To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy. This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development, all in order to prepare for successful commercial production.

Advancing active pharmaceutical ingredients (APIs) through the drug product-development lifecycle is fraught with challenges. Development timelines are tight, so it’s crucial to determine early in the process if an API is a viable candidate for clinical testing. A key tool that has emerged to address these combined issues of tight timelines and complex molecules is precision powder micro-dosing in capsules. This paper describes the use of precision micro-dosing to prepare API powder-in-capsule (PIC) dosage forms for oral or pulmonary administration.

The increase in pulmonary illnesses has added to the need for drug products that are safe and efficacious. A key to efficacy is the control of the mass median aerodynamic diameter (MMAD) particle size via particle engineering. This paper explains Lonza’s inhalation and particle engineering platforms.

Finding ways to optimize the holistic preclinical development.

As process intensification is adopted into large scale manufacturing, the responsibility on scale-down models to accurately represent the expanded operating space quickly follows. Perfusion continues to be one such operating mode which lends itself to adding benefit at the manufacturing scale while adding complexity to the small-scale approach. The purpose of the described study was to develop a reliable small-scale model of our perfusion process in the ReadyToProcess WAVE 25 Rocker bioreactor and WAVE Cellbag 50 L.

Within biopharmaceutical production there is a shift from manually monitoring processes to real-time control and automated intervention. The goal is to develop algorithms and AI solutions which are able predict outcomes and create autonomous systems. The first step towards this goal is to use reliable and robust in-line sensors for real-time process control. This paper exemplifies how to use available and reliable sensors for in-process control of several different upstream and downstream process parameters.

Pharmaceutical manufacturers are striving for more diversified portfolios targeting a greater number of monoclonal antibodies (mAb), the key to driving down overall costs is to lower capital expenditure (CAPEX) investments by better utilization of equipment. This article provides an overview of a successfully designed a closed and physically connected mAb process at the pilot scale with single-use components.

Perfusion processes enable continuous operation over extended periods of time by constantly providing fresh nutrients for the cells and simultaneously removing spent media and waste products, as compared to batch and fed-batch processes. The key benefits of perfusion processes are compact process design, flexibility, increased productivity, increased yield, and consistent product quality. The purpose of the described study is to demonstrate a connected mAb perfusion cell culture process using Xcellerex XDR 50 integrated with the Xcellerex Automated Perfusion System (APS).

By leveraging early decisions around process development, quality assurance, and quality control strategies, you can set yourself up for a successful cGMP manufacturing workflow. This article will tackle how to approach process development with a manufacturing workflow mindset that will transition smoothly to cGMP manufacturing.

With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.