Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.
By dispelling the myths associated with biocatalysis, a manufacturer can reap the benefits of this technology, providing a route to greener, safer chemistry that delivers a higher overall yield.
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.
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.
Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.
Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets
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.
In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.
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