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Chemical synthesis: containment challenges for HPAPI handling

Pharmaceutical Technology

This process is used to manufacture pharmaceutical products with low molecular weights in large batches within a short timescale. While this is exciting news for the pharmaceutical industry, chemical synthesis presents a number of challenges when it comes to running a manufacturing plant. Chemical synthesis solutions. Free Webinar.

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Gilead, having resolved manufacturing issues, forges ahead with HIV drug

Bio Pharma Dive

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

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Resolving challenges with product recovery in biopharma manufacturing

Pharmaceutical Technology

Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. Yet this is far from straightforward.

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Understanding the rules on HPAPI containment in high potent manufacturing

Pharmaceutical Technology

How to ensure safety and quality in pharmaceutical facilities when using HPAPIs in drug development. Read more here.

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What’s next for Container Closure Integrity Testing?

Pharmaceutical Technology

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Many test methods have thus been developed.

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How API CMOs can improve containment capabilities without facility acquisition

Pharmaceutical Technology

According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities. Flexible containment solutions for potent APIs. Partnering with containment experts.

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The rising importance of containment in small molecule drug development

Pharmaceutical Technology

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. Manufacturing these highly potent and often cytotoxic drugs introduces many risks for operators and the environment. But containment is not only important at commercial-stage manufacturing.