As the nature of the target molecule becomes increasingly challenging, the need is to move away from the current linear and siloed drug development approach.
In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.
AkzoNobel is a leading worldwide producer of decorative paints, performance coatings and specialty chemicals headquartered in Amsterdam, The Netherlands. They supply industries and consumers with innovative products in four key market segments: buildings and infrastructure, transportation, consumer goods and industrial applications. The company has approximately 50,000 employees in over 80 countries and more than 200 production sites.
In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.
Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.
For many years lyophilisation, or freeze drying, has been used to dry samples in the laboratory. There are a number of potential drawbacks encountered with the conventional freeze drying apparatus.
Biogen’s Cambridge Manufacturing Facility leaders assessed their paper-based SOP delivery system. Their findings were that their procedures were inefficient and costly.
The IAB Technology Laboratory recently released OpenDirect 2.0, an update that will expand functionality within this vital transactional specification for premium automated guaranteed buying and selling