News Feature | April 28, 2014

Study Finds Pharma Manufacturing Model Impedes Innovation

By Lori Clapper

CPhI, a provider of innovative, interactive, and educational programs to network, learn, and gain new insights into the world of pharma, released new insights last week into current pharmaceutical manufacturing practices and processes. 

The study, Analyzing Pharma Industry Trends and Techniques, found that 70 percent of the industry says it is “actively investing in manufacturing techniques and technologies.” As a whole, the industry recognizes the significant need to improve manufacturing processes to improve drug quality, gain process efficiency, and ultimately cut costs and make profits. However, the consensus found the current manufacturing model is “impeding innovation and preventing wide-spread adoption” of methods to accomplish these goals.

While companies are starting to adopt continuous processing for efficiency savings, it was apparent that more can and should be done to revolutionize the industry.

The quest for quality

The focus on quality is no surprise, given the recent rise of drug quality issues in the global pharma manufacturing industry. However, manufacturers have begun to utilize more modern quality control methods, including:

  • Process control: 25 percent
  • Process capability analysis: 21 percent
  • Quality by Design (QbD): 16 percent
  • Six Sigma: 12 percent
  • Lean/kaizen: 11 percent
  • PAT: 11 percent

"With the majority of the industry now committed to process improvements and increased product quality, the next few years will hopefully see more new manufacturing methods coming to market, with tighter process controls,” Chris Kilbee, group director, pharma, said.

“These should ultimately reduce costs and increase profits for the industry."

While pharma companies agreed that quality was their main focus, the study shows that 11 percent didn’t test all raw materials sent into their facilities. Of the 89 percent that are testing raw materials sourced to their facilities, compendial testing was the method of choice (81 percent) and is likely to stay that way for the next few years.

Pharma financials

Overall, CPhI found the pharma manufacturing industry in good health:

  • 59 percent are planning to hire, with only four percent planning reductions.
  • 41 percent are outsourcing more of their manufacturing.
  • Nearly 50 percent of the industry launched more than three products last year, with 41 percent planning to add one to three products.

The researchers concluded that for quality goals to be reached, the industry must be willing to implement improvements from process development to commercialization for all new products.