Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Similar biological medicinal products (biosimilars) must demonstrate, during development, similar quality, efficacy and safety to an existing marketed biologic. Biosimilars are just as complex as the reference biologic and as a result comparability studies include a multitude of orthogonal analytical approaches to assess the physico-chemical properties, structure and biological activity. This webinar will cover a summary of the relevant regulatory guidelines and comparability study analytical approaches used to define product identity, integrity, purity. Bioassays to determine potency or a quantitative measure of the product’s biological activity for quality control will also be discussed.
Please fil out the form below to access our On Demand Webinar: Analytical Comparability Studies for Biosimilars.