The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.
How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.
Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult.
Some products cannot be filtered prior to final fill, requiring a process which limits particulate-contributing factors wherever possible. Pre-cleaned, sterile, ready-to-use containers ease this burden.
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.
This white paper focuses on how a structured and transparent risk management process can align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees.
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