Pharmaceutical Technology

NOVEMBER 15, 2022

When it comes to vaccines and other high-value biologics, it is essential that effective formulations go hand in hand with safe delivery. An example is the ability of a patient suffering from venous thrombosis to perform their own injections of heparin – an anticoagulant often packaged in a prefilled syringe.

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Packaging Vaccines Dosage Compounding 52

ISPE

NOVEMBER 22, 2022

I presented on planning and executing and designing fill lines, RABS, Isolators, and transfers – along with the differences between processing potent compounds versus non- potent compounds. When I started attending and speaking at the ISPE Aseptic Conference in the 2000s, I came to grow and learn. Learn More & Register.

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Compounding Packaging Dosage Vaccines 98

ISPE

MARCH 8, 2023

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

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Compounding Compounding Pharmacies Packaging FDA 52

ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Burke, PhD. 1 September 2022.

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Documentation FDA Packaging Communication 52