How a proactive approach involving predictive — rather than preventive — tools to identify deficiencies before they compound and become actual problems can result in a healthy bioprocessing facility.
How can end users ensure the expected level of compliance in this new world of single-use systems? The secret: shared responsibility for validation with your supply chain.
This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.
White paper on the risks related to bioburden downstream processing and the solutions available to mitigate these risks. Topics covered include improvements in raw material quality, equipment design, chromatography resin properties, and ways of working.
Is your team ready to manufacture larger batch sizes to support if Phase III studies are on the horizon?
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. Read on to understand strategies, frameworks and recommendations to achieve these goals.
USP <788> and equivalent regulations require that injectables are at or below particulate limits outlined in the regulation. Particulates can come from the drug ingredients, containers, tubing and equipment used in production of these products. Some products cannot be filtered prior to final fill, requiring a process which limits particulate-contributing factors wherever possible throughout manufacturing. 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.
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