Articles

Enzyme experience key to commercializing novel  blood diagnostic device

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™...

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How roller compaction helps dry powder formulations go with the flow

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...

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Why it can take so long to validate pharmaceutical manufacturing processes during site-to-site technology transfers and what can be done to speed it up

Why it can take so long to validate pharmaceutical manufacturing processes during site-to-site technology transfers and what can be done to speed it up

Process validation too slow? Here’s how to speed things up Technology transfers and process validation are an integral part of drug development and commercial drug product manufacturing. Successful technology transfer from site-to-site requires careful evaluation of manufacturing requirements and consequently applying that wisdom to validate a robust process that supports commercial-scale...

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Supply chain disruptions and their impact on quality and operations

Supply chain disruptions and their impact on quality and operations

COVID-19’s impact on global supply chains as well as tectonic geopolitical shifts have resulted in considerable disruption, particularly to the contract development and manufacturing organization (CDMO) industry. Looking back, what is troubling about the supply chain challenges CDMOs faced during the past three years is that they were very similar to the issues plaguing many pharma manufacturers...

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