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Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

In the EU, a joint PFAS Restriction Proposal under REACH was submitted, aiming for a full ban by 2028/2030. billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. There is worldwide concern around the use of PFAS.

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A New Regulatory Approach to Drive Sustainable Medicines

ISPE

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). 7 An integrative (vs. 7 An integrative (vs.

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Sustainability: Corporate Ambition, Governance, & Accelerated Delivery

ISPE

Transforming Our World: The 2030 Agenda for Sustainable Development.” a time horizon of 2030 is much more engaging than 2050). Research and development, manufacturing, commercial (sales and marketing) activities, and their extended supply chains including logistics are all within this scope. 1 United Nations. October 2015.

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Cell and gene therapy: The vital role of logistics

Pharmaceutical Technology

The projected growth of the cell and gene therapy market GlobalData estimates that the cell and gene therapy market will achieve global sales of $76.03bn by 2030, up from $5.88bn in 2023, with a compound annual growth rate (CAGR) of 44% over the seven years analysed. How will RFK Jr’s American dream for vaccines play out?

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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™