Large Molecule

BRIEF: Critical Trends Driving BioManufacturing Production Strategies

Industry study data details manufacturers' top priorities

By Jean-Claude Lupis, director, and Eric Langer, managing partner, BioPlan Associates Inc.

Editor's note: this is a 60-second version of the original article. To read the full length feature, click the link at the end of the brief.

The biopharmaceutical manufacturing industry has undergone many changes over the past decade, all being driven by the need for productivity and efficiency, according to BioPlan Associates' 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

This year, the industry is again focusing efforts on strategically improving its productivity to address chronic inefficiencies:

• Manufacturing productivity/efficiency (17.2 percent of global biomanufacturers)
• Downstream processing advances (11.7 percent)
• Manufacturing cost reductions (10.6 percent)
• Single-use system implementation and integration (8.9 percent)
• Biosimilars/biogenerics (8.9 percent)

Although some respondents continue to indicate they must first address acute pains such as improving their downstream processing bottlenecks and reducing costs, once these areas are attended to, we expect to see continued strategic focus on general productivity.

Some of the interesting (and likely short-term) trends related to acute operational problems include downstream processing emphasis and a drop in interest in biosimilars.

This year's top trends are all related in their drive for greater efficiency and productivity in the manufacturing process.

The biopharma manufacturing industry has witnessed substantial changes in recent years, from improved upstream titers to the advent of single-use/disposable applications. While the focus has shifted to downstream processing as part of the consistent effort to increase productivity and efficiency, there are also other changes afoot.

The emergence of single-use devices, for example, appears to dovetail with a broader industry trend towards flexible, "modular" facilities. And as the biopharmaceutical industry — and pharma sector as a whole — moves further away from blockbuster drugs and to more targeted therapies, we may see a similar shift in manufacturing paradigms, towards smaller, flexible facilities that spring up around the world, capable of handling multiple products and dominated by single-use and disposable devices

At the same time, new trends and advances are making continuous bioprocessing more cost-effective, and the industry may in time develop the technologies that close the gap with other manufacturing industries where this is already common, such as food and automobiles. All in all, it's an exciting time for the industry, which — despite its reputation as slow-changing — has seen trends in recent years beginning to transform production strategies. All signs point to a continued transformation in the years to come.

  Read the full length article

Free Subscriptions

Pharma Manufacturing Digital Edition

Access the entire print issue on-line and be notified each month via e-mail when your new issue is ready for you. Subscribe Today.

pharmamanufacturing.com E-Newsletters

A mix of feature articles and current new stories that are critical to staying up-to-date on the industry, delivered to your inbox. Choose from an assortment of different topics and frequencies. Subscribe Today.