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Automation to guide technology shift in aseptic environments

European Pharmaceutical Review

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. It provides tools for the process improvements using robotics, which is well-established in other manufacturing sectors. Tanzini et al.

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Biologics – manufacturing trends in a modern facility

European Pharmaceutical Review

These innovative technologies include highly automated, fully digitalised process analytics technologies (PAT) , as well as automated and robotic testing technologies to confirm product quality. The complex and intricate processes involved in upstream and downstream manufacturing are highly refined, he notes.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

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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A Proposal for a Comprehensive Quality Overall Summary

ISPE

The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. The purpose of the QTPP is to link the attributes of the DP back through the TPP to the needs of the intended patient population.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. The purpose of the QTPP is to link the attributes of the DP back through the TPP to the needs of the intended patient population.

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Oligonucleotides: A Cornerstone for Therapeutics & More

ISPE

As a result, some companies have challenged the paradigm by forgoing lyophilization entirely, opting to provide solution phase API to drug product facilities for filling and packaging. Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

Sustainability Tools and Design Processes When promoting of an initiative’s environmental sustainability ES, we should include a more comprehensive context that considers planet (natural capital), people (social capital), and profit (economic capital). However, it can also reduce the environmental burden of a process. Press Room.