eBook: Biopharmaceutical Manufacturing Trends 2013 - A Rapidly Changing Landscape

Today, we feature a guest post from BioProcess International media partner PharmaManufacturing.com.  Want to join them at BioProcess International taking place this September 16-18, 2013, in Boston, MA? As a reader of this blog when you register to join us and mention code BLOG13JP and save 20% off the standard rate.

eBook: Biopharmaceutical Manufacturing Trends 2013 - A Rapidly Changing Landscape

Selection: SINGLE-USE SYSTEM INTEGRATION

Although analytical assays rank towards the top of biomanufacturers’ new product development interests, single-use, disposable products are at or near the top of the list. Preliminary data from the study reveals that end-users are interested chiefly in disposable products, bags and connectors (49%), while also expressing a desire for improvements in disposable probes and sensors (30%), disposable bioreactors (29%), and disposable purification (29%). These areas have been consistently in demand for several years now.

Disposable devices continue to make advances in manufacturing and are becoming increasingly common in most areas of biopharmaceutical production. Although, as yet, there are few non-rigid single-use devices (e.g., bioreactor bag liners) used in commercial scale GMP applications, it is likely this will change quickly as new products move through the development pipeline and out of clinical-scale manufacturing. Further, as regulators gain familiarity with the safety profiles and materials used in such devices, necessary approvals for product manufacture are apt to accelerate as well. When this occurs, the market volume for single-use devices is likely to increase significantly.

This year, 22% of the Biotechnology Industry Council members surveyed believed that single-use system integration would be the key trend for the year. Within this burgeoning area, participants identified several sub-trends.

These include:

• • Building quality into single-use operations to further reduce regulatory activities/oversight;
• • Fixing disposable bioreactors that create inconsistent growth due to changes in resins, films, gamma irradiation, and cell line specificity;
• • Downstream operations using membrane adsorbers;
• • Emergence of flexible and modular biomanufacturing facilities;
• • Establishing leachables and extract ables guidance for testing;
• • Improved upstream contamination investigations from a QA perspective;
• • Introducing single-use devices at GMP commercial scale manufacturing; and
• • Leachables and extractables [standardization] at clinical and commercial scale.

There are two interwoven trends worth an additional look. The first regards leachables and extractables. Last year, there were reported problems with the reliability and performance of available disposable solutions, with leachables and extractables a key factor. As Rick Johnston, Ph.D., CEO of Bioproduction Group Inc. noted, these issues “undermined confidence in the ability for … manufacturers to supply material in a timely manner to support production. This led many biomanufacturers to aggressively pursue dual-sourcing and risk-mitigation strategies like holding large inventories, both of which raise overall production costs. It is hoped that in the 2013 time period these issues can be resolved to allow the promise of disposables to be realized in the biomanufacturing setting.”

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