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Innovation in pharma manufacturing quality systems

European Pharmaceutical Review

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. That is because of the relative expense of emerging therapies and the pressure on pricing for continuing product lines.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

1 The changes form part of the 2020 Pharmaceutical Strategy for Europe will impact pharma and biopharma companies operating in Europe. The first is removal of the RDP extension for pan-EU launch within two years, instead requiring manufacturers to submit to local P&MA processes upon request by the member state.

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Leading speciality pharmacies in pharma

Pharmaceutical Technology

The speciality drug channel participants, including speciality pharmacies, biopharma companies, and distributors, are transforming their operations with automated and secure data systems and next-generation analytics, which will improve data collection, partner performance and strategy effectiveness. Payer and/or manufacturer reporting.

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What is the future of biologic medicines?

European Pharmaceutical Review

As a result, the market is expected to reach $719 billion by 2030, 1 Sigma Mostafa, PhD, Chief Scientific Officer at KBI Biopharma shared with EPR. These trends have an impact on manufacturing capacity. There are a lot of conjugated products in the clinical pipeline and novel conjugation partners and chemistries are being tried.

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Cell and gene therapy: manufacturing and talent trends 2023

European Pharmaceutical Review

o find out about the current trends in cell and gene therapy manufacturing, EPR spoke to Cell and Gene Therapy Catapult (CGT Catapult)’s Chief Manufacturing Officer, Stephen Ward, and Chief Business Officer, Jeanette Evans. Licensing of the manufacturing suites is expected in early 2024. So now we have a really nice blend.”

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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API).

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Developing an effective contamination control strategy

European Pharmaceutical Review

As part of The Future of Pharma/Biopharma Analysis 2023 , which took place on 28-29 June 2023, European Pharmaceutical Review ( EPR ) gathered an expert panel to discuss developing a modern contamination control strategy. Opening the session, moderator Tim Sandle highlighted six fundamental aspects of contamination control.