GMP-Creative Biolabs provides one-stop customer-oriented services including biopharmaceutical contract R&D, process development, cGMP manufacturing, QA & QC solutions for scientific research, preclinical, clinical and commercial supply. We proceed your projects according to your specific demands in quality, timeline and budget, supporting researchers across different therapeutic areas. Clear, open and regular communication with customers is as important to our success as our in-depth scientific knowledge. more
Biosimilars are defined as biotech products that have been demonstrated to have comparable purity, safety, and efficacy to the reference medicine. At present, there is an increasing interest in biosimilar products from the biopharmaceutical industry. Major developments have occurred in regard to establishing a regulatory pathway for approval of these novel medicines and in scientists understanding of how different quality attributes of a biosimilar affect its safety and potency. Before approving a biosimilar, experts in the Food and Drug Administration (FDA) must evaluate its quality rigorously and conclude that there are no clinically meaningful differences between the biosimilar and the original (already approved drug). Here, Creative Biolabs is a famous biotech service provider that has won high reputations for accomplishing a variety of challenging projects of drug development, including biosimilars.
Fig.1 Biosimilars: shorter path to approval.
Hormones are a class of signaling molecules produced by glands of multicellular organisms and secreted directly into the blood. They are chemical messengers responsible for the communication between organs and tissues and could be transported by circulatory systems to target distant organs for physiological regulations and behavioral activities, including metabolism, respiration, digestion, mood, movement, reproduction, and so on. Hormones affect distant organs by binding to the specific receptor on targets and thus resulting in a change in cell functions. The secretion of hormones occurs in response to particular biochemical signals from a range of regulatory systems. The messengers are created by numerous tissues, and endocrine glands (e.g. hypothalamus, thyroid, thymus, pancreas, ovaries, and testes.) are a cardinal example, also by specialized cells of many other organs.
Fig.2 Milestones of follicle stimulating hormone compounds production. CHO: Chinese hamster ovary; FSH: Follicle stimulating hormone; IVF: In vitro fertilization. (Santi, 2014)
Compared to conventional medicines, biosimilars cannot be made by following a chemical ingredient. Because biosimilars derive from living organisms, they are relatively variable in nature as well as their structures are complex and not easy to characterize. Generally, developing biosimilars is a far more difficult process than that of generic drugs. Biosimilars belong to biopharmaceuticals that only should be used for follow-on biologics approved under a defined regulatory agency. The primary rationale for the treatment with biosimilars is cost-saving. Regulatory requirements, global harmonization and standardization strategies for biosimilar products are evolving that facilitate their widespread applications in the clinic. As we know, Creative Biolabs is a professional institute in biotech services and always devoted to assisting in potential medication developmental projects. We can make use of stable cell lines, such as CHO cells, to offer one-stop, customized services for the development and production of hormone biosimilars.
To discuss your Hormone Biosimilar Stable Cell Lines demands or to request a proposal, please contact us by