Navigating the Drug Development Pipeline: Expertise for Highly Potent API Product

This technical note explores the sources of error in gravimetric measurements used for aerosol photometer calibration, emphasizing the impact of discrepancies in aerosol properties, temporal instability, and flawed experimental procedures. It supports the two-point calibration practice to minimize errors, particularly at lower concentrations, and recommends measures such as improved aerosol systems and automation to enhance calibration accuracy. The findings aim to ensure reliable photometer performance for critical applications.

This technical note discusses the rationale for using two-point calibration and multi-point verification in the calibration of aerosol photometers. It explains the theoretical basis for the linear relationship between photometric response and aerosol mass concentration, highlights practical challenges with multi-point calibration, and advocates for two-point calibration to minimize errors. The combination of two-point calibration and multi-point verification ensures the accuracy and performance of the photometer in critical applications.

Example of how we offer creative and interesting solutions to our customers to improve efficiency in production.

We want to inform our customers that we have an excellent tech center available to assist them to develop together tailor-made solutions and personalized technologies, solve problems and complete hands-on training on our machines.

Highlighting the importance for our clients to prepurchase multi-year maintenance contracts, in order to avoid their machines breaking or stopping to work suddenly and unexpectedly, to minimize the risk of interrupted production and emergency maintenance costs.

Lipid nanoparticle (LNP) formulation development begins on a small scale, often with homemade or benchtop setups, using syringe pumps and easily accessible micro-mixing systems. Once a promising formulation has been identified, the next step is to transition to standardized large-scale impingement mixing systems, such as the high flow T-mixing pumps that were used to produce the COVID-19 vaccines (Sealy 2021). Formulators need to consider a number of factors when scaling up novel LNP systems. These include flow rates that affect LNP particles, solvent removal, risk factors when changing equipment, and the impact of tangential flow filtration sensitivity. In this technical note, we discuss these factors and what needs to be considered when developing a cost- and time efficient large-scale process.