BioPlan Associates Inc. recently released its Top 15 Trends in Biopharmaceutical Manufacturing, which provides analysis of data from the firm’s 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. BioPlan has drawn these insights, and the ranking of trends based on an internal analysis of the most commonly discussed industry problems, and from input from their Biotechnology Industry Council, a panel of over 500 biopharma industry subject matter experts. Herein we address the Top 5 trends. The full list will be published in the upcoming September print edition of Contract Pharma, so be sure to tune in.

Trend #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, over 27% of respondents to the 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% at clinical production scales. Titers will continue to increase.
• Downstream continues to be the area requiring technological improvements, with 19.1% 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% expected moderate or worse capacity problems, compared with 88% of the industry back in 2005.

Trend #2
Budgets for biomanufacturing operations up as much as 6.1%; all operational budgets have increased this year

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

Trend #3
Single-use systems and disposable devices in hot demand: 7 of 10 top new bio-innovations are single-use; expect more adoption of single-use systems, including for commercial manufacture

A large majority of biomanufacturers are demanding better single-use devices—disposable chromatography, downstream purification and throw-away sensors lead the pack in what buyers want. Over 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, noted by 75%. With breakage a relatively rare occurrence, this suggests that adoption hurdles are becoming increasingly less of a problem. Essentially all, 90%, of respondents report currently using single-use bioprocessing equipment, with disposable filter cartridges cited the most, used by 94.2%, followed by tubing and depth filters.

Single-use bioreactors of any size were reported as used by 73.6% of respondents. The single-use products with the highest reported growth in annual adoption rates (first use in facility) were membrane adsorbers with annual growth of 16.8%, mixing systems 16.2% and bioreactors 14.9%. The lowest reported adoption rate, 1.5%, was for disposable chromatography devices. Both single-use mixing systems and bioreactors have seen over a 50% increase in adoption since 2006. Over two-thirds (68.8%) cited single-use equipment as improving their bioprocessing in the past year, including 73.9% of U.S. respondents. Over one-third of respondents cited desires for improved single-use downstream purification equipment, including 35.7% citing desires for improved chromatography equipment.

Trend #4
Healthy 14% biopharma industry segment growth

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

Bioprocessing related budgets are expanding in essentially all areas. Companies are investing more in biomanufacturing-related 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% vs. 4.4% last year. Budgets for process design are up 5.3%. At the same time, 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.

Trend #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% capacity utilization for mammalian cell culture and 57.9% for microbial fermentation. These rates are in a health range—not too high, with bottlenecks, and not too low, but high enough to be cost effective. But despite this, 56.7% of respondents reported 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% for mammalian cell culture and 68.3% for microbial fermentation—and also much higher significant constraints, 32.7% vs. 10.3% for product developers. U.S. mammalian capacity utilization rates are higher than for Europe—72.3% vs. 51.4%—while Europe has higher microbial capacity utilization—65.8% vs. 55.3. Overall, 60.1% 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% in their facility’s mammalian bioreactor capacity and 25% increase in microbial capacity.

Interested in learning more? Look for trends 6-15 in the upcoming September edition of Contract Pharma.

And for full information on BioPlan’s Annual Report, visit: www.bioplanassociates.com/12th