There are a number of factors to be taken into consideration when selecting containers for use within a critical environment.
With patient care at the forefront, it is critical to assess the economics of both outsourcing models and ensure the one you select provides the most efficient path to commercialization. This was the purpose of a recent study by the Tufts Center for the Study of Drug Development (CSDD), which compared cycle times and development economics between multi- and single-source CDMO models.
Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.
A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable.
Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.
If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy.
In a scenario where manufacturing processes move to a continuous flow, analyzers are producing data simultaneously, necessitating real-time processing and cloud-based tools for data management.
Drug substance characterization is critical to drug product formulation but characterization and formulation are often not integrated during drug development.
With their unique separation behaviors and tolerance for relatively high salt concentrations, mixed-mode resins have become important tools in the process developer’s toolbox.
The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.
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