Process development Strategy for Upstream and Downstream process optimisation. Process Flow diagram; Bottleneck identification; Medium and chromato optimisation; Continuous or Batch process rationale; Wave bag implementation; Cell separation approaches; Buffer consumption; Cleaning issues; Pre-formulation at bulk level; Fill and Finish anticipation; Freeze-drying elimination; Quality attributes.
Internal production or Outsourcing; Final Dosage anticipation; Associated devices; Quality progress as a function of clinical trial. Dimensioning Sizing of manufacturing equipment, Water for Injection production, Steam production.
A Comprehensive Guide to Toxicology in Preclinical Drug Development - Google книги
Process validation PQ philosophy; protocol review; Cleaning validation. Manufacturing Technology Transfer Assistance Protocol and acceptance criteria review; Equipment suitability; Batch record review; Report review. Technology licensing assistance Value analysis; Intellectual property assessment; Negotiation. Continuous improvement implementation Target definition; Performance assessment; Project definition and follow-up.
Analytical assays : development and validation Triskel's experts can define analytical assays, review protocols, data and validation reports for assays required for:. Non-Clinical Our areas of expertise in pre-clinical development include:. Strategic advice and elaboration of efficient non-clinical development plans. The product class, proposed indication, mode of action and species-specificity can greatly affect the extent of the required development programme. As there is no pre-defined non-clinical programme for biological molecules, Triskel can assist with the preparation of abridged development plans when there are no relevant species available for a given product.
Study follow-up from protocol to report.
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Triskel's staff has the ability to design various study protocols for pharmacodynamic, pharmacokinetic, safety pharmacology and toxicology studies. We can perform day-to-day follow-up of the study and data analysis, and to ensure that high quality, regulatory compliant reports are issued. He has published over technical and scientific papers and authored and co-authored 7 book chapters.