The rapidly growing numbers of monoclonal antibodies (mAbs), fusion proteins and biosimilars produced by the pharma industry have greatly improved patient care and resulted in a proliferation of innovative treatment options. To date, there are over 100 biosimilars [1, 2], 162 mAbs [3] and over 11 fusion proteins [4] approved for therapeutic use. These new therapeutic proteins are often more...
Articles
The benefits of CDMOs with customer-centric approaches and cohesive teams
In the highly competitive and rapidly evolving biopharma industry, choosing the right contract development and manufacturing organization (CDMO) is a critical decision that can significantly impact the success of a pharmaceutical development journey. When exploring potential CDMO partners, two key factors to consider are whether the company has a customer-centric approach, and if the team itself...
How enhancing equipment reliability supports quality, efficiency, and operational excellence
Importance of equipment reliability Successfully manufacturing a drug product requires people, proper equipment, and materials. It’s the classic three-legged stool analogy. Even with well-trained staff and high-quality materials, if the equipment does not function as expected, or is not reliable, the final product can never be cost-effectively produced. Product quality will likely be compromised...
Solving Controlled Release Drug Delivery Challenges Using Extrusion-Spheronization
Extrusion Spheronization’s Expanding Influence as a Drug Manufacturing Driver Widely acknowledged as a predictable vehicle for the control, distribution and transportation of therapeutic agents around the body, E-S engineered formulations make a variety of common and emerging controlled release dose forms possible. These include fixed-dose combinations (FDCs), combined, modified release...