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EMA’s transformative treatments of 2020
In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
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EU doubles its COVAX contribution, promising €1bn for safe and effective COVID-19 vaccines
The addition of €500 million to the EU’s existing COVAX Facility pledge was announced at the G7 summit virtual leaders' meeting.
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Video: Single vs. multilayer film in cold chain bioprocessing
Our video highlights how Aramus™ bag assemblies overcome single-use bag failures at cold temperatures with a new single-layer fluoropolymer material.
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Resource library: Smart up your lab with EMSURE® products for pharma QC
See how compliant products, unique packaging, and smart labels make EMSURE® inorganics and solvents the smartest choice for pharmaceutical analysis.
Whitepapers/App Notes/Posters
Whitepaper: Why extractables and leachables matter
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
article
New regulatory landscape for biosimilars in the UK and EU post Brexit transition period
As the UK enters new territory following its departure from the EU, legal experts Marie Manley and Chris Boyle from Sidley Austin explore the resultant consequences for biopharma companies and the regulatory opportunities that lie ahead.
article
Established and new mass spectrometry applications to drug discovery and development
Mass spectrometry has numerous applications in pharmaceutical research, from initial discovery through to characterisation and quality control. In this article, Dr Ioannis Papayannopoulos details the role of mass spectrometry in pharma R&D by highlighting established and novel applications of the technique in drug discovery and development.
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Biosimilar uptake: a clinician’s perspective
To ensure that clinicians buy into biosimilars, it is important that they understand how products are analysed and compared to the originator molecules. Dr Fraser Cummings and Jonathan Sweeting discussed this issue at a recent virtual roundtable event, where they highlighted the complexities of biosimilar development pathways and approval processes. Here, Nikki Withers shares the…
article
Manufacturing of CAR T-cell therapies: an overview
The emergence of CAR T-cell therapies has ignited a revolution in the field of cancer treatments. While existing products show outstanding curative capability, they are hampered by significant clinical and commercial challenges, many of which stem from their manufacturing process. Maciej Nakoniecznik discusses how a combination of biological and technological advances…
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Brochure: Fast and simple plasma protein binding studies
Supel™ BioSPME 96-Pin Devices vastly outperform current sample preparation techniques for plasma protein binding studies and free fraction analyses.
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Application note: In-process monitoring of headspace oxygen levels
Monitoring headspace oxygen to ensure stability and potency of finished oxygen sensitive product.
article
Bioprocessing & Bioproduction In-Depth Focus 2021
In this in-depth focus, discover how biological and technological advances could enhance the clinical capabilities of CAR T cell therapies and explore why clinicians need to be better educated about the development and licencing of biosimilars.
news
EMA initiates rolling review of CureVac’s CVnCoV COVID-19 vaccine
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
news
EC approves first high concentration, low-volume adalimumab biosimilar
YuflymaTM (CT-P17) has been approved for the treatment of thirteen chronic inflammatory diseases, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, in Europe.
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Catalogue: Standard cleanroom POD
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.