Biosimilars
Overview
Biosimilars
As the number of biologics going off-patent increases biosimilar medicines become increasingly appealing to healthcare organizations, physicians, and patients by offering greater choice and a more cost-effective option.
The development of biosimilar medicines involves rigorous analytical studies to thoroughly understand their similarity to the reference product. Toxicity assessments and clinical studies are also conducted to further confirm this similarity. The ultimate goal is to demonstrate that, based on these findings, there are no clinically meaningful differences between the reference product and the biosimilar.
Biosimilar Development Services
At GNG, we provide comprehensive biosimilar development services, guiding you through the intricate process of bringing a high-quality biosimilar to market. Our expertise ensures your biosimilar meets all regulatory requirements and matches the safety and efficacy of the reference product.
Reference Product Analysis
We start by selecting and thoroughly analyzing the reference biologic product. Our advanced analytical techniques ensure a detailed structural and functional comparison.
Cell Line Development
We assist you in choosing the optimal expression system, conducting engineering, and selecting the best cell clones to maximize biosimilar production and quality.
Process Development
Our team optimizes both upstream and downstream processes. This includes refining cell culture conditions and developing efficient purification methods to ensure high yield and purity.
Analytical Characterization
We conduct extensive physicochemical and biological characterizations to ensure your biosimilar closely matches the reference product in structure and function. Immunogenicity assessments are also performed to predict and evaluate potential immune responses.
Pre-Clinical Studies
We provide support of in vitro and in vivo studies to compare the activity, pharmacokinetics, pharmacodynamics, and toxicity of the biosimilar with the reference product.
Unlock Value with Flexible
Partnership Structures
We specialize in developing biosimilar cell lines and process know-how. By independently creating and owning all assets, we provide a range of partnership structures tailored to your needs. Contact us to accelerate your biosimilar development process efficiently.
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