Chemical engineers design machineries, equipment, and instruments for manufacturing chemical products. The pharmaceutical industry is part of the chemical manufacturing sector, with one key distinction: the focus is on manufacturing medicines and other medical products.
Chemical engineers in the pharmaceutical industry are essential in ensuring the accuracy, precision, efficiency, quality, and safety of the manufacturing processes.
In this post:
What is Chemical Engineering in the Pharmaceutical Industry?
The pharmaceutical industry requires a high level of precision in its mass production of medicine. Machines must be properly calibrated and tested for efficiency and accuracy. Otherwise, the medicines that pharmaceutical companies produce would either be unsafe or ineffective. A few milligrams off the needed dosage, and medicines could become useless or life threatening.
This is why chemical engineers are needed in the pharmaceutical industry. Mass-producing medicines involves complex and meticulous processes at the multiple stages of production. By applying their advanced knowledge of chemistry, biology, physics, and maths, chemical engineers are able to optimise these pharmaceutical processes so that they’re safe, accurate, and effective.
Before medicines are mass-produced, they undergo several stages of testing and government approval. Chemical engineering has a role to play in each of these stages.
Discovery and development
The first life stage of every new drug is discovery and development in a lab. At this stage, the focus is on scientific study in two key areas:
- Discovery, or target identification: A specific biochemical mechanism, or drug target that’s related to a particular disease process is chosen as a basis for the new drug
- Development: Several drug candidates are researched, developed, and tested on how they interact with the drug target. This involves a rigorous screening process
One of the major support organisations for this stage is the Engineering and Physical Sciences Research Council (EPSRC), which offers research grants that cover healthcare technologies and other engineering research works related to manufacturing.
Individual researchers or owners of pharmaceutical research laboratories can apply for financial grants and technical assistance from EPSRC. The institution has four centres that can help develop medicines through collaboration and networking, feasibility studies, and technical support for the research and development projects.
Here, the chosen drug candidate is characterised in terms of its molecule size, shape, ideal conditions, toxicity, bioactivity, and bioavailability. The main goal here is to determine the drug candidate’s mechanism of action.
Development and translation
After it’s been characterised and approved, the drug is synthesised into a medicine and tested in a laboratory. During this, drug developers must create a formulation that’s in keeping with the proper drug delivery parameters. The stability of the drug is also tested here, including under certain storage conditions that could affect or change it – such as light or heat.
One of the organisations that can help pharmaceutical researchers at this stage is Catapult, which has a specialty in cell and gene therapy, as well as precision medicine. It can provide assistance in translating a newly developed medicine into a commercially viable product.
Preclinical testing, clinical trials, and regulatory assessment
Before the new medicine can be mass produced, it must undergo various tests and trials. At this stage, the new product is subjected to stringent testing and clinical studies, and is scrutinised by regulatory bodies to ensure compliance with standards.
Preclinical testing is concerned with analysing the medicine’s bioactivity, safety, and efficacy. There is a big focus on toxicology at this stage, with the following tests getting carried out:
- Acute studies
- Repeated dose studies
- Genetic toxicity studies
- Reproductive toxicity studies
- Carcinogenicity studies
- Toxicokinetic studies
Tests conducted during the preclinical stage of development are crucial in supporting the clinical trials, which come next. There are three main phases of clinical trials:
- Human Pharmacology, where initial single-dose studies, dose escalation, and short-term repeated-dose studies are tested on healthy volunteers
- Therapeutic Exploratory, where the medicine’s efficacy and side-effect profile is analysed in the patients
- Therapeutic Confirmatory, where large patient populations are used to test the overall safety and efficacy of the medicine. Clinical trials in this phase are large-scale
The most relevant agency that will be involved in this stage is the Medicines and Healthcare Products Regulatory Agency (MHRA). This is the agency that regulates all medicines and medical devices in the UK, assessing the benefits versus the risks.
What is the Role of a Chemical Engineer in the Pharmaceutical Industry?
Chemical engineers are involved in all of the various stages of pharmaceutical product development. They’re responsible for ensuring that the large-scale production, packaging, and delivery of pharmaceutical goods, especially medicines, are done correctly.
A chemical engineer in the pharmaceutical industry does this by designing, implementing, controlling, and optimising the pharmaceutical processes carried out at every stage of development. For example, chemical engineers in this sector often design new processes and equipment that will innovate the current processes. Similarly, they’re used to modify any existing pharmaceutical equipment or processes.
Chemical engineers find ways to optimise pharmaceutical production through:
- Designing chemical routes: A chemical engineer designs processes that ensure product consistency and purity through precise delivery of the chemical raw materials
- Scaling up production: It’s the chemical engineers job to develop a process that moves a product from small scale to large scale production in a way that’s efficient, and maintains the integrity of the medicine
- Improving the efficiency of processes for existing products: While new machines, technology, and process routes can be developed, this can be expensive and time consuming, so chemical engineers often focus on optimising pharmaceutical facilities and processes that are already in place
At every stage of pharmaceutical production, chemical engineers must consider how they can improve or at least maintain the high standards of efficiency, consistency, and safety. The core of high quality and dependable pharmaceutical products is ensuring consistent active pharmaceutical ingredients, or APIs. Medicine dosage must also be accurate and precise, and chemical engineers collaborate with quality control teams to ensure this.
In the pharmaceutical sector, chemical engineers apply their understanding of chemical kinetics and chemical properties in ensuring efficient designs. The main goal is maximum efficiency.
However, chemical engineers inevitably face various constraints when designing large-scale processes for the mass production of medicines. These constraints are mainly based on the physical limitations of machines, the available manufacturing space, the chemical properties of ingredients, budgetary considerations, and the environmental impact of the machines or processes being designed.
Pharmaceutical Engineering vs. Chemical Engineering
Pharmaceutical engineering can be considered a branch of chemical engineering. It’s a sub specialisation that specifically focuses on the production of medicines and other pharmaceutical products.
Chemical engineering, on the other hand, is about designing manufacturing processes, machines, and equipment for various industries, like industrial plants and refineries. While you get chemical engineers in the pharmaceutical industry, chemical engineering isn’t focused on pharmaceuticals specifically.
Meanwhile, pharmaceutical engineering is concerned with devising chemical processes or routes to ensure the quality, safety, and purity of APIs. Pharmaceutical engineers design and set up the machines and equipment for the mass production of medicines. They also help in researching and developing drugs.
Both chemical engineers and pharmaceutical engineers are responsible for ensuring safety, quality, efficiency, and cost-effectiveness of the products at various stages of pharmaceutical production. They’re both involved in the following:
- Product conceptualisation and research
- Product design and development
- Scale up of production capabilities
- Product manufacturing
- Product testing and legal compliance
- Product manufacturing, packaging and labelling
All content published on the ReAgent.ie blog is for information only. The blog, its authors, and affiliates cannot be held responsible for any accident, injury or damage caused in part or directly from using the information provided. Additionally, we do not recommend using any chemical without reading the Material Safety Data Sheet (MSDS), which can be obtained from the manufacturer. You should also follow any safety advice and precautions listed on the product label. If you have health and safety related questions, visit HSE.gov.uk.