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Infographic: Maintaining data integrity
Maintaining Data Integrity. Did you know that lack of data integrity has been a top reason for FDA Drug GMP warning letters?
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Whitepapers/App Notes/Posters
Brochure: MET ONE 3400+ Air Particle Counter
The new MET ONE 3400+ Series PortableAirborne Particle Counter automates environmental monitoring for GMPcleanroom compliance.
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Biosimilar uptake will take more than competitive pricing
This article explores what pharmaceutical companies could be doing to promote injectable biosimilar approval and consumer uptake.
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TXA127 enters multiple Phase II trials in COVID-19 patients
A pharmaceutical formulation of the human angiotensin peptide, TXA127, will enter Phase II trials in hospitalised COVID-19 patients not in intensive care.
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Phase III COVID-19 antibody trials initiated in Americas
Simultaneous Phase III trials evaluating Regeneron’s REGN-COV2 antibody as both a prophylactic and a treatment have begun in US and some South American locations.
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How to start up an ATMP clinical trial
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues or cells. They offer revolutionary opportunities for the treatment of disease and injury; however, developers face a complex regulatory and developmental landscape to bring ATMPs to market. Here Magdalena Czarnecka offers guidance and advice on effectively initiating an ATMP…
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European Pharmacopoeia publishes new chapter regarding BET testing
The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
news
CBD could reduce behavioural problems in children with intellectual disability
A new study has shown that in children and adolescents with an intellectual disability, cannabidiol (CBD) reduced severe behavioural problems.
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Comparison of new vaccine approaches – COVID-19
The promise of virally vectored DNA and mRNA vaccines is tremendous in terms of vaccine safety and speed of response to new pathogens. This article explores why these approaches have attracted attention in light of the COVID-19 pandemic and why they are highly appropriate for rapid vaccine development and deployment.
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Five patent issues that European biosimilar developers should consider before entering the US market
As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.
Whitepapers/App Notes/Posters
Application note: Why extractables and leachables matter
Nelson Laboratories, with their unique database of over 6,000 compounds for detection, discuss the testing requirements for extractables and leachables and why identification and quantification in extraction studies will become increasingly crucial for pharmaceutical and medical device product safety and integrity.
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Epidyolex (cannabidiol) reclassified as Schedule 5 in UK, relaxing control over drug
GW Pharmaceuticals's Epidyolex (cannabidiol) has been changed from a Schedule 2 drug to a Schedule 5 drug, making it exempt from virtually all controlled drug requirements.
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Enabling compliant data management with a comprehensive informatics solution
This guide to from Thermo Fisher Scientific explores how laboratory data management solutions help thier pharmaceutical and biopharmaceutical customers to address their business challenges.
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bioBoaVista manufactures customised media for COVID nasal diagnostic tests using the Flexicon PF7
bioBoaVista showcases its viral transport medium, that can stabilise samples, for efficient nasal tests for the diagnosis of COVID-19.
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Bioprocessing & Bioproduction In-Depth Focus 2020
This in-depth focus includes articles detailing five important considerations for European companies entering the US biosimilar market and explaining why virally vectored DNA and mRNA vaccines could prevent the spread of COVID-19.