Monday, January 13, 2014

BioProcess International: Enhancing Manufacturing and Development Efficiency

Today we feature an excerpt from Maribel Rios, Managing Editor, BioProcess International 

Multiproduct facilities face additional optimization requirements associated with handling several approved products and drug substances at one site, including multiple technology transfers. Flexibility is vital for such companies. In his Tuesday presentation, Markus Wollenberg of Boehringer Ingelheim Pharma will describe how manufacturers deal with a wide range of processes (e.g., low-titer legacy and high-titer state of the art) and tech transfer projects. “Each project has its own set of priorities regarding speed, project cost, cost of goods, and risk,” he points out. His presentation will include examples of typical challenges found in multiproduct facilities and their corresponding solutions.

One well-recognized challenge in multiproduct facilities is minimizing or eliminating cross contamination. For that, industry and regulatory experts have advised manufacturers to take a risk-based approach. Such strategy can prove beneficial in flexible layouts in sites working with combinations of products, product classes, and host-cell types. In their presentation, Stephen Reich and Kristin Murray of Pfizer will share practices for selecting quality risk-management tools to identify and control cross contamination hazards across various facility designs and multiproduct operating schemes.

Paul Slaman of Shire Human Genetic Therapies will detail an example of a single-use/flexible approach to facility design. The approval of Shire's new Lexington (MA) manufacturing facility earlier this year marked a milestone in the company's implementation of single-use systems design. Slaman will provide an inside look at those systems and how the plant was designed to accommodate the growing variety of the company's therapeutic proteins.

Rizwan Sharnez of Amgen will present a case study on cleaning validation, with a focus on using cleaning characterization to streamline new product launches (coauthors Michelle Monk, Laura Klewer, Chris Flint, and Arun Tholudur, all ofAmgen). Manufacturers need strategies for addressing cleaning validation challenges for bioprocesses. According to Sharnez, such strategies “are rooted in systematic and proactive approaches to cleaning.” Examples of such approaches include small-scale “cleanability studies” to minimize at-scale cleaning validation studies, master soils to streamline and provide flexibility for scheduling cleaning validation activities, and inactivation studies to obviate the need for product-specific assays and maximum allowable carryover (MAC) assessments.

You can view the full article here. BPI will be joining us February 24-25 for the 2nd Annual Flexible Facilities Conference in Berkley, Ca. To learn more, view our agenda.

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