Tepnel recognises that the endpoint data from the genotyping pipeline can be applied in a number of different applications from academic research through to support of a marketing authorisation for pharmaceutical development. To facilitate regulatory expectations we can design and tailor a service package which works under the principles of Good Laboratory Practice (GLP) as defined by global regulatory authorities.
Through appointment of a Study Director or Principal Investigator the regulatory conduct of your study is assured from protocol and experimental design through to report production and data archiving. Our independent quality assurance department provide both study specific and process audits as routine whilst additional quality control checks and measures are adopted to ensure the accuracy, validity and reproducibility of the data from start to finish.
A Consultative Process
We can offer a consultative service to establish the scope of your project and how best we might support it, culminating in an agreed study protocol. An assay development service is available and when required, our recommendations for assay validation are discussed and documented with each client prior to embarking on a project. When genotyping data is generated we provide the report to you in the agreed format and understand that this may vary from project to project.
Assured Service
Tepnel is an experienced provider of services to the Pharmaceutical sector including DNA extraction, bio analysis, CMC and microbiology services. We dedicate a project manager to each study who will discuss your requirements and keep you informed throughout assay development and the genotyping process.
Quality
The pipeline has been designed to offer a full audit trail. Modular automation is controlled by GAMP and CFR21 compliant software interacting with a comprehensive laboratory information management system (LIMS). With experienced staff operating to GLP standards, our laboratories are purpose built to support our pharmaceutical service activities.
Value
Efficient, quality controlled processes ensure value is offered to our clients. A novel single-plex assay developed by Tepnel is available as an alternative to the Taqman assay range, with this in-house assay bringing further value to our service offering whether through assay development or genotyping
Convenience, Flexibility and Speed
We provide a simple and convenient way to convey the information about your samples through the use of “easy to use” forms. Our experienced technical staff are always happy to consult and advise but these forms allow you to get your projects to us and underway with little interaction if time is of the essence. Our process can accommodate both large and small projects. In addition, our highly automated processes and dedicated service staff provide turn around times to meet your deadlines and budget.
LIMS, Sample Identification & Registration
Tepnel has a Laboratory Information Management System (LIMS) designed to ensure full traceability of samples and eliminate manual transcriptions. All samples received are registered into the LIMS system and assigned barcodes, a process that requires corroboration by an additional operator thus preventing incorrect assignment and potential loss of sample identity. The LIMS system facilitates control over the movement and traceability of samples throughout processing.
