Trends in Bioprocessing - Pharmaceutical Technology

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Trends in Bioprocessing
The second annual Pharmaceutical Technology Bioprocessing Survey offers a snapshot of the industry following 2009's megamergers.This article contains online-exclusive bonus material.


Pharmaceutical Technology
Volume 34

Outsourcing


Figure 6: Process analytical technologies used (multiple answers allowed).
With announced layoffs and restructuring, we'd expect increased plans to use outside contract manufacturing and development services, but there seems to be no appreciable increase over last year. Thirty-three percent (versus 30% last year) say their companies intend to outsource some aspect of their biotherapeutic manufacturing program, whereas 51% do not (versus 50% last year). Interestingly, the reasons for outsourcing have changed somewhat.

This year, fewer respondents—45%, compared with 59% last year—say their companies lack biomanufacturing capacity, and 41% versus 45% last year, cite cost effectiveness. More respondents, 30% this year as opposed to 25% last year, say their companies outsource because they've increased manufacturing output—by increasing the number of products they manufacture, or by increasing the volume output of existing products. Fewer respondents say their companies lack the expertise in house, with only 13% citing that as a reason this year compared with 19% last year.


Figure 7: Current technical challenges faced by manufacturers of cells for tissue or cell-based therapies (multiple answers allowed).
Among those who do outsource, 49% outsource the manufacture of both drug substances and finished products, down 14% from 63% last year (see Figure 5). Forty-two percent outsource API manufacture, and 31% outsource finished products. Thirty-nine percent outsource the manufacture of materials for clinical trials, and 34% outsource their full-scale commercial manufacturing. Twenty-six percent outsource process development activities, and 19% outsource formulation development.

Quality by design

It's been a few years since FDA rolled out its quality-by-design (QbD) initiative, and we would have anticipated that more companies would have incorporated QbD principles into their manufacturing paradigm. So it came as something of a surprise to see a slight decline in respondents reporting the use of QbD in their biopharmaceutical manufacturing operations—67% this year, versus 70% last year. Nevertheless, 13% more respondents say they understand the initiative this year, bringing the percentage up to 62%. Furthermore, only 38% say they lack guidance and direction from regulatory agencies, as compared with 46% last year, and 23% more respondents than last year see the process and quality advantages to the QbD program. In spite of the fact that more respondents understand and appreciate the benefits of QbD, 17% cite cost as an impediment to implementation.


Figure 8: Current technical challenges faced by manufacturers of nucleic-acid based drugs (multiple answers allowed).
Among those who do incorporate QbD, 71% say it has improved process understanding, 51% say they've seen improvements in product quality, 49% say they've realized greater manufacturing efficiencies, and 45% say QbD has reduced variability in product quality. Twenty-eight percent say the initiative has reduced costs, but this is down from 38% who said the same thing last year. Finally, 23% credit QbD with speeding regulatory approvals.

Fifty-three percent of respondents incorporate process analytic technologies (PAT) into their manufacturing operations, about the same as last year. Among those who do use PAT, the most widely used technology is high-performance liquid chromatography (HPLC) (73%), followed by 46% who use spectroscopy (other than near infrared spectroscopy [NIR] or Fourier transform infrared spectroscopy [FT-IR]), 43% who use chromatography (other than HPLC or ultra-performance liquid chromatography), 31% who use NIR, and 28% who use FT-IR (see Figure 6).

Spending


Figure 9: Purification technologies used by respondents for manufacturing proteins (multiple answers allowed).
This year, as we hopefully recover from the recession, one might expect spending to increase over last year. This year, 31% of respondents anticipate their companies to increase spending on biopharmaceutical manufacturing activities. But if history is any predictor, respondents tend to underestimate spend. Last year, 29% anticipated spending increases in 2009, compared with 41% percent of respondents who report that their companies actually did increase spending.


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Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
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Source: Pharmaceutical Technology,
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