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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.

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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. What is driving the surge in demand for APIs?

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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.

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Athersys to Host a Virtual Investor Day

The Pharma Data

Some of the more significant known risks that we face are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues.

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Advancements in Automation of Processes: Key Value Driver for Escalated Interest in Cell Therapies Manufacturing Domain

Roots Analysis

Efforts to introduce automation technologies in cell therapies manufacturing are underway, and if implemented successfully, can significantly help in the elimination of human intervention and reduce the risk of contamination.