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.

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Producing pharmaceutical waters requires carefully designed and continuously monitored processes and equipment. Real-time control and accurate measurement are paramount to ensuring process efficiency and water compliance.
Sponsored Content
Resins, Monoliths, or Membranes? Discover How to Make an Educated Choice.
Sponsored Content
Producing pharmaceutical waters requires carefully designed and continuously monitored processes and equipment. Real-time control and accurate measurement are paramount to ensuring process efficiency and water compliance.
Sponsored Content
Resins, Monoliths, or Membranes? Discover How to Make an Educated Choice.
Technical
Any systematic pharmaceutical engineering approach for ensuring vial container closure system (CCS) performance must include choosing qualified container closure system components, the proper pharmaceutical process setup, and applicable testing methods. Container closure integrity (CCI) is an essential part of container closure system performance. A holistic strategy is needed to qualify...
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Robotic process automation (RPA) software automatically handles manual, repetitive, time-consuming, and highly structured tasks such as data entry and back-office functions. Certain processes specific to the pharmaceutical industry represent strong candidates for RPA implementation, with significant potential savings and the possibility of ensuring compliance.
Technical
Executives at manufacturing companies of all sizes need to make decisions about where to invest to maintain and grow their businesses. Investments in manufacturing execution system (MES) applications may reduce costs and increase revenues, but they also might compete with other investment priorities, such as marketing campaigns and capital equipment upgrades. This article offers guidance for...
Technical
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 performance of a manufacturing-scale bioreactor under various operating conditions.
Technical
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 regulatory hurdles in the life cycle of a process analytical technology application—including model...
Features
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.
Technical
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 high-performance liquid chromatography (HPLC) processing. With MCSGP, two identical reverse-phase (RP)...
Technical
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 processing times for virus filtration and polishing, and significantly improves the...
Technical
The USP <905> 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 <905> criteria. In addition, this new statistical assessment provides the same practical...