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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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A winning combination: The benefits of micronization and containment in a single installation

Pharmaceutical Technology

The number of high-potency drug approvals has increased over the last decade, driven by the increasing use of APIs (Active Pharmaceutical Ingredients) in the pipeline and among marketed drugs. Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination.

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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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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 suggests a move towards high-value specialised manufacturing. Containment challenges.

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Outsourcing Biologics Fill Finish Manufacturing : Streamlining the Production Process for Biopharmaceutical Companies

Roots Analysis

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

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HPAPIs – Current Interest of the Pharmaceutical Industry

Roots Analysis

As the global market for pharmaceutical solutions is increasing, pressure to bring biological APIs in different biological forms is rising and with the rising demand of targeted therapies, antibody-drug conjugates (ADCs) and cytotoxic drugs have gained wide attention in the field of HPAPIs.

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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.