Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.

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Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. Vetter Pharma-Fertigung GmbH & Co KG is conducting the parenteral manufacture and packaging for Trulicity. Please check your email to download the Report.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Compared to other dosage forms, tablets are simpler to manufacture, package, and transport. Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated. Please check your email to download the Webinar.

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ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Currently, it takes time and/or communications (e.g.,

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ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Currently, it takes time and/or communications (e.g.,

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Pharmaceutical Technology

JANUARY 12, 2023

That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. Solid state reactions occur much more slowly than liquid interactions. A great example is aspirin. Its half-life is only 50 hours if prepared as a solution. That is the reason aspirin is only sold as a solid.

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Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Please check your email to download the Whitepaper.

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Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Please check your email to download the Webinar.

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Packaging FDA Communication 52

Pharmaceutical Technology

NOVEMBER 28, 2022

We source as much of the materials as we possibly can locally, even packaging,” he notes. When we need new packaging, it is really simple to get and it is quick. “We have the skills. Wherever we can do it locally, we do. It generally does speed up supply; things get to the factory quicker. Printing is done in Glasgow.

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Pharmaceutical Technology

MARCH 22, 2023

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds.

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Pharmaceutical Technology

FEBRUARY 23, 2023

Quotient Sciences supported a standalone DCS classification and formulation development package. A recent example of this was for a compound at the candidate selection stage. Permeability was high and solubility at 24 hours in intestinal buffer was less than the expected therapeutic dose, so solubility was classified as “low”.

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Pharmaceutical Technology

FEBRUARY 7, 2023

They can also give their feedback on the design of the clinical trial, if the comparator reflects the standard of care, and if real-world evidence is part of the evidence requirement package.” Overall, it is never too soon to begin market access activities, but it can easily be too late. Please check your email to download the Case Study.

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Pharmaceutical Technology

MARCH 7, 2023

Due to rising healthcare spending, launch of novel treatments, and the rise of chronic diseases in an aging population, the global pharmaceutical packaging equipment market is rapidly expanding. Recent analysis valued the market [i] at USD 8.5 billion in 2021, which is expected to reach $15.77

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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). Nature Communications 12, no. Biotechnology Progress 36, no. 3 (2020):e2970.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. Accumulus Synergy White Paper. You may unsubscribe from these ISPE communications at any time.

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