Bio Pharma Manufacturing's Top 15 Trends for 2015

The quest for efficiency continues as demand fuels capacity growth and process throughput.

By Eric S. Langer and Jean-Claude Lupis, BioPlan Associates Inc.

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What's driving Bio Pharma manufacturing production in 2015? To get to that answer and rank the industry's Top 15 trends for 2015, we drew insight from our "12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production" as well as input from BioPlan's Biotechnology Industry Council, a panel of more than 500 biopharma industry subject matter experts.

1) Manufacturing efficiency and productivity — where biomanufacturers are putting most of their attention.

In an effort to reduce costs associated with bioprocessing, launch biosimilars and address other strategic issues, the top trend this year involves "productivity and efficiency." Of the 13 key areas studied, more than 27 percent of respondents to our annual study noted these, along with cost reductions as their primary focus in 2015. This is demonstrated in areas including:

• Improvements in productivity from bioreactors, where average titer for clinical-scale biologics rose to 3.4 g/L this year, compared with 1.9 g/l in 2008
• Average mammalian titer at commercial scales is 2.50 g/L and 3.41 percent at clinical production scales.

Titers will continue to increase. Downstream continues to be the area requiring technological improvements, with 19.1 percent of respondents citing "Chromatography columns" as currently causing significant or severe capacity constraints. However, downstream productivity is getting better, and key indicators like capacity constraints have declined dramatically; this year only 45 percent expected moderate or worse capacity problems, compared with 88 percent of the industry back in 2005.

2) Budgets for Biomanufacturing operations up as much as 6.1 percent; all operational budgets have increased this year.

Budgets for operational aspects of bioprocessing have increased across-the-board, from 1.9 percentage average budget increase for R&D, to 6.1 percent for new capital equipment, and 5.3 percent for process development. Budget areas can be considered an indication of where facilities are focusing their attention and resources in the coming year(s).

 3) Single-use systems and disposable devices in hot demand: 7 out of 10 top new bio-innovations are single-use.

A large majority of biomanufacturers are demanding better single-use devices, disposable chromatography, downstream purification and throw-away sensors, which lead the pack in what buyers want. More than a third are demanding more and better devices today. The most urgent problem with adopting more single-use devices is simply breakage, and loss of production material. With breakage a fairly rare occurrence, this suggests that adoption hurdles are becoming increasingly less of a problem.

Essentially all, 90 percent, of respondents report using single-use bioprocessing equipment, with "Disposable filter cartridges" cited the most, used by 94.2 percent, followed by "Tubing" and "Depth filters." Single-use bioreactors were reported as used by 73.6 percent of respondents. The single-use products with the highest reported growth in annual adoption rates (1st use in facility) were "Membrane adsorbers" with annual growth of 16.8 percent, "Mixing systems" 16.2 percent and "Bioreactors" 14.9 percent; with the lowest reported adoption rate, 1.5 percent, for "Disposable chromatography devices." Both single-use "Mixing systems" and "Bioreactors" have seen more than a 50 percent increase in adoption since 2006. More than two-thirds (68.8 percent) cited single-use equipment as improving their bioprocessing in the past year, including 73.9 percent of U.S. respondents. More than one-third of respondents cited their desire for improved single-use downstream purification equipment, including 35.7 percent citing the desire for improved chromatography equipment.

4) Healthy, 14-percent Bio Pharma industry segment growth.

Growing consistently at ~14 percent and based on sales of biologics over the past 18 years, sales of biotherapeutics are currently at $200 billion. In manufacturing, current capacity utilization is a healthy 70 percent for mammalian production; facilities expect to expand their mammalian production by 49 percent on average over the next 5 years (2020); and by 25 percent for microbial facilities.

Bioprocessing-related budgets are expanding. Companies are investing more in biomanufacturing R&D, including hiring staff and expanding manufacturing capacity. Budgets for new capital equipment continue to grow; respondents report their budget up this year by an average of 6.1 percent versus 4.4 percent last year. Budgets for process design up 5.3 percent; new facility construction budgets are at an all-time high. Overall, companies appear to be investing in increasing productivity with what they already have, e.g., process development and new technologies for downstream manufacturing receiving high budget increases.

5) Bioprocessing capacity, including among CMOs, is at a healthy level, with no capacity crunches expected. Many new facilities and expansions are recently completed, underway and planned.

Survey respondents reported an average 69.9 percent capacity utilization for mammalian cell culture and 57.9 percent for microbial fermentation. These rates are in a healthy range — not too high (with bottlenecks) and not too low. But despite this, 56.7 percent of respondents reporting having experienced at least minor capacity constraints in the past year, mostly with commercial manufacturing (a factor driving capacity expansions and new facilities). CMOs reported higher capacity utilization — 81.8 percent for mammalian cell culture and 68.3 percent for microbial fermentation — and also much higher "significant" constraints, 32.7 percent versus 10.3 percent for product developers. U.S. mammalian capacity utilization rates are higher than for Europe — 72.3 percent versus 51.4 percent, while Europe has higher microbial capacity utilization, 65.8 percent versus 55.3. Overall, 60.1 percent expect "facility constraints" as likely to create capacity constraints at their facility within the next 5 years. Respondents projected an average 5-year planned increase of 49 percent in their facility's mammalian bioreactor capacity and 25 percent increase in microbial capacity.

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