According to over 200 life sciences companies surveyed, the number one challenge in speeding products from R&D to patients is quality management, which may surprise many executives that have spent the past decade focused on other issues like validation, regulatory, or supply chain.
The latest in automated lubrication systems ensure optimum equipment performance — even in demanding pharmaceutical manufacturing environments — and reduce unscheduled maintenance.
With biologics filling the pipelines of life sciences companies more than ever, the biopharmaceutical industry needs to rethink its view of quality. Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.
“Why do you need this laboratory information management system (LIMS)?” “We have an enterprise resource planning (ERP) system, why do we need to purchase yet another software product?” “How will the system you’re recommending improve lab operations?”
To ensure quality of pharmaceutical raw materials and products, it is very important to monitor specific factors throughout supply chain. In cold chains, temperature is closely controlled and monitored.
In spite of the headline, it is difficult to pin point the one single most common mistake. This articles focuses on what not to do, or what to avoid, during the mapping process.
Information gathered in a manufacturing environment equips a facility with the tools to react to issues in real time and respond more quickly to customer requests.
Most chamber mapping projects that fail do so because of inadequate preparation. Poor or inadequate preparation for the mapping study can lead to a failed mapping study, which can lead to unnecessary costs in valuable biopharmaceutical production time or regulatory and product quality issues.
In our application notes and articles about environmental management in pharmaceutical, biotechnology, and medical device applications we usually stay at the level of principles because every scenario is different. Guidance documents are written broadly for just this reason: the needs of each product and the parameters of each environment will, more than all other factors, determine how you will apply regulations and guidance.
Despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Here are key areas where pharma manufacturers face the biggest uphill battles.
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