Module 2 Flashcards
__________ involves the research, development, creation, and manufacturing of drugs.
Pharmaceutical engineering
Pharmaceutical engineering focuses on _______________
designing, building, and
improving manufacturing facilities that produce drugs. Although some
pharma engineers also work with discovering and formulating drugs.
Pharmaceutical engineers perform the following specific job duties:
- Conceptualizing and designing products
- Synthesizing and testing compounds
- Setting safety and quality protocols
- Measuring potential side effects and stability issues
- Manufacturing products
- Labeling products and ensuring they comply with regulations
- Packaging products to optimize their distribution
____________ sets the standard for how
pharmaceutical engineers should perform their jobs to help minimize the
risks involved with pharmaceutical production.
Good Manufacturing Practice (GMP)
GMP is promulgated by the US Food and Drug Administration under the
authority of the _________. These
regulations, which have the force of law, require that manufacturers,
processors, and packagers of drugs, medical devices, some food, and
blood take proactive steps to ensure that their products are safe, pure, and
effective.
Federal Food, Drug, and Cosmetic Act.
Four Pillars of Pharmaceutical Engineering
API and Biotech
Dosage Form Manufacturing
Fill and Finish
Assembly and Packing
On a basic level, drugs consists of two parts: the _____________ and the chemically inactive _______.
active pharmaceutical
ingredient (API); excipient
Biotech and Biopharmaceuticals involve utilization of _______, but other
systems are utilized for specialized products such as vaccines.
either microbial or mammalian expression systems
Additionally, the industry is facing new challenges,
- Antibody drug conjugates (ADC) for cancer treatment
- New vaccine technologies (vectors and nucleic acid vaccines)
Facilities need to be built in a flexible way to support a broad range of
____________.
manufacturing technologies as well as volume requirements
API & Biotech requirements range from extremely small volumes needed
for _________.
personalized medicine, a few hundred kilos for orphan drugs, and tons of products for common diseases like diabetes, arthritis and cancer
MIT Researchers aimed to create an _______________ for the continuous manufacturing of_______________.
On-Demand Pharmacy; ciprofloxacin
The most common way of delivering an active pharmaceutical ingredient today is through a tablet, which we call an _________.
oral solid dosage (OSD)
Manufacturing facilities for OSD products are still the
most common pharmaceutical manufacturing facilities. However, most of the traditional blockbuster OSD products are now ______________
off-patent.
New OSD products – which are of a higher ______ - are typically for smaller volumes, requiring a high
_______ manufacturing set-up.
potency; flexible
Dosage Form Manufacturing Pressures
- How to make production more cost-effective.
- Innovative delivery platforms (e.g., sustained release, sprays and chewing
gum). - Generic manufacturers increasing production capacity.
- Regulatory requirements and health, safety and environmental standards
evolving through the years.
Fill and Finish: ____________ are very important – the actual filling of the
pharmaceutical product on any dosage form is a highly critical part of the
manufacturing process.
Sterility and correct dosage
A growing trend of small batch sizes is pushing manufacturers to increase
the __________________
level of flexibility of aseptic production..
Levels of flexibility of aseptic production.
- Facilities accommodating multiple products.
- Increase productivity for smaller batches.
- Prevent contamination.
- Minimize number of rejects.
______________ is the process of filling commercially sterilized products into
pre-sterilized containers.
Aseptic filling
The containers are sterilized using one of four techniques:
- Heat: hot air, steam
- Mechanical: water, brushing
- Irradiation: infrared, ultraviolet rays
- Chemical: hydrogen peroxide, chlorine
Although not as critical as product filling, optimized _________ can be a crucial differentiator when it comes to
price.
assembly and
packaging processes
The modern pharmaceutical packaging world prompts challenges that
significantly influence manufacturing costs which may indicate an
increase in _________ which will then impact __________.
stock keeping units; efficiency
modern pharmaceutical packaging world
- Compliance, quality and tracking of products
- Trends of serialization
- Late-stage customization
- Patient-centricity
7 Types of Pharmaceutical Packaging
- Bottle packaging
- Syringe packaging
- Blister packaging
- Ampoules packaging
- Vials packaging
- Sachet packaging
- Cardboard carton packaging
Assembly (Crucial design elements)
- Flexibility versus dedication and changeover versus run-time.
- Development of new packaging concepts.
- Choosing the right presentation and product design that matches standard
platforms. - Optimal order execution for all markets.
Assembly process
- Prototyping
- Small batches
- High volumes
Overall… the R&D costs for API, dosage form formulations, fill and finish
processing, and assembly optimization will indicate the _____________ – a
therapeutically important product can only be brought to market at a
reasonable cost because of the chemical and engineering input in R&D
cost of the final pharmaceutical product
__________: an accidental discovery changed the course of medicine
Penicillin
During World War II, the governments of the United States and the United Kingdom approached the largest U.S. chemical and pharmaceutical companies to enlist them in __________, the
“wonder drug.”
the race to mass produce penicillin
The largest producer of penicillin.
Pfizer
In the discovery of penicillin, _______ upon returning from a long holiday in
September 1928, noted that one petri dish contained colonies of ________ except for clear area contaminated with a fungus that appeared to inhibit bacterial growth.
Fleming; Staphyloccus
In the discovery of penicillin, Fleming identified the contaminant as a strain
of __________ and found that it killed a host of ________ , including those that caused scarlet fever, pneumonia, gonorrhea, meningitis and diphtheria.
Penicillium; Gram-positive bacteria
Year: Alexander Fleming discovered mold could kill germs
1928
Year: Fleming writes an article about
penicillin
1929
Year: Ernst Chain and Howard Florey
began their clinical research
on penicillin after reading Fleming’s article
1937
Year: Penicillin Mice experiments
1940
Year: Penicillin was
tested with humans
1941
Year: US and UK governments worked
together to fund for the first
penicillin drug
1942
Year: The first penicillin plant
opened by Pfizer
1943
Year: Peniciilin was used during
World War II
1944
Year: Charles Pfizer and Charles Erhart founded Charles Pfizer and Company in a red brick building in Brooklyn, NY.
1849
Year: Pfizer chemist James Currie and his assistant, Jasper Kane, successfully pioneer the mass production of citric acid from sugar through mold fermentation - an achievement that eventually frees Pfizer from dependency on European citrus growers.
1919
Year: Doctor Richard Pasternack develops a fermentation-free method for producing ascorbic acid, vitamin C. After building a new plant and initiating a 24-hour-a-day, seven-day-a-week production schedule, Pfizer becomes the world’s leading producer of Vitamin C.
1936
Year: Pfizer succeeds so well in the production of citric acid by fermenting sugar that a pound of citric acid, which had cost $1.25 in 1919, tumbles to 20 cents, and Pfizer is widely recognized as a leader in fermentation technology.
1939
Pfizer responds to an appeal from the United States Government to expedite the manufacture of penicillin to treat Allied soldiers fighting in World War II. Of the companies pursuing mass production of penicillin, Pfizer alone uses fermentation technology.
1941
Using deep-tank fermentation, Pfizer is successful in its efforts to mass-produce penicillin and becomes the world’s largest producer of the “miracle drug”.
1944
Terramycin (oxytetracycline), a broad-spectrum antibiotic that is the result of the Company’s first discovery program, becomes the first pharmaceutical sold in the United States under the Pfizer label. Pfizer begins expansion into overseas markets and the International Division is created.
1950
Pfizer leads the world in developing a vaccine and treatment in response to the COVID-19 pandemic and commits to lightspeed manufacturing to expand vaccine and treatment access to people around the world.
2020-2022
Pfizer perfected _________, an aseptic process for growing large quantities of microorganisms which require oxygen for survival.
deep-tank fermentation
The challenge to the chemical/pharmaceutical engineer is to recognize the
following:
- When a process can just be made larger and therefore be readily
scaled to manufacturing or - When some changes requiring specialized equipment and/or process
operations are needed for successful scale-up and/or economic
operation.
Modern pharmaceutical manufacturing is possible thanks to chemical
engineering techniques and understanding of continuous processing.
-Understanding mass transfer limitations in stirred systems
-Knowing how to work with reacting system optimization
-Control of crystallization processes
-Knowing how to scale-up steps and processes
Processes that involve making
changes to materials as a result
of a chemical reaction.
ØChemical Reactions
ØBiochemical Reactions
UNIT PROCESSES
Processes that involve only
physical changes to materials.
ØSeparation Processes
ØFluid Mechanics
ØHeat and Mass Transfer
UNIT OPERATIONS
Reaction Kinetics in the Industry
- Reactions are complex and rich in chemistry
- Batch processing in majority of operations
Understanding of kinetics allow for:
Process optimization
Process safety evaluation
Understanding of scale sensitivity
Robustness testing
Experimental Approach to
Kinetics Characterization
Calorimetry
Nonmolecule-specific Measurements
In-situ Spectroscopy
