The latest innovations in cell bank manufacturing can help accelerate biologic therapeutics program while reducing risk and simplifying overall strategy. As industry expectations continue to evolve, ...
One of the main goals of pharmaceutical regulatory rules is to keep environmental contamination at a minimum. According to the EU GMP Annex 1 regulatory standard for sterile drug products, a ...
The US Food and Drug Administration (FDA) recently issued two warning letters to a sterile drug manufacturer and an over-the-counter (OTC) drug maker in the US for multiple violations of good ...
India-based Malladi Drugs & Pharmaceuticals and Labocont Industrial SRL’s drug manufacturing facility in the Dominican Republic drew US Food and Drug Administration (FDA) warning letters over failures ...
Adopting IDEA—identify, define, explain, apply—streamlines contamination control. Infection control professionals can mitigate risks through prevention, intervention, and training, ensuring safer ...
With the continued proliferation of Advanced Therapeutic Medicinal Products (ATMPs), therapy development, and marketed products available, the modern manufacturing process must adhere to the ...
UK CDMO Upperton can now manufacture sterile investigational medicinal products at its new 7,000 sq ft facility in Nottingham ...
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