qualify the therapeutic potential of our clients’ lead candidates in Epileptic disorders, Parkinson’s disease, Psychiatric or Neurodegenerative disorders. In other words, SynapCell tests for you the efficacy of your compound.
At SynapCell, we do care about environmental footprint. Our permises are located inside a new energy-efficient building at the heart of the French Silicon Valley, close to Grenoble.
All tests are performed using EEG in vivo, in freely-moving and clinically-relevant rodent models of brain diseases.
Our EEG Biomarker approach enables to objectively appreciate the pharmacodynamic efficacy potential of compounds tested using resting state EEG, Event related (ERP, ASSR) or pharmaco-induced EEG Biomarkers.
Our EEG-based Cue® platform is the smart combination of a team of skilled neuroscientists, clinically-relevant rodent models, high-end recording techniques and proprietary signal processing.
Our pharmacodynamic assays use the robustness and translational power of EEG for:
- Lead selection (screening of small libraries of compounds)
- Lead validation (dose-response effect, pharmacodynamic effectkinetics)
- Disease modifying or neuroprotective potential
- Anti-epileptogenic, anti-epileptic effect using non-convulsive animal models.
- Model phenotyping,
- EEG Biomarker development and identification,
- Program De-risking (pro-epileptic, seizure aggravting effect)
- Dose optimizing, dose ranging.
- Acute or chronic protocols
- Clinical-like, crossover designs
- Exploratory EEG program, designed as a place were you can shape your experiment from A to Z.
We are a fully integrated company, with our own animal and research facilities. As a French organization, the animal facility is certified by the French Ministry of Research and the Veterinarian Service. As of 2017, the facility covers as much as 4310 square feet, and has a capacity of over 400 animals. Access to the platform is restricted to authorized personal exclusively with high-level of security. See Quality &Animal Welfare section for more details.
We do apply the Three R’s sustainability rule (Replacement, Reduction, Refinement) in the way we conduct our activities. In addition, all protocols are submitted to and approved by the Ethic Committee. To support both internal and external R&D programs for our clients, we have developed three cutting-edge platforms in-house for Neurosurgery, EEG/ERP recording and advanced Signal analysis. Everything is therefore performed internally for optimum project efficiency, tracking, quality management and cost optimization.
Keeping close contact with the Sponsor is key for both parties to get aligned on all milestones and deliverables of the study. This is done for each client from project initiation to completion, at every individual step. Your main contacts will be with our Business Development team for commercial and legal steps, our Head of Science for protocol and study design and with the Head of Operations for project coordination and study report.
*for a 12 compounds epilepsy screening on n=4 MTLE mice
02 Project Management
Once commercial and legal steps are completed, and agreement has been made between SynapCell and the Sponsor on the study details, the project is ready for launch. Depending on the nature of the study, this step can take 2 to 3 weeks on average if a planning slot is available.
On average, between 3 to 6 weeks from study launch for first data and from 11 to 15 weeks for the final report if Sponsor compound is received on schedule. For example, a full dose-response assessment of an anti-epileptic compound on the SynapCell MTLE mouse takes 7 weeks to generate the model (Epileptogenesis phase) and 4 to 5 additional weeks to generate the results.
We are committed to providing the Sponsor with proactive feedback all along the study course. The Head of Operations maintains continuous contact with the Sponsor to organize logistics related to compound shipment for example or any necessary information for successful project management. At each important milestone of a study, a meeting with the Sponsor is arranged, to provide an update on the most recent results.
We do not conduct Toxicity nor Safety Studies litterally speaking. We are focusing our offer on preclinical efficacy studies that are performed exclusively in vivo on freely-moving animal models. However, the GAERS model can be used as a derisking model to identify seizure-aggravationg or pro-epileptic effect of any compound. SWD therefore could be used as a safety biomarker. In addition,, we pay a particular attention to animal welfare all along the study course. In the event of potential toxic effect observed, we immediately warn the Sponsor for action.
03 Quality assurance & Animal welfare
The process involved in managing studies start with a study proposal followed by a study design. All animal procedures are carried out in accordance to the guidelines of the European Community’s Council Directive 2010/63/EU on animal protection and welfare. Moreover, all processes, including animal welfare and experimental procedures, are documented in our Quality Management System.
All the staff members involved in the study hold the authorization to perform animal experimentation and have several years of experience in neurosciences, pharmacology, surgery, signal recording or processing. Half of our team holds a PhD, and all SynapCell experimenters are involved in a continuous training program certified by the French Ministry of Agriculture. Training programs could be either internal or external.
All of our lab activities are carried out according to a set of Standard Operating Procedures (SOP) that are documented in our Quality Management System and made available to our customers on request. Efficacy testing does not require GLP compliance; however, our procedures do align with the OECD principles of Good Laboratory Practice [C(97)186/Final], ensuring rigorous Quality Assurance within the lab.
As you know, our experiments, exclusively in vivo, are carried out on translational models. All procedures comply with EU guidelines for the welfare and use of animals in research and are approved by an independent ethics committee, making project starts much simpler.
All studies are performed following SynapCell local Standard Operating Procedures (SOP) and are inspired from the OCDE rule of Good Laboratory Practices [C(97)186/Final]. Even if preclinical efficacy studies are not required to be GLP compliant, SynapCell is aligned with the OCDE principles of GLP and applies its rules.
We are committed to protecting the confidentiality of your studies. Your studies are carried out by our people in a secure environment designed to safeguard your project data and other information.
We have implemented strict access control policies to protect our facilities, computer systems and files, and sensitive data.
SynapCell IT security consists in protecting the company’s computer systems from the theft or damage to its hardware, software or information, as well as from disruption or misdirection of the services provided.
Security measures taken include controlling physical access to the hardware, as well as protecting against harm that may come via network access, data and code injection.
Therefore, Sponsor information is managed by 3 levels of security:
- Physical security: there is a restricted access to the building for everyone, it needs a magnetic badge detained by SynapCell employee
- Daily Backup: workstations are backed up to server once a day and additional backup run every night through Internet on a dedicated remote server
- Access-Information: Incident or failure will be automatically fixed through a SPARE drive automatic take over system.
In addition, all team members involved with the Sponsor’s project are committed to full confidentiality.
To find out more on our capabilities and how we can collaborate, please contact us