news
Vaccine slows loss of insulin production in type 1 diabetes genetic subgroup
In a Phase II trial, injecting GAD-alum into the lymph nodes of newly diagnosed type 1 diabetes patients with a genetic variant slowed insulin production degradation.
List view / Grid view
Linköping University
news
Artificial retina may restore sight
A simple retinal prosthesis is being developed in hope that it can restore sight to blind people...
article
PAT and design science
23 May 2007 | By Carl-Fredrik Mandenius, Micael Derelöv, Jonas Detterfelt, Mats Björkman, Division of Biotechnology/IFM and Division of Production Systems/IKP, Linköping University, Sweden
Process analytical technology (PAT) and mechanical design science are interconnected; this article describes how a well-established design modelling approach; the Hubka-Eder model, is applied to the concepts of PAT and quality by design (QBD). The model connects PAT with quality management concepts as defined for PAT by the ICH guidelines…
article
The role of PAT in biotechnology
23 May 2006 | By Carl-Fredrik Mandenius, Linköping University, Sweden, Member of the European Federation for Pharmaceutical Sciences PAT Steering Group
Product quality of pharmaceuticals manufactured in biotechnology processes is to a large extent synonymous with the reduction and control of unwanted biological side-products. Production of biopharmaceutical proteins and secondary metabolites such as antibiotics are the result of biosynthetic capacity of the microbes or cells used. But this capacity may also…
