Risk and Lifecycle Management for Biopharma Operations

By working with the best biopharmaceutical companies for over a decade, 4Tune Engineering (4TE) has built a portfolio of services that enables companies to address
current-century challenges. The biotechnology industry needs to address advanced therapies and personalized medicines and deliver explicit patient outcomes. Biologics today fall into four categories: monoclonal antibodies (MAbs), biosimilars, advanced therapeutic medicinal products (ATMPs), and cell and gene therapies (CGTs). Consequently, we can ask whether our manufacturing science and technology (MSAT) approaches are up to the challenge of covering all those different types of product.

The following Special Report details 4TE’s strategies for applying the US Food and Drug Administration’s totality-of-evidence approach for risk-based biologic development. Fill out the form below to read the full report now.