Agenda

Microparticles / Andreas Krekeler

Liposomes / Klemen Naveršnik

GP2017 differences in immunogenicity / Lena Lemke

(R)evolution of technical development of biosimilars / Matjaz Brinc + Matjaz Boncina

Structure-function models, key support for informed biosimilar development / Barbara Podobnik + Chien-Wen

AMIGO - Machine Learning for HPLC / electrophoresis methods / Franz Innerbichler, Nika Valencic

Modelling techniques for biopharmaceuticals (molecular modeling, mixing) / Omar Naneh

Considerations, Learnings and Case Studies on Freeze Thaw associated stress on Biologics Drug Substance / Georg Hölzl, Christoph Bitter, Karoline Bechtold-Peters

Skyrocketing Product Development with IDEAL PD Assistant / Ognen Jakasonovski

COAST - the first digital SSM clinical tool / Andrea Vetter

Luminata - Paving the way for Machine Learning in drug development / Udo Pauritsch

Unique High throughput multivariate method for evaluation of of oncology products / Sumanth K Prabhu

Celecoxibe journey to China - from technological transfer to succesful biostudy / Rižner Leon, Skubin Simon

An unexpected root cause of nitrosamines in drug products / Rok Grahek, Kocijan Andrej, Nejc Golob

Statistically significant versus practically relevant trend in stability data / Bernhard Schmelzer

Early identification of factors to control in vivo variability in bioequivalence of orally inhaled products - Ellipta deformulation study / Arindam Pal

Product understanding strategy to realize Gx to Ellipta^® platform  / Biswadip Sinha