Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.
In the pharmaceutical and biopharmaceutical industry several factors have converged to change the landscape in regard to facilities.
As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs.
The cycle development approach described in this document is fairly universal and should not be dependant on individual isolator systems. The terminology used may be slightly different depending on the technology.
Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.
In this white paper, ceramic hydroxyapatite media is used for purification of a wide variety of mammalian viruses.
One area coming under increased regulatory scrutiny is change control: the ability to manage deviations to established policies and procedures in a way that is efficient, timely and compliant.
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.
Find out the characteristics of electronic archives and history supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.
This white paper, brought to you by Dassault Systèmes BIOVIA, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.
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