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 biologics that have high similarity to their reference products, in spite of minor differences in clinically inactive components. As specially approved, imitation drugs, biosimilars are structurally similar to the original and their actions are identical to the original on pharmacological effects. In contrast to most chemically synthesized drugs, biosimilars have a great molecular weight and a highly complex molecular structure. The tertiary and quaternary structure may be heterogeneous, even if there is an identical amino acid sequence among them. Obviously, biosimilars must be managed differently from the copies of generic drugs. Hence, there is an agreement between the regulatory measures of the FDA (Food and Drug Administration) and the EMA (European medicines agency) regarding evaluating preclinical data. However, the FDA requires clear factual information of clinical results for bioequivalence, while for the EMA, the evidence of pharmacodynamic and pharmacokinetic equivalence is sufficient.
Fig.1 Stepwise development of a biosimilar. (PK: Pharmacokinetic, PD: pharmacodynamic). (Li, 2015)
Enzymes are catalysts for chemical reactions in the metabolism of all organisms and play a critical part in the regulation of cellular metabolic processes, as drug targets, and in a variety of biotechnological applications. They represent the largest and most diverse group of proteins and can be classified into several classes, including oxidoreductases, hydrolases, lyases, ligases, and transferases. Enzymes as drugs have two key characteristics, leading to the development of many enzyme drugs for a broad range of disorders. Firstly, enzymes usually bind to and act on their targets with high affinity and specificity. Secondly, enzymes are catalytic that convert multiple molecules to desired products. These features make enzymes potent drugs and can accomplish therapeutic biochemistry that small molecules cannot in the body.
Fig.2 Therapeutic enzymes are used in the treatment of a variety of disorders and diseases. (Vellard, 2003)
The widespread use and patent expiration of numerous biologics resulted in global interest in the development of biosimilar. These kinds of products offer more novel treatment options for patients, potentially reducing medical costs and increasing access to lifesaving medications. The FDA has approved commercial biosimilars to treat situations, involving cancer, rheumatoid arthritis, Crohn’s disease, irritable bowel syndrome, psoriasis and so like. Notably, the manufacture of biosimilars is a complex process referring to living systems, thus the development of a biosimilar is more rigorous than that of a generic small-molecule drug. Creative Biolabs has established a series of stable cell lines, such as CHO (Chinese hamster ovary) cells, for the research and development of enzyme biosimilars. We are able to provide one-stop, customized services for clients to achieve their goals and have rich experience in drug development to ensure the efficacy and safety of biosimilar products.
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For R&D use only, not directly for clinical use.