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Pharmaceutical engineering is a branch of pharmaceutical science and technology that involves development and manufacturing of products, processes, and components in the pharmaceuticals industry (i.e. drugs & biologics). While developing pharmaceutical products involves many interrelated disciplines (e.g. medicinal chemists, analytical chemists, clinicians/pharmacologists, pharmacists, chemical engineers, biomedical engineers, etc.), the specific subfield of "pharmaceutical engineering" has only emerged recently as a distinct engineering discipline. This now brings the problem-solving principles and quantitative training of engineering to complement the other scientific fields already involved in drug development.
There are still relatively few academic programs with this explicit focus. The first one began at the University of Michigan, as a joint project between their College of Engineering and School of Pharmacy. In Asia, the PhD program in pharmaceutical engineering is available in Thailand, for example, at Faculty of Pharmacy, Silpakorn University (since 2009). A new innovative program was launched in Albi, France by Ecole des Mines-Albi - IMT in september 2016, dedicated to advanced pharmaceutical engineering (ADPHARMING). Because such programs are not yet common, many pharmaceutical engineers have had their formal engineering training in chemical or biomedical engineering.
Most pharmaceutical engineering programs are graduate-level, and as with biomedical engineering there is generally an expectation that engineers and scientists working in pharmaceutical engineering should have some relevant graduate-level education. Many have a masters or PhD degree in chemical or biomedical engineering, or a related science. In Italy there is a university degree course (5 years) in Chemistry and Pharmaceutical Technologies (Chimica e Tecnologie Farmaceutiche), different from pharmacy, that ability as a pharmacist and different roles in the industry as an engineer (for the Italian legislation is not really an engineer though performs the same tasks).
Professional licensure and certification
In most jurisdictions, engineering licensure (e.g. Licensed "Professional Engineer" or P.E.) is not discipline-specific, so any licensed engineer with competency in pharmaceutical engineering may qualify as licensed. However, in the U.S., most pharmaceutical engineers fall under the "industrial exemption," which does not require a (P.E.) license for those engineers whose work is completely internal and for a private employer. There are ongoing debates about whether to narrow or eliminate this exemption from engineering licensure, and the Executive Director of the National Society of Professional Engineers (NSPE) recently advocated requiring licensure for engineers in the pharmaceutical industry (among a few others).
Most U.S. jurisdictions require two examinations as part of their licensing criteria, the second of which allows electing a particular discipline of emphasis (while not affecting the license itself, as noted above), so pharmaceutical engineers are likely to select the testing option of either chemical engineering or biomedical engineering (which are generally considered the closest available options).
There is also a private (non-governmental) certification offered by the professional organization International Society for Pharmaceutical Engineering (ISPE), known as Certified Pharmaceutical Industry Professional (CPIP). This tends to focus more on (later-stage) manufacturing and commercialization issues, etc., rather than early-stage things like drug design, discovery assays, and preclinical development.
- Pharmaceutical Development Sciences - broadly, assays or techniques for discovering, modifying, or designing drug substances or excipients; in particular, rational drug design - as a relatively recent alternative to traditional trial-and-error drug discovery processes - relies upon principles of engineering more than many other pharmaceutical sciences such as formulation or medicinal chemistry.
- Bio-/Pharmaceutical Manufacturing Science - optimal processes for producing drug substances & products with quality and efficiency
- Clinical Science - applying engineering principles toward conduct of studies to assess safety & efficacy, for the medical community and regulators
- Regulatory Science - scientific bases for regulatory decision-making (typically by the FDA, in the U.S.), with an emphasis on risk-benefit analysis
- Pharmaceutical Devices - designing instruments, tools, or implants which facilitate the making, handling, or use of drugs (e.g. drug delivery chips)
These specialties overlap with other engineering areas as well as non-engineering scientific and medical fields, although in all specialties Pharmaceutical Engineers tend to have a distinct focus on product and process design and quantitative analysis. And in addition to these technical areas, some pharmaceutical engineers pursue careers as business or legal professionals. Their scientific and engineering background is often suitable for careers in management, patent law, or even entrepreneurship - for example.
- Pharmaceutical Sciences
- Chemical Engineering
- Biomedical Engineering
- International Society for Pharmaceutical Engineering