Quality by Design and continuous development

LaminarPace: Continuous technological development

Today, Ziccum’s technology development team work continuously on optimizing the system for industrial integration – implementing valuable lessons from its parallel role in external projects. The team is headed up by Ziccum Project Director Stefan Qvarnström, a Technical and Project Manager with over 30 years’ experience in pharmaceutical manufacturing and project management. LaminarPace is currently in its fourth generation of development.

Quality by Design

Ziccum’s development work is underpinned by a rigorous Quality by Design (QbD) approach. QbD is a systematic risk-based methodology, recognized and encouraged in pharmaceutical manufacture by the FDA, that identifies potential risks and variables in all aspects of product manufacture and development.
Current priority features in LaminarPace’s development all contribute towards optimizing the system’s production capacity, reproducibility, reliability, cleanability and sterilization.

Continuous development towards industrial integration

New nitrogen use

Replacing air with nitrogen in the system’s inner drying column has further reduced humidity. Optimization tests demonstrate that following drying less than 2% of absolute humidity is left inside LaminarPace’s drying column.

New powder collector

The installation of a sealed powder collector increases sterility and safety. Ultimately Ziccum aims to develop LaminarPace as a one-stage, aseptic unit of production. Biosafety features such as the powder collector and new cleaning and sterilizing processes are important steps towards achieving this.

New specialist nebulizer

Ziccum has worked with specialist industrial nebulizer manufacturers Tekceleo on optimizing LaminarPace’s nebulizer specifically for delicate biomolecules. In October 2022 the company announced that it had nebulized fragile vaccine lipid nanoparticles (LNPs) using this optimized nebulizer. To Ziccum’s knowledge this is the first time LNPs have been successfully nebulized.

Advanced sensor arrays

Inside LaminarPace advanced sensors map and monitor the flow of the drying procedure, generation voluminous data on this unique drying methodology. LaminarPace’s advanced sensor array is an important enabler of its 3D digital modeling capabilities.

3D digital modelling

The launch of an advanced 3G digital modelling project is a major step towards the industrial integration of LaminarPace. for optimization of flow and scale of production according to substance and volume. The work is being carried out by Ziccum in partnership with the with the ICP Institute of Computational Physics team at the Zurich University of Applied Sciences’s School of Engineering (ZHAW.)