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The role of GAMP 5, data integrity and QbD in pharmaceutical quality assurance

European Pharmaceutical Review

As for its benefits in pharmacovigilance, the paper explained that GAMP 5 “helps organisations maintain high-quality standards in adverse event reporting and analysis, ensuring the safety of patients and the integrity of data. GAMP 5 update: computerized system expectations for pharma manufacturers Benefits of Pharma 4.0 Pedro et al.

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Is the pharmaceutical sector realising its potential for sustainable manufacturing?

European Pharmaceutical Review

Pharma within planetary boundaries One area lacking major gains is in the process of design, engineering, commissioning and maintaining a manufacturing plant itself. Creating more sustainable business processes is a pre-competitive activity; we all win when we make progress in sustainability and lose if we don’t.

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Pharmaceutical processing: Why the industry is turning to turnkey

Pharmaceutical Technology

In order to plug the gap between demand and capacity and win back their competitive advantage, many pharmaceutical and fine chemical companies are turning to pre-engineered, end-to end providers to fulfil their API demand. While pre-engineered and modular facilities are not a new idea, every turnkey project installation is unique.

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Maxion scoops £2m UK grant to develop autoimmune disease treatment

Pharmaceutical Technology

Maxion Therapeutics announced it has been awarded a £2m ($2.5m) grant from Innovate UK as part of a biomedical R&D funding competition. Antibody-based therapies provide enhanced efficacy and safety whilst reducing the need for frequent administration for autoimmune disease treatment.

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FDA grants QIDP and fast track designations for Eagle’s CAL02

Pharmaceutical Technology

It acts as a competitive decoy for bacterial virulence factors that contribute to complications, sepsis, septic shock and death following infection. The therapy comprises liposomes engineered to capture the virulence factors, which are produced by a wide range of Gram-positive and Gram-negative bacteria.

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Streamlining bioprocessing for gene therapy

European Pharmaceutical Review

The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. million for Hemgenix [AAV5-hFIX-Padua]). million for Hemgenix [AAV5-hFIX-Padua]). This enhances the commercial viability of USP.

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3 Insights From Re:Imagine Pharma Marketing 2020

Pharma Marketing Network

Chief Executive Officer of Arteric, Hans Kaspersetz presented how AI can help develop your competitive edge. Some of the many reasons people currently prefer telehealth over in-person doctor visits include convenience, flexibility, less wait time, safety, and easier routine follow-ups.