At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.
The road to take a drug compound from discovery to commercialization is long, expensive and often fraught with unforeseen challenges. While every project will undoubtedly face some bumps along its path, far too many programs hit insurmountable obstacles that require innovators to backtrack and correct their course before proceeding, further extending timelines and adding costs.
Without careful consideration of what are the most important features you need from a CMO and preparing for what the CMO needs from you, the result can be a mismatch.
“Digital transformation” is a common buzzword across industries today, but is it more than just jargon? Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way.
In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.
Setting up a perfusion process is complex, and getting the best out of it requires an awareness of the do’s and don'ts of the approach. Design of experiment (DoE) and quality by design (QbD) approaches help the development of a production process that is both cost-effective and high quality.
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.
Understand how the more support and guidance small biopharmaceutical companies receive in terms of CMC expertise, the better groundwork it will lay for a successful IND filing.
In a scenario where manufacturing processes move to a continuous flow, analyzers are producing data simultaneously, necessitating real-time processing and making the existence of cloud-based tools for data management crucial.
Here, we will discuss the costs and risks of taking a fragmented approach to managing and moving drug supplies and will explain how those risks can be mitigated.
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