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...
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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...
Enzyme experience key to commercializing novel blood diagnostic device
Cell line development insight boosts active protein productivity more than five times Q-Sera, an internationally recognized biotech innovator engaged Bora’s team to develop and manufacture an innovative active protein, RAPClot™ (ecarin), a key component of its proprietary coating to improve the function of a serum-based blood testing device. Blood collection tubes are coated with RAPClot™...
How roller compaction helps dry powder formulations go with the flow
Importance of good flow Good powder flow is particularly important when manufacturing tablets and capsules because rapid and accurate filling of the tablet die or capsule body is essential to achieve consistent weights, and thus, a consistent drug dose. When powdered active pharmaceutical ingredients (API) possess poor flow characteristics, they present a handling challenge during the...