Pharmaceutical engineering is a branch of
engineering
Engineering is the practice of using natural science, mathematics, and the engineering design process to Problem solving#Engineering, solve problems within technology, increase efficiency and productivity, and improve Systems engineering, s ...
focused on
discovering,
formulating, and manufacturing
medication
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmaco ...
, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs. It utilizes the fields of
chemical engineering
Chemical engineering is an engineering field which deals with the study of the operation and design of chemical plants as well as methods of improving production. Chemical engineers develop economical commercial processes to convert raw materials ...
,
biomedical engineering
Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications (e.g., diagnostic or therapeutic purposes). BME also integrates the logica ...
,
pharmaceutical sciences, and
industrial engineering
Industrial engineering (IE) is concerned with the design, improvement and installation of integrated systems of people, materials, information, equipment and energy. It draws upon specialized knowledge and skill in the mathematical, physical, an ...
.
History
Humans have a long history of using derivatives of natural resources, such as plants, as medication. However, it was not until the late 19th century when the technological advancements of chemical companies were combined with medical research that scientists began to manipulate and engineer new medications, drug delivery techniques, and methods of mass production.
Synthesizing new medications
One of the first prominent examples of an engineered, synthetic medication was made by
Paul Erlich. Erlich had found that
Atoxyl, an arsenic-containing compound which is harmful to humans, was very effective at killing ''
Treponema pallidum
''Treponema pallidum'', formerly known as ''Spirochaeta pallida'', is a Microaerophile, microaerophilic, Gram-negative bacteria, gram-negative, spirochaete bacterium with subspecies that cause the diseases syphilis, bejel (also known as endemic ...
'', the bacteria which causes
syphilis
Syphilis () is a sexually transmitted infection caused by the bacterium ''Treponema pallidum'' subspecies ''pallidum''. The signs and symptoms depend on the stage it presents: primary, secondary, latent syphilis, latent or tertiary. The prim ...
. He hypothesized that if the structure of Atoxyl was altered, a "magic bullet" could potentially be identified which would kill the parasitic bacteria without having any adverse effects on human health. He developed many compounds stemming from the chemical structure of Atoxyl and eventually identified one compound which was the most effective against syphilis while being the least harmful to humans, which became known as
Salvarsan
Arsphenamine, also known as Salvarsan or compound 606, is an antibiotic drug that was introduced at the beginning of the 1910s as the first effective treatment for the deadly infectious diseases syphilis, relapsing fever, and African trypanosomias ...
. Salvarsan was widely used to treat syphilis within years of its discovery.
Beginning of mass production

In 1928,
Alexander Fleming
Sir Alexander Fleming (6 August 1881 – 11 March 1955) was a Scottish physician and microbiologist, best known for discovering the world's first broadly effective antibiotic substance, which he named penicillin. His discovery in 1928 of wha ...
discovered a mold named ''
Penicillium chrysogenum
''Penicillium chrysogenum'' (formerly known as ''Penicillium notatum'') is a species of fungus in the genus ''Penicillium''. It is common in temperate and subtropical regions and can be found on salted food products, but it is mostly found in in ...
'' which prevented many types of bacteria from growing. Scientists identified the potential of this mold to provide treatment in humans against bacteria which cause infections. During
World War II
World War II or the Second World War (1 September 1939 – 2 September 1945) was a World war, global conflict between two coalitions: the Allies of World War II, Allies and the Axis powers. World War II by country, Nearly all of the wo ...
, the United Kingdom and the United States worked together to find a method of mass-producing
penicillin
Penicillins (P, PCN or PEN) are a group of beta-lactam antibiotic, β-lactam antibiotics originally obtained from ''Penicillium'' Mold (fungus), moulds, principally ''Penicillium chrysogenum, P. chrysogenum'' and ''Penicillium rubens, P. ru ...
, a derivative of the ''Penicillium'' mold, which had the potential to save many lives during the war since it could treat infections common in injured soldiers. Although penicillin could be isolated from the mold in a laboratory setting, there was no known way to obtain the amount of medication needed to treat the quantity of people who needed it. Scientists with major chemical companies such as
Pfizer
Pfizer Inc. ( ) is an American Multinational corporation, multinational Pharmaceutical industry, pharmaceutical and biotechnology corporation headquartered at The Spiral (New York City), The Spiral in Manhattan, New York City. Founded in 184 ...
were able to develop a
deep-fermentation process which could produce a high yield of penicillin. In 1944, Pfizer opened the first penicillin factory, and its products were exported to aid the war efforts overseas.
Controlled drug release
Tablets for oral consumption of medication have been utilized since approximately 1500 B.C.; however, for a long time the only method of drug release was immediate release, meaning all of the medication is released in the body at once.
In the 1950s,
sustained release
Modified-release dosage is a mechanism that (in contrast to immediate-release dosage) delivers a drug with a delay after its administration (delayed-release dosage) or for a prolonged period of time (extended-release R, XR, XLdosage) or to a spe ...
technology was developed. Through mechanisms such as
osmosis
Osmosis (, ) is the spontaneous net movement or diffusion of solvent molecules through a selectively permeable membrane, selectively-permeable membrane from a region of high water potential (region of lower solute concentration) to a region of ...
and diffusion, pills were designed that could release the medication over a 12-hour to 24-hour period.
Smith, Kline & French
Smith, Kline & French (SKF) was an American pharmaceutical company that is now a part of the British group GSK plc.
History
In 1830, John K. Smith opened a drugstore in Philadelphia, and his younger brother, George, joined him in 1841 to form ...
developed one of the first major successful sustained release technologies. Their formulation consisted of a collection of small tablets taken at the same time, with varying amounts of wax coating that allowed some tablets to dissolve in the body faster than others. The result was a continuous release of the drug as it travelled through the intestinal tract. Although modern day research focuses on extending the controlled release timescale to the order of months, once-a-day and twice-a-day pills are still the most widely utilized controlled drug release method.
Formation of the ISPE
In 1980, the International Society for Pharmaceutical Engineering was formed to support and guide professionals in the pharmaceutical industry through all parts of the process of bringing new medications to the market. The ISPE writes standards and guidelines for individuals and companies to use and to model their practices after. The ISPE also hosts training sessions and conferences for professionals to attend, learn, and collaborate with others in the field.
See also
*
Drug discovery
In the fields of medicine, biotechnology, and pharmacology, drug discovery is the process by which new candidate medications are discovered.
Historically, drugs were discovered by identifying the active ingredient from traditional remedies or ...
*
Drug development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regu ...
*
Modified-release dosage
Modified-release dosage is a mechanism that (in contrast to immediate-release dosage) delivers a drug with a delay after its administration (delayed-release dosage) or for a prolonged period of time (extended-release R, XR, XLdosage) or to a spe ...
*
Pharmaceutical manufacturing
*
Pharmaceutical industry
The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing ...
References
{{reflist
Drug manufacturing