Biologic drugs are manufactured in living systems or extracted from biologic sources. As the understanding of the molecular and genetic bases of disease increase, biologics often make use of new technologies to harness scientific progress – monoclonal antibodies, antisense therapies or recombinant fusion proteins.
Most biologics are complex molecular entities, difficult to fully characterize by existing science. This is why biologic products are often characterized by their manufacturing processes, which are likewise complex and very sensitive to changes. Slight changes in manufacturing conditions may induce potential changes in the biologic drug quality attributes with potential effect on safety and efficacy in patients. Hence, solid analytical tools, and thorough comparability assessment that may include further clinical testing are often required to demonstrate safety, purity and potency throughout development.
Upstream and Downstream process development along with Bioassays are the foundation by which analytical control strategies for biologics are built, and are required throughout biologics development, from research to final product. While the FDA and ICH regulatory guidelines provide a necessary framework for biotechnology product development and analytical testing, practical regulatory and operations experience is imperative to successfully navigate through the regulatory maze to the market.
Where are you at with your process and controls? Who is managing the upstream and downstream operations? What bioassays are necessary for your product? When, where and how to validate your bioassay? We encourage you to Ask our Experts .
DSI provides high quality and customized expertise related to industry standards and FDA, EMA, and ICH regulations as these apply to the research, development and commercial production of biologic therapeutics and related technologies.
Our biologics team here at DSI guide biotechnology and pharmaceutical companies to analyze, determine and implement the most timely and efficient CMC and bioanalytical strategies to steer a molecule from discovery throughout development, and meet the regulatory requirements necessary to obtain marketing approval on the worldwide market.
The services include a wide range of regulatory, CMC, and bioassay development support for product characterization, batch release testing, preclinical and clinical testing, regulatory submissions and post-marketing compliance.
Our team at DSI helps you get your biologic to market on time and keep it there