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Developing & Manufacturing Drugs with HPAPIs

PharmaTech

Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. The degree of potency and specific risks will determine the level of containment needed to ensure operator safety and prevent cross contamination at the development and manufacturing facility.

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Is the pharmaceutical sector realising its potential for sustainable manufacturing?

European Pharmaceutical Review

The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. 1 Every major pharmaceutical manufacturer in the UK and Ireland is investing in making their operations and supply chains more environmentally friendly.

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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

Additionally, the authors highlighted that a greater number of pharmaceutical and biotechnology contract manufacturing organisations (CMOs) has broadened the opportunities for providers of pyrogen testing services. This was attributed to their “highly sensitive and specific” testing capabilities.

Safety 76
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Regeneron's high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups

Fierce Pharma

But the company said it has nothing to do with the drug's efficacy or safety. | In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter.

FDA 246
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AI startup Leucine raises $7m for drug manufacturing digital twin platform

Pharmaceutical Technology

As AI applications in drug manufacturing widen, Leucine’s digital twin of the shop floor helps automate compliance and improve safety.

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Medical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions

European Pharmaceutical Review

It advised manufacturers and study sponsors for these products to “carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA.”

Medical 89
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Nelson Labs facility expansion to benefit parenteral and ophthalmic drug product manufacturers

European Pharmaceutical Review

The investment expands the site to over 30,000ft 2 and includes state-of-the-art instrumentation to provide full CMC support to serve the growth of PODP product customers who require the highest levels of safety, sterility, and stability.