White papers are sponsored content and is the sole responsibility of the authors and is not endorsed, reviewed, nor a published article of Pharmaceutical Engineering® magazine or ISPE.
With any successful manufacturing endeavor, eventually, demand will exceed manufacturing capabilities. When this happens, scaling up from a laboratory or pilot plant is critical for meeting increased production demands. However, there are many changing variables that need to be considered when you are looking to scale up a process.
This application note shows how TOC analyzers and common sensors in the industry recover 11 different compounds most often used in water and product analysis.
Since human therapeutics have rapidly evolved from small molecules to include complex biological products such as monoclonal antibodies (mAbs), viral vectors, autologous and allogeneic cell therapies, mRNA therapeutics, drug manufacturers and contract development and manufacturing organizations (CDMO) are considering how to design and operate multiproduct facilities to maintain agility and...
Data integrity is critical in the life sciences industry because it ensures that the end product meets all the required quality standards. It is a process of maintenance and assurance of accuracy and consistency of the data over its entire lifecycle. If the integrity of the data you collect and record is not maintained, there would be no way to ensure that you are producing high-quality and...
Data integrity is critical in the life sciences industry because it ensures that the end product meets all the required quality standards. It is a process of maintenance and assurance of accuracy and consistency of the data over its entire lifecycle. If the integrity of the data you collect and record is not maintained, there would be no way to ensure that you are producing high-quality and...
Water is a key component in the pharmaceutical industry. It functions as an ingredient, a cleaning agent, a reagent, a solvent and a product, throughout the drug discovery process, from the initial identification of potential drug targets, all the way to the manufacture and quality control of the final product.
Cleaning and microbial contamination control are critical focus areas in pharmaceutical and medical device industries. Robust cleaning and disinfection programs are needed to meet the required cleanroom microbial grades, to prevent cross contamination and subsequent microbial contamination of products. This white paper reviews the latest cleaning and disinfection updates in the newly revised...
The growing expansion of gene therapy research in urban laboratory facilities presents a tremendous opportunity for high-throughput bioreactor applications. Recent advancements in bioreactor automation have improved lab efficiency and provided a critical experimental advantage in early discovery and process development work. These high throughput bioreactors can reduce risk while...
It can be confusing for business stakeholders and quality teams when it comes to the what and the why of transitioning from Computer System Validation (CSV) to Computer Software Assurance (CSA). CSA requires organizations to change their validation efforts from documenting extensive test suites to focusing on more critical thinking up front. Determining the areas of the business process and/or...
After six years in review, the final emergence of Annex 1 in August 2022 has either been a consolidation of accepted practice and wisdom or a rude awakening for many! However, it is universally accepted that it is decades' most significant single change to regulatory approach. As Annex 1 deals with products made in Europe, or products intended for Europe, it is likely to have a significant...