Search results for " monitoring" in Articles / App Notes
Article
Applying GMPs to the BioPharma Supply Chain
They need to have tools that are fit for purpose, including measurement procedures for monitoring and controlling variation (e.g., tools and concepts such as statistical process control, process capab…
Article
Climate Change in Outsourcing
Most major bio/pharma companies have turned over virtually all of their clinical monitoring and data management activities and staff to major CROs.
On the manufacturing and product development sid…
Article
Biotechnology Innovation and Growth in Israel
In recent years, the Ministry of Health has developed strong capabilities in the areas of health technology assessment (HTA), new technology prioritization, and quality monitoring for community-based …
Article
Implementing QbD in Sterile Manufacturing
To gain perspective on the implementation of quality by design (QbD) in sterile manufacturing, BioPharm International spoke with Wolfgang Weikmann, vice-president quality assurance at Vetter Pharma-Fe…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
Article
Navigating Emerging Markets: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East.
The Middle East and North Africa have been rocked in recent years by upheaval ranging from moderate protest to full…
Article
The use of Xcellerex™ mixing system as slurry tank when packing chromatography columns
This application note describes the performance of single-use Xcellerex XDM Quad Mixing System used as a slurry tank when packing chromatography columns. The capability of the mixing system to keep …
Article
The Future of Biopharma
…sion
• high-tech expression systems and other genetic engineering advances
• automation, monitoring, and process control
• bioprocess modeling
• modular facilities adaptable to new en…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
Article
Quality by design for biotechnology products—part 1
Validation and implementation of drug-dependent antibody assays in clinical trials for safety monitoring of patients dosed with roxifiban, an orally bioavailable glycoprotein IIb/IIIa antagonist. J Ph…