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API landscape in 2022: Drivers and solutions for small molecules

Pharmaceutical Technology

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. This adds costs and time to the processes involved.

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HPAPIs – Current Interest of the Pharmaceutical Industry

Roots Analysis

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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Optimizing lyophilization cycle times and improving stability for complex injectables 

Pharmaceutical Technology

Research Associate III, who is a parenteral fill/finish and lyophilization specialist at Baxter BioPharma Solutions (BPS) – a business unit of Baxter Healthcare, Inc. Why is continuing research so important? Pharmaceutical Technology spoke with Kevin Bond Ph.D., What are the key advantages of this stabilization method?

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The rising importance of containment in small molecule drug development

Pharmaceutical Technology

Manufacturing these highly potent and often cytotoxic drugs introduces many risks for operators and the environment. Cross-contamination of standard products with highly potent ones is another key concern. Many companies are now prioritising investments in containment systems, GlobalData research shows.

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FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

The letter also stated that the company’s response to the inspection report was “inadequate because it did not include a review of environmental monitoring data in your manufacturing areas, an adequate risk analysis of previously manufactured drug product, or testing of reserve samples from impacted batches.” Dextrum Laboratories Inc.

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RRx-001: Jack of all trades, master of…many

Drug Discovery World

So extreme and so complex are the special safety and handling measures required during the manufacture of RRx-001 that only a handful of highly specialised contract manufacturing organisations (CMOs) in the world possess the necessary qualifications, expertise, and experience to make and store it.

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

billion, primarily driven by Pfizer CentreOne, Pfizer’s contract manufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., Clinical and Research Developments. Current 2021 financial guidance is presented below. . . down 7%, which reflects relatively stable U.S.