Production Systems

Articles should focus on the full range and scope of unit operations and production steps for manufacturing APIs, both small molecule and biologic pharmaceuticals, the building and critical process utility systems that support the manufacturing process, as well as the means of managing, dynamically controlling, and automating manufacturing and warehousing operations. Articles could highlight production unit operations, management, and control.

Using CFD Multiphase Modeling to Predict Bioreactor Performance
Technical
Using CFD Multiphase Modeling to Predict Bioreactor Performance
Computational fluid dynamics (CFD) can reduce or eliminate the need to perform bioreactor scale-up studies because full-scale manufacturing bioreactors can be simulated to predict performance. This article discusses the use of computational fluid dynamics for that purpose, to predict the...
Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Technical
Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and...
A Gamp® Approach to Robotic Process Automation
Features
A GAMP® Approach to Robotic Process Automation
This article introduces the concept of robotic process automation (RPA) and discusses how the technology may be used within a GAMP® framework to support both non-GxP and GxP processes.
Article
Technical
Purification Of Synthetic Peptides
High-pressure liquid chromatography employing the multicolumn countercurrent solvent gradient purification (MCSGP) process principle has been developed as a novel purification technology for peptides produced by chemical synthesis. MCSGP offers a step change in efficiency compared to batch...
Using CFD Multiphase Modeling to Predict Bioreactor Performance
Technical
Using CFD Multiphase Modeling to Predict Bioreactor Performance
Computational fluid dynamics (CFD) can reduce or eliminate the need to perform bioreactor scale-up studies because full-scale manufacturing bioreactors can be simulated to predict performance. This article discusses the use of computational fluid dynamics for that purpose, to predict the...
Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Technical
Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and...
A Gamp® Approach to Robotic Process Automation
Features
A GAMP® Approach to Robotic Process Automation
This article introduces the concept of robotic process automation (RPA) and discusses how the technology may be used within a GAMP® framework to support both non-GxP and GxP processes.
Article
Technical
Purification Of Synthetic Peptides
High-pressure liquid chromatography employing the multicolumn countercurrent solvent gradient purification (MCSGP) process principle has been developed as a novel purification technology for peptides produced by chemical synthesis. MCSGP offers a step change in efficiency compared to batch...
Article
Technical
Evaluating In-line Volume Reduction During mAb Production
In-line concentration solves problems found in mAb production, including insufficient storage capacity and process tank volumes, extended processing times, and large hold-up loop volumes for ultrafiltration concentration. It optimizes the ion-exchange step following capture, reduces costs and...
Article
Technical
Statistical Approach for CU Testing CPV Batches & Comparison with USP <905> UDU
The USP &lt;905&gt; UDU test, widely used for batch release since 2007, is no longer supported by FDA. We propose a two-sided tolerance interval method to alleviate this deficiency. The approach provides 50% confidence and 95% probability that future samples from the batch will conform to USP...