Design of a reliable process for bacterial antigen production requires understanding of and
control over critical process parameters. Current methods for process design use extensive …

Batch-level inference-based quality control is the standard practice for drug products.
However, rare drug product defects may be missed by batch-level statistical sampling …

This case study provides an example of how Quality by Design (QbD) principles were
applied to accelerate process development to manufacture a vaccine candidate at …

The restimulation of an immune memory response by in vitro culture of blood cells with a
specific antigen has been used as a way to gauge immunity to vaccines for decades. In this …

The aim of this paper is to describe a methodology for developing a per product qualitative
and semi-quantitative business case for application of quality-by-design (QbD) for a …

Quality by design (QbD) is frequently implemented during product development nowadays. It
allows to optimize the production process in a way such that the obtained product has the …

Mycoplasma hyopneumoniae (M. hyopneumoniae) is a bacterial pathogen that has evolved
from a gram-positive ancestor and specifically colonizes the lower respiratory tract of pigs …

Das Life-Cycle-Management (LCM) ist in vielen industriellen Bereichen schon lange ein
gängiges Verfahren zur Planung, Überwachung und Optimierung der Herstellung und des …