Emergent

When developing a new drug product, quality, safety and timing are critical. A Contract Development and Manufacturing Organization (CDMO) can be a valuable partner to help mitigate risks, avoid missteps and control costs in the process. But the success of the partnership revolves around a key step: the technology transfer.

As more biologics move through research and development, the demand for specialized aseptic fill/finish services has steadily climbed. Aseptic processing with the highest degree of sterility assurance, filling accuracy and quality is critical for high-value, small-batch therapies. Anything less impacts regulatory compliance, project timelines and—most importantly—patient safety. This white paper explores the specialized equipment, expertise, and services needed for efficient biologics fill/finish manufacturing.

Technical proficiency in downstream processes is critical for successful drug substance manufacturing. Utilizing a CDMO’s experience and expertise in developing appropriate processes for your molecule can help achieve program goals.

Lipid-based formulations are gaining global awareness, notably with lipid nanoparticles (LNPs) being a key component in several current COVID-19 and mRNA vaccines. Lipid-based formulations, including liposomes and LNPs, are an effective drug delivery system for a variety of active pharmaceutical ingredients (APIs), notably for complex parenteral drug products including cancer, viral, and gene therapeutics. In this podcast, we discuss how Emergent has been involved in the manufacturing of lipid-based formulations over the past two decades, along with factors to consider when partnering with a CDMO for lipid-based formulation manufacturing.