Pharmaceutical drugs require rigorous laboratory studies and clinical trials before they’re approved for manufacturing. It may take years or even decades before a new drug is approved. Drug development also requires millions or even billions of pounds in investment, from research and development stages to manufacturing and distribution. Safety and efficacy are key issues in making pharmaceutical drugs.
Continue reading to learn more about pharmaceutical manufacturing, including different types of prescription drugs, what sterile pharmaceutical manufacturing is, and why validation is important.
In this post:
What is Pharmaceutical Manufacturing?
Pharmaceutical manufacturing generally refers to the mass production of medicines (oral, injectible or modified release drugs), vitamins, infant formulas, adult food supplements, topical medications, oncological formulations (such as chemotherapy drugs), and vaccines. Molecular biologists, biochemists, pharmacists, and physicians all help in developing various types of pharmaceutical products.
These products are distinct from other types of medical supplies, such as syringes, PPE, surgical instruments, and diagnostic machines like MRI. However, there is some overlap when it comes to manufacturing; some pharmaceutical companies have special divisions that manufacture other types of medical supplies.
The main areas of pharmaceutical manufacturing are the following:
- Medicines for the digestive system: Antacids, antiflatulents, proton pump inhibitors, laxatives, and antispasmodics
- Maintenance and therapeutic drugs for the cardiovascular system: Beta-blockers, diuretics, antiarrhythmics, vasoconstrictors and vasodilators, anticoagulants and haemostatic drugs
- Medications for the nervous system: Psychedelics, hypnotics, anaesthetics, antipsychotics, antidepressants, antiepileptics, barbiturates, antihistamines
- Medicines that aid the immune system: Antibiotics, anti-viral, anti-fungal, anti-inflammatory, anti-allergy
- Endocrine system boosters or suppressants: Androgens, estrogens, gonadotropin, corticosteroids, thyroid hormones
Only a few large pharmaceutical companies have the capacity to manufacture drugs that are fully compliant with the standards and approval process. One of the main reasons why some drugs or brands are more expensive than others is the fact that they undergo such a rigorous process of approval (which is a good thing!).
Types of Pharmaceutical Companies
Pharmaceutical companies are mainly private corporations, but there are also some that are government-owned or controlled companies. Others are joint ventures between private entrepreneurs and the government. They can be classified based on the products that they manufacture and their product volume capacity.
- Mainline pharmaceutical companies: These are the large pharmaceutical companies that have various brands for their products. Well-established companies like Pfizer and Johnson & Johnson employ thousands of scientists in research and development. They have several manufacturing plants worldwide and a wide variety of pharmaceutical and medical supply products, as well as hygiene products.
- Research and development: Some pharmaceutical companies focus on R&D. They help larger companies with their laboratory testing and clinical trials. They mainly serve as subcontractors for large projects. Many large pharmaceutical companies outsource some of their projects to contract manufacturers.
- Generic drug manufacturing companies: Most drugs in the market are patent brands that are exclusive to a few companies. However, branded drugs are expensive, mainly because of the higher cost of development and advertisement. When the patent of these drugs expires, generic pharmaceutical companies can manufacture the drugs, making the cost significantly lower. Generic drug manufacturing companies don’t typically focus on R&D, further reducing the cost.
- AI manufacturers: These companies manufacture a wide range of compound and custom-made biomolecules for drug manufacturers. Many companies are reliant on them in creating vaccines, serums, and other products that require the application of artificial intelligence (AI) in terms of precision and modelling complex molecules.
What Are Prescription Drugs Made Of?
As the name implies, a prescription drug is a drug that needs to be prescribed by a qualified medical practitioner. A prescription is necessary to ensure the safety and appropriateness of the medicine, as well as to avoid drug abuse.
Prescription drugs vary depending on the type of ailments they are intended to cure, meaning their chemical compositions are also widely varied. Aside from antibiotics, the three most commonly used, and oftentimes abused, potentially addictive prescription drugs are classified into three groups:
- Opioids
Opioids are addictive drugs because their molecules attach themselves to the opioids receptors of the central nervous system or CNS. They block pain sensations and promote the feeling of pleasure. While heroin is the most well-known illicit opioid, these drugs are commonly prescribed as pain relievers and for the treatment of coughs. Some examples are oxycodone (OxyContin), hydrocodone (Vicodin), and meperidine (Demerol).
- CNS (central nervous system) depressants
These are used to treat anxiety, panic attacks, and sleep-related disorders like insomnia. They slow brain activities down by increasing the activity of a neurotransmitter known as gamma-aminobutyric acid, or GABA. Taking CNS depressants makes a person drowsy and calm. Some examples are phenobarbital (Luminal), diazepam (Valium), and alprazolam (Xanax).
- Stimulants
Stimulants have the opposite effect of depressants. These drugs stimulate brain activity, resulting in greater alertness and focus. They’re used to treat narcolepsy and ADHD, amongst other things. Examples of stimulants are methylphenidate (Ritalin) and amphetamine/dextroamphetamine (Adderall). Technically, the caffeine in coffee is a stimulant, but only a mild one and obviously isn’t sold as a pharmaceutical drug.
Other types of prescription drugs, like antibiotics, sex hormones, and anti-convulsants are non-addictive. This means that they’re not as prone to abuse and the danger they pose isn’t as great as the mood altering drugs previously mentioned.
What is Sterile Pharmaceutical Manufacturing?
Sterile pharmaceutical manufacturing requires a clean environment free from any microbial contamination. The process is necessary in manufacturing pharmaceutical products that are delivered via the following routes:
- Parenteral: Any non-oral route, typically an injection
- Ophthalmic: The eye route, such as eye drop medicines
- Inhalation: Taken via the nose and lungs
- Otic: Taken via the ears, such as ear drops antibiotics
These routes bypass many of the natural defenses of the body, increasing the risk of infection. Therefore, the products and the delivery system must be completely sterile. The designation includes many complex pharmaceutical products, such as sterile injectables and aerosols.
Safety protocols in clean rooms, such as wearing PPEs and using disinfection chambers, are required by regulations. Two main methods are used to manufacture sterile products:
- Terminal sterilization: This is a process that involves filling and sealing the containers of the products and subjecting them to heat or irradiation
- Aseptic manufacturing and sterile fill-finish: This process involves the separate sterilization of a drug product, container, and closure. The process must be done in a clean room or high-quality environment
What is Non Sterile Pharmaceutical Manufacturing?
Many types of pharmaceutical products aren’t required by regulations to be sterile. These usually include topical products, such as creams and gels. Although clean rooms and sterilization processes aren’t required, manufacturers must follow hygienic standards. The microbiological quality of the products must be maintained at certain levels, and inspections are conducted to ensure that pathogens, such as Salmonella sp, Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa, are not present.
Why is Validation Important in Pharmaceutical Manufacturing?
Validation is about quality control. It’s crucial in pharmaceutical manufacturing to ensure that the processes involved will have consistent and repeatable results. Given a certain set of specifications or formulations, precise results are expected in terms of formulations and quality of products.
Validation requires testing samples of product batches. For instance, the weight of each medicine capsule must be precisely calibrated based on the active ingredients. The machines must be able to produce consistent results despite the complexity of the processes. Therefore, validation is mainly applied to quantifying and qualifying machines and equipment.
