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The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.
Our video highlights how Aramus™ bag assemblies overcome single-use bag failures at cold temperatures with a new single-layer fluoropolymer material.
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
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.
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…
Monitoring headspace oxygen to ensure stability and potency of finished oxygen sensitive product.
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.
YuflymaTM (CT-P17) has been approved for the treatment of thirteen chronic inflammatory diseases, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, in Europe.
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
In this issue we discuss whether clinicians know enough about the development of biosimilars to buy in, explore the biggest M&A trends in pharma and what to expect this year and consider the importance of disaccharides in the stabilisation of biologics. The journal also features articles on the fundamentals of…
Strategies for upstream process intensification can be leveraged for cell line development, the seed train, production and cell culture media formulation.
G-CON cleanroom PODs. Reliable, flexible prefabricated cleanrooms for the biopharmaceutical industry. On budget and on time.
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
This on-demand webinar focuses on the importance of cleaning and disinfection, covering legal requirements and the global guidelines for disinfection in cleanrooms.
