As science-based organizations look to leverage the internet of things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms.
Transferring production — and the technologies that undergird it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.
The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary structure, without unintended chemical modifications, and free of extrinsic and intrinsic particles. In many cases, a lyophilized formulation can provide the highest probability of technical success. A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.
Leak testing of SUS or biocontainers, post-installation and prior to actual use, reduces the risk that a system or a biocontainer which may have been damaged during shipping, receiving, handling, storage, or installation could contribute to valuable product loss. Therefore, in cases involving high value product or complex multiple operations, leak testing may be recommended prior to use at the end-user site. This document serves to provide general guidance for experimentally establishing leak test maximum flow for SUS tested at the end-user site. It is intended to assist users in the development of parameters and maximum flow for the leak test of single-use systems when using the Palltronic Flowstar LGR test instrument.
This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production.
Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.
In the pharmaceutical and biopharmaceutical industry several factors have converged to change the landscape in regard to facilities.
As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs.
The cycle development approach described in this document is fairly universal and should not be dependant on individual isolator systems. The terminology used may be slightly different depending on the technology.
Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.
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