Overcoming challenges of improving legacy biopharmaceutical processes

Evidence: Overcoming challenges to improving quality

Overcoming Challenges of Maturity

In 2008, the systems and networks research communities find themselves victims of their own successes. This white paper reviews some of the evidence that the two areas are under enormous stress, and suggests that the situation is only going to get worse. Yet there are a number of simple steps we can take to reduce stresses if we start by asking ourselves what motivates the various parties invol...

Overcoming the Prevalent Decomposition in Legacy Code

The potential benefits of advanced separation of concerns (ASOC) techniques are well known and many programmers find the idea of using them appealing. For new software engineering projects these modularization mechanisms offer guidelines of how to structure the system modules. But how can legacy systems profit from them? Code related to concerns not represented in the current modularization has...

New Challenges for Biopharmaceutical Process Development.PDF

The U.S. Food and Drug Administration (FDA), through the Center for Biologics Evaluation and Research (CBER)/Center for Drug Evaluation and Research (CDER), has long identified that the development of biopharmaceutical products is becoming increasingly challenging, and is inefficient and costly. The agency has also commented that superior product-development sciences are needed to address the c...

Standardization and Certification Challenges for Biopharmaceutical Plants

C O M P U T E R 0 0 1 8 9 1 6 2 / 1 7 / $ 3 3 . 0 0 © 2 0 1 7 I E E E P U B L I S H E D B Y T H E I E E E C O M P U T E R S O C I E T Y S E P T E M B E R 2 0 1 7 83 Bioprocessing—a technique that produces biological material, such as genetically engineered microbial strains and commercially useful chemicals—is big business in the US and growing quickly around the world. An increasing number of ...