Therapeutic biological products and biosimilars have to strictly comply with the legal and regulatory requirements of local regulatory agencies responsible for premarket review and oversight. Pharmaceutical and biotechnology companies need to make sure their biological products (e.g., therapeutic antibodies and proteins) with high productivity, purity, safety, potency, and other good characteristics with reduced cost in the development process. Meanwhile, the Current Good Manufacturing Practice (cGMP), the formal regulations of the Food and Drug Administration (FDA) also render companies cautious in designing, monitoring, controlling, and maintaining the manufacturing processes and facilities.

In this material, we share some upstream and downstream information for biological product manufacture and development, a portion of which are shown below:

1. Necessary Cell Line Development and Characterization Strategies for Biopharmaceuticals Production
2. A cGMP-Compliant Cell Banking System
3. Solutions to Product Formulation and Purification
4. Analytical Methods and Bioassay Quality Control
5. Outlook and Suite for cGMP Manufacturing