Pharmaceutical engineering

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.

Academic programs

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. 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).

A new Master of Science in Advanced Pharmaceutical Engineering (ADPHARMING) is scheduled to open in September 2016 (official accreditation n°20151034 by the French Ministry of Higher Education and Research, according to the decree of 10 july 2015, under the mention « Ingénierie de la Santé ») at Ecole des Mines d'Albi (Institut Mines-Télécom), a grande école d'ingénieur located south-west of France , with a strong industrial and academic pharmaceutical network. This master provides a global vision of international regulations, drug and process development, advanced and innovative galenics, QBD, advanced manufacturing, lean management, PAT, quality and supply chain.

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).^[1]

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.

Common specialties

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.

References

↑ P.E. Magazine: 33. May 2011. Missing or empty |title= (help)

External links

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