Biologics
Biologics are commonly developed by pharmaceutical companies to sell in the field of medicine. Physicians prescribe these medications to prevent, control, cure, and modify disease progression.
Biologics “are pharmaceutical compounds synthesized or extracted from a biological source often with highly complex structures.” The fact that these products often arise from living organisms allow then to induce allergic reactions and other side effects when used. For this reason, they must be closely monitored as they enter the market. This also contributes to the high cost of development associated with these drugs. The most well-known FDA approval of biologics is Humulin, or human insulin, in 1982 using a DNA-recombinant protein.
The expanding market for biologics, despite their associated clinical risks, means they have emerged in “many disease areas, notably oncology, inflammation/autoimmunity, and cardiovascular-metabolic medicine.” Some examples include, but are not limited to “diabetes, cancer, chronic kidney disease, rheumatoid arthritis, psoriasis, blood disorders, vaccines and inflammatory bowel diseases.” Biologics could also be used in the clinical setting of psychiatry.
Biologics are used to alter disease progression. When successful they can aid in the maintaining the human body’s homeostatic processes. Notable risks of biologics are the allergic reactions and autoimmune reactions that can be induced. However, by ensuring their safe entry to the pharmaceutical market their benefits can outweigh their risks.
MicroBio works to ensure the safety of biologics under ISO 13022:2012 (Medical products containing viable human cells — Application of risk management and requirements for processing practices) and ISO 18362:2016 (Manufacture of cell-based health care products — Control of microbial risks during processing). These standards both work to ensure that any “medical product,” namely biologics and medical devices, have sufficient benefits that outweigh patient risks. ISO 13022:2012 specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products, biologics, medical devices and active implantable medical devices, or combinations thereof. It covers viable human materials of autologous as well as allogeneic human origin, obtained from living or deceased donors. Meanwhile, ISO 18362:2016 specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled 'sterile' and to CBHPs not labelled 'sterile'. For more information on these standards and MicroBio Consulting’s process for biologic certification please contact us by phone at 763-639-7111 or by email at info@micrbioconsulting.com.
Resources referenced:
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Chan, J., & Chan, A. (2017). Biologics and biosimilars: what, why and how?. ESMO Open, 2(1), e000180. https://doi.org/10.1136/esmoopen-2017-000180
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Modell, H., Cliff, W., Michael, J., McFarland, J., Wenderoth, M. P., & Wright, A. (2015). A physiologist's view of homeostasis. Advances in physiology education, 39(4), 259–266. https://doi.org/10.1152/advan.00107.2015