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, also known as follow-on biologics (or biopharmaceuticals), play an important role in pharmaceutical market. However, since it is hard to ascertain the original clone, cell bank, exact fermentation and purification process, or the active drug substance of the drug, follow-on manufacture faces lots of challenges. Creative Biolabs is an undisputed global service provider in CGMP manufacture of biologics, provideing one-stop, full cGMP services in collaboration with downstream cGMP partners.
It is well known that biologics or biopharmaceuticals have emerged as a highly-effective class of medicines that are produced from living cells through the biological process. A biosimilar, also known as similar biological product or follow-up biologic, is a biological medicinal product which has highly similar to the reference product notwithstanding minor differences in clinically inactive components. By minor differences, the FDA agency states that there should be no clinically significant differences between the biosimilar and the reference biologic in terms of the safety, purity, and potency of the product. High-quality, reliably supplied biosimilars can offer additional therapeutic choices to patients at affordable prices, simultaneously, generating significant savings for healthcare systems; moreover, continuing development of biosimilars can increased commercial competition and create numerous opportunities for lots of biopharmaceutical companies to enrich their drug list and expend their market.
Advantages of biosimilar stable cell lines:
• Rapid screening and condition testing
• High productivity and purity
• Easier genetic engineering
• Complete condition control
• Short production time
• No animals required
Creative Biolabs has developed a range of stable cell lines using our proprietary gene screening and amplification system. These manufacturing cell lines have been accepted by CMO’s and manufacturers worldwide to produce cGMP material. The high productivity and stable quality parameters of our cell lines equal security. Customers save time and reduce the risks involved in developing and producing biosimilars. There are various biologics including antibodies, recombinant proteins etc. that have been proved by FDA or EMA. As several drugs fell off patent every year, Creative Biolabs will provide professional services to fasten your biosimilar development in the first place.
For R&D use only, not directly for clinical use.