European Biopharmaceutical Review |
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In Brief
Remembering Alzheimer's
EBR’s Industry Advisor, Emile Bellott, considers the growing urgency for a treatment to combat Alzheimer's disease to ensure the quality of life for a population guaranteed to live longer than any previous generation.
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Contract Development and Manufacturing Organisations
The Quality Paradox of Development in a CDMO
Alastair Waugh at 3P Biopharmaceuticals walks us through the challenging role of a contract development and manufacturing organisation and describes the balance of maintaining both work rate throughput and GMP compliance.
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Novel Approach for the Early Detection Sepsis
A Viable Solution
Until now, molecular diagnostic technologies for the detection of bacteria in blood have focused solely on the identification of DNA, but Arcis’ Dr Jan Rodgers and Dr Pablo Castan write on a game-changing new bacterial detection technology.
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CRISPR-Cas9
Beyond Biopharma
ERS Genomics’ Trevor Collingwood dives into the ambitions, successes, and future possibilities of CRIPR-Cas9, and the way that it has set itself apart from other platforms.
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Q&A: Drug Repurposing for Rare Diseases
Fit for Repurpose
Drug repurposing presents an encouraging possibility for finding cures, especially for rare diseases. EBR sits down with Hermann Mucke from H. M. Pharma Consultancy to deliberate the financial and other implications of drug repurposing for rare diseases.
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Generic Competition
Levelling the Playing Field
Charlotte Tillett, Astrid Arnold, and Joe Armstrong at Stevens & Bolton examine the July 2019 manufacturing waiver introduced by the EU and the effects it has and will continue to have on generics and biosimilars.
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Flow Monitoring in the Biotech Industry
Supporting Closed Operations with Flexible Single-Use Solutions
Article contributors at SONOTEC delve into single-use solutions and how to utilise noninvasive flow sensors effectively.
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Medicinal Cannabis
Why the Regulation of CBD Isn’t ABC
Greer Deal at Global Regulatory Services maps the controversial history of cannabis, the fast-changing regulations for cannabisderived products, and the effect all the aforementioned may have on the market for cannabis-based drugs.
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The Genetic Revolution
Is Genetic Anonymity Possible?
Dr Tal Sines and Ofer A Lidsky at DNAtix consider the hardly new, but still relevant, notion of a genetic revolution, and what this means in a modern context compared to when the term was first coined.
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The Future of Vaccination
The Path to a More Effective Influenza Vaccine
Vaccinations play a crucial role in the treatment and, more importantly, prevention of many deadly diseases. However, Dr Scot Roberts at Altimmune argues that there is room for innovation.
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Vaccination Research
Virus-Like Particles: Versatile Platforms
Vaccine innovation remains an agreed requirement among the pharma industry, and it is in this climate that virus-like particles have gained commendation; David Wetzel at ARTES Biotechnology and Jo-Anne Chan at Burnet Institute discuss.
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Diagnostic Reagents in Dengue Vaccine Development
Going Viral
The Native Antigen Company’s Dr Andy Lane discusses life-threatening flaviviruses such as the Dengue virus, and considers the part vaccines have to play in the combat and eventual eradication of these viruses.
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Safeguarding Biopharmaceutical Data
Integrity and Compliance
Data integrity is a critical part of every pharmaceutical company. Thermo Fisher Scientific’s Kimberly Remillard writes on the importance of maintaining integrity, and the possible consequences of data misuse.
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Achieving Data Quality in Pharma Traceability Systems
The Elegant Fundamentals
Amit Sewak at rfxcel takes you through the fundamentals of ensuring the accuracy of pharmaceutical data; ranging from respecting the human element to effectively utilising the technology at your disposal.
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Q&A: Data Regulations
A Guiding Light
Shweta Nair at Advanced Instruments sits down for an interview with Angela Bazigos, CEO of Touchstone Technologies Silicon Valley and co-author of 21 CFR Part 11 FDA guidelines.
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Data Compliance and Integrity
Why is Data Integrity Important?
Laura Grey and Santosh Tymms at Quanticate outline the reasons why data integrity is imperative for every pharmaceutical company and consider how it can best be achieved.
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Building Patient Engagement and Secure Drug Discovery
Data Privacy, Compliance, and Security
Much has been made of the trials and tribulations of complying with data regulations; however, Paul Drake at Signant Health argues there may be significant opportunities to be gained from data compliance.
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