Biopharmaceuticals are a cutting-edge segment of pharmaceutical development, different to other medications for a variety of reasons.
What are biologics?
Traditional medications are synthesized through chemical reactions, whereas biologics are derived from and reproduced, at least partially, from living organisms. For instance, blood and plasma transfusions, which are derived from humans, and skin grafts are biologic treatments.
Insulin, a diabetes treatment, is also a biologic. It was first sourced from cows and pigs, but scientists frequently produce biologics using gene-edited microbes in contemporary practice.
The definition of biologics is also somewhat flexible. For example, mRNA therapeutics are synthetically created but are classified as biologics by the FDA.
New types of treatment
Biologics can treat conditions that traditional medicines cannot, and because they have larger molecular structures, they often target diseases more specifically than traditional medications.
One crucial example is exagamglogene autotemcel (Exa-cel), a treatment for sickle cell disease and beta thalassemia that treats the underlying disease rather than merely alleviating symptoms.
Another potentially curative approach for sickle cell disease, allogenic hematopoietic stem cell transplantation, is also biologic. However, the method is limited by the necessity for a compatible donor.
In contrast, Exa-cel is a one-time treatment that involves extracting a patient’s blood-forming stem cells, editing them to produce healthy hemoglobin, and subsequently reintroducing them into the patient’s body. This treatment has been shown to improve blood markers, enhance quality of life, and provide a potential cure for the disease.
Another category of biologics includes immunosuppressants, such as disease-modifying antirheumatic drugs (DMARDs), which can be either traditional or biological. DMARDs are employed to treat conditions including rheumatoid arthritis and various cancers.
When managing these conditions, healthcare providers must consider the balance between side effects and resistance, highlighting the importance of having a diverse array of treatment options.
Traditional DMARDs are typically administered first, with biologics often prescribed after the failure of traditional therapies or in conjunction with them. All DMARDs carry potential side effects, such as an increased risk of infection, but biologic DMARDs have been seen to present more severe adverse effects.
How are biologics used?
Biologics are employed to treat a broad spectrum of conditions, including those previously mentioned, such as arthritis and blood disorders.
Lifileucel, for example, is a biologic used to treat melanoma that is particularly effective for patients with treatment-resistant disease. This therapy is derived from a patient’s T-cells, but unlike older methods that used T-cells obtained from a patient’s circulating blood, Lifileucel instead employs cells extracted from the patient’s tumor.
These cells leverage the capabilities of the patient’s own immune cells, which are then multiplied for enhanced effectiveness.
Other biologics, such as monoclonal antibodies, are also employed in the treatment of asthma, providing a more targeted approach than conventional steroid therapies and improving quality of life. Additionally, biologics play a crucial role in vaccine development.
Industry development
Manufacturers are also advancing the development of ‘biosimilar products,’ which demonstrate no clinical differences from the reference biologic. An ‘interchangeable biosimilar product’ indicates that patients experience no change when transitioning between the biologic and the biosimilar, enhancing the affordability of biologics for patients.
Challenges associated with biologics
Though biologics offer unprecedented opportunities, their development process is both complex and costly. Scaling up production is difficult, since biologics require living systems for manufacturing. Additionally, they are typically larger, more complex molecules than traditional drugs.
Reproducibility poses further challenges, as minor variations in the medication may arise from the organisms used in production. Rigorous quality control procedures are implemented to address these variations, further increasing costs. Consequently, the complexities involved in developing biologics often render them more expensive than chemically synthesized medications.
Additionally, biologics present a higher risk of immune responses and allergic reactions in patients. However, researchers are exploring strategies to mitigate these risks, such as encapsulating biologics in liposomes or lipid nanoparticles (LNPs).
Depiction of a liposome, which can be used to encapsulate a biologic. Image Credit: Genizer
Patients may also have concerns regarding the injection and infusion methods commonly employed for biological therapies.
The future of biologics
Although the development of biological medications can be challenging, they have been instrumental in treating and curing conditions that would otherwise be unmanageable. The potential for innovation in this field is remarkable, and Genizer is eager to witness future advancements.
References and further reading
- American Cancer Society Cancer Action Network. (2018). Understanding Biologic and Biosimilar Drugs. (online) Available at: https://www.fightcancer.org/policy-resources/understanding-biologic-and-biosimilar-drugs.
- Clinic, C. (2024). Biologics (Biologic Medicine). (online) Cleveland Clinic. Available at: https://my.clevelandclinic.org/health/treatments/biologics-biologic-medicine.
- Benjamin, O., Goyal, A. and Lappin, S.L. (2022). Disease Modifying Anti-Rheumatic Drugs (DMARD). (online) PubMed. Available at: https://www.ncbi.nlm.nih.gov/books/NBK507863/.
- Phillips, C. (2024). Lifileucel First Cellular Therapy Approved for Cancer - NCI. (online) National Cancer Institute. Available at: https://www.cancer.gov/news-events/cancer-currents-blog/2024/fda-amtagvi-til-therapy-melanoma.
- Frangoul, H., et al. (2024). Exagamglogene Autotemcel for Severe Sickle Cell Disease. New England Journal of medicine/The New England Journal of Medicine, (online) 390(18). https://doi.org/10.1056/nejmoa2309676.
- Hematology. (2025). Gene Therapy Improves Quality of Life for SCD, Beta Thalassemia - Hematology. (online) Available at: https://www.hematology.org/newsroom/press-releases/2025/gene-therapy-leads-to-improved-quality-of-life.
- Kardas, G., et al. (2022). Monoclonal antibodies in the management of asthma: Dead ends, current status and future perspectives. Frontiers in Immunology, (online) 13, p.983852. https://doi.org/10.3389/fimmu.2022.983852.
About Genizer
Genizer™, located in Technology Link in Greater Los Angeles, is dedicated to advancing homogenizer nanotechnology.
The company provides high-pressure homogenizers, liposome extruders, sanitary heat exchangers, diamond interaction chambers, and high-pressure gauges compatible with other brands of high-pressure homogenizers, pumps, and microfluidizers.
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