White Paper

FDA’s Quality Management Maturity Program:
Why should CDMOs adhere to the new CDER’s Rating System?

Ensuring the safety and efficacy of pharmaceutical products is paramount in the healthcare industry, making the FDA's Quality Management Maturity (QMM) program and CDER's proposed rating system crucial for Contract Development and Manufacturing Organizations (CDMOs) to adopt. Understanding and adhering to these initiatives can empower CDMOs to ensure high-quality pharmaceuticals, prevent drug shortages, improve regulatory compliance, and build a reputation for reliability and excellence.

White Paper

Bispecific antibodies unleashed

Advances in disease biology have led to the burgeoning development of bispecific antibodies (BsAbs), which are synthetic proteins capable of targeting two discrete epitopes from different antigens. Their bispecific functionality offers promising therapeutic potential such that their applicability to a variety of therapies is being explored. Originally developed for the treatment of cancer, BsAbs may now benefit imaging and diagnostics, as well as disease prevention and treatment. Several bispecific antibodies have already obtained regulatory approval, while hundreds more are in development. In this white paper, we will discuss the predominant formats and mechanisms of action of bispecific antibodies, the most common techniques for BsAbs transient production, and what is involved in their process development. We will also highlight the advantages of partnering with a CDMO with world-class service offerings, from discovery to production, and how doing so can ensure success of your BsAbs by delivering precise immunotherapy solutions and avoiding costly regulatory mistakes.