“只有一个inve每10000潜在的药物stigated by America’s research-based pharmaceutical companies makes it through the research and development [R&D] pipeline and is approved for patient use by the United States Food and Drug Administration [FDA],” states the Washington, D.C.-basedPharmaceuticals Research and Manufacturing Association(PhRMA, www.pharma.org). And according to PhRMA’s “Pharmaceutical Industry Profile 2010,” published in March, “it takes, on average, 10 to 15 years and an estimated $1.2 billion to $1.3 billion to create a successful new medicine.”
Does that actuality drive some current pharma trends? How could it not? “We (my colleagues and I) are seeing a very clear trend towardcontract manufacturing, especially in the API (active pharmaceutical ingredient) arena,” notes Alison Smith, vice president of marketing strategy and research at automation software supplierAspen Technology Inc.(www.aspentech.com), Burlington, Mass.
But she explains that API is “quite different” from fill/finish—the last process in pharmaceuticals production, typically implying the filling of vials and/or bottles and then any succeeding processes—in that it’s asset-intensive and requires efficient operation. “Brand owners are shedding their API assets and then purchasing the capacity back when they need it, which makes financial sense,” Smith observes.
信号一个产业转变,她的状态。“这是facilitated by better collaboration between CMO (contract manufacturing organization) partners and better quality-management practices.” Some brand owners even staff CMOs with their own personnel, Smith adds. She says that these CMOs increasingly do process design and optimization; that is, “filing NDAs (new drug applications) for the process.” However, brand owners still file paperwork for new pharmaceutical molecules, she notes.
While this particular shift unfolds, however, technology transfer remains problematic, Smith and her colleagues believe. “There is a desire to be able to share data [recipes] digitally with CMOs. This is still in the aspirational phase, which means the desire is there but supporting tools are lacking,” she says.
Even so, “electronic lab notebooks are becoming the currency of scientific data andworkflow managementon the research side of the operation,” Smith asserts. “In some cases, we are seeing them, the electronic lab notebooks, become the link between process development and manufacturing.”
R&D costly
That link is crucial. PhRMA’s “Pharmaceutical Industry Profile 2010” puts estimated industry-wide 2009 research and development (R&D) costs at approximately $65.3 billion. That means communications of any sort must be clear, accurate and actionable.
Among R&D trends, Smith notes that “the rise of contract research organizations is phenomenal. And the China market is booming: We are seeing a surge in R&D facilities and campuses being established there.” The China focus occurs because of the country’s highly educated low-cost base, and its large population of scientists and chemists, she remarks. Thus, another trend is that companies are moving robust Western pharma processes to China and, ultimately, “setting up shop to be closer to demand,” she adds.
Demand drives production, but quality ensures demand. And quality is being driven now by the quality-by-design, or QbD, concept. Its core originated with theInternational Conference on Harmonisationof Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH, www.ich.org). According to the FDA, QbD is a systematic approach, based on “sound” science and qualityrisk management. It starts with predefined objectives, and also emphasizes product and process understanding as well as process control.
“Submissions [to regulatory agencies] are getting there slowly,” Smith observes. “Companies are figuring out where to automate processes to provide the information that’s desired.” As PhRMA suggests for R&D, that may take years—and encompass even more trends and shifts throughout them.
C. Kenna Amos, ckamosjr@earthlink.net, is anAutomation WorldContributing Editor.
Pharmaceuticals Research and Manufacturing Association,PhRMA
www.pharma.org
Aspen Technology Inc.
www.aspentech.com
International Conference on Harmonisation,ICH
www.ich.org
Does that actuality drive some current pharma trends? How could it not? “We (my colleagues and I) are seeing a very clear trend towardcontract manufacturing, especially in the API (active pharmaceutical ingredient) arena,” notes Alison Smith, vice president of marketing strategy and research at automation software supplierAspen Technology Inc.(www.aspentech.com), Burlington, Mass.
But she explains that API is “quite different” from fill/finish—the last process in pharmaceuticals production, typically implying the filling of vials and/or bottles and then any succeeding processes—in that it’s asset-intensive and requires efficient operation. “Brand owners are shedding their API assets and then purchasing the capacity back when they need it, which makes financial sense,” Smith observes.
信号一个产业转变,她的状态。“这是facilitated by better collaboration between CMO (contract manufacturing organization) partners and better quality-management practices.” Some brand owners even staff CMOs with their own personnel, Smith adds. She says that these CMOs increasingly do process design and optimization; that is, “filing NDAs (new drug applications) for the process.” However, brand owners still file paperwork for new pharmaceutical molecules, she notes.
While this particular shift unfolds, however, technology transfer remains problematic, Smith and her colleagues believe. “There is a desire to be able to share data [recipes] digitally with CMOs. This is still in the aspirational phase, which means the desire is there but supporting tools are lacking,” she says.
Even so, “electronic lab notebooks are becoming the currency of scientific data andworkflow managementon the research side of the operation,” Smith asserts. “In some cases, we are seeing them, the electronic lab notebooks, become the link between process development and manufacturing.”
R&D costly
That link is crucial. PhRMA’s “Pharmaceutical Industry Profile 2010” puts estimated industry-wide 2009 research and development (R&D) costs at approximately $65.3 billion. That means communications of any sort must be clear, accurate and actionable.
Among R&D trends, Smith notes that “the rise of contract research organizations is phenomenal. And the China market is booming: We are seeing a surge in R&D facilities and campuses being established there.” The China focus occurs because of the country’s highly educated low-cost base, and its large population of scientists and chemists, she remarks. Thus, another trend is that companies are moving robust Western pharma processes to China and, ultimately, “setting up shop to be closer to demand,” she adds.
Demand drives production, but quality ensures demand. And quality is being driven now by the quality-by-design, or QbD, concept. Its core originated with theInternational Conference on Harmonisationof Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH, www.ich.org). According to the FDA, QbD is a systematic approach, based on “sound” science and qualityrisk management. It starts with predefined objectives, and also emphasizes product and process understanding as well as process control.
“Submissions [to regulatory agencies] are getting there slowly,” Smith observes. “Companies are figuring out where to automate processes to provide the information that’s desired.” As PhRMA suggests for R&D, that may take years—and encompass even more trends and shifts throughout them.
C. Kenna Amos, ckamosjr@earthlink.net, is anAutomation WorldContributing Editor.
Pharmaceuticals Research and Manufacturing Association,PhRMA
www.pharma.org
Aspen Technology Inc.
www.aspentech.com
International Conference on Harmonisation,ICH
www.ich.org
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