European Pharmaceutical Review

DECEMBER 26, 2023

Achieving cost optimisation requires identifying opportunities for process simplification, improving productivity and optimising resources Gene therapy products are very complex and manufactured with a cellular host substrate, which makes analytical characterisation far more challenging.

Packaging 87

Packaging Vaccines 87

Pharmaceutical Technology

MARCH 22, 2023

Process intensification can loosely be described as making more product with the same or fewer resources. For example, running a bioreactor in perfusion mode instead of batch, or using continuous instead of batch chromatography. Existing technologies could also be run in a different way.

Documentation 52

Documentation Communication 52

ISPE

MARCH 8, 2023

Identification and Quantitation of Vesuvius 2117 Particles in Bioreactor Fluids from Infected Chinese Hamster Ovary Cell Cultures.” Additionally, not all manufacturers have the resources to adopt more effective technology to address contamination issues. “Tylenol Maker to Pay $25 Million for Selling Metal-Contaminated Drugs.”

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

ISPE

MAY 9, 2023

plant containing eight 2,000-L single-use bioreactors; Pfizer, which has a 230-acre site focusing on vaccine intermediates and gene therapies that also includes microbial fermentation, purification, conjugation, and cell banking; and Astellas, which opened its 135,000-sq. -ft. 2 Research Triangle Park. Accessed 25 January 2023.

Vaccines 94

Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

ISPE

SEPTEMBER 11, 2023

Examples include bioprocessing bags (replacing glass flasks and tanks), single-use bioreactors and accessories (replacing stainless steel bioreactors), aseptic connectors, and transferring assemblies and filters. We will use technology transfer from an approved sending site to a proposed receiving site as an example.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 15, 2023

1 This view prioritizes steps that reduce the use of natural resources and the release of undesirable products such as carbon to the atmosphere or plastics to landfills. 17 Improving production planning and resource management optimizes facility and service utilization and overall energy consumption. 7 An integrative (vs. Holstein, H.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

OCTOBER 27, 2022

Yield vs demand vs capacity: Will the culture volumes and bioreactor style be similar or divergent between products/modalities? The TT approach requires introduction of plasmids to the N-stage production bioreactor to produce the loaded viral particle. Biosafety Resource Guide.” Accessed 11 August 2021. GMO Office website.

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Packaging Communication Immunization Vaccines 52