Pharmaceutical Technology
SEPTEMBER 15, 2022
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.
Roots Analysis
APRIL 15, 2024
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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Roots Analysis
OCTOBER 24, 2023
Considerations of Handling High Potency Active Pharmaceutical Ingredients HPAPIs have difficult handling requirements which require various measures to be taken into consideration such as primary containment measures and secondary containment solutions. Secondary containment strategy include personnel training and awareness programs.
FDA Law Blog
JANUARY 1, 2024
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.
Pharmaceutical Technology
NOVEMBER 17, 2022
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.
The Pharma Data
JANUARY 27, 2021
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.
The Pharma Data
NOVEMBER 15, 2020
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.
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