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Video: Single versus 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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Biosimilars
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Fact Sheet: Process analytical technology and real-time TOC testing of pharmaceutical grade water systems
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
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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.
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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…
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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.
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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.
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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.
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European Pharmaceutical Review Issue 1 2021
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…
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Whitepaper: Upstream process intensification
Strategies for upstream process intensification can be leveraged for cell line development, the seed train, production and cell culture media formulation.
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Brochure: G-CON cleanroom POD
G-CON cleanroom PODs. Reliable, flexible prefabricated cleanrooms for the biopharmaceutical industry. On budget and on time.
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EMA committee recommends 13 medicines for approval in January meeting
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
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Article: Regulatory guidance in designing a CCI testing strategy
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
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On-demand webinar: Best practices for cleaning and disinfection
This on-demand webinar focuses on the importance of cleaning and disinfection, covering legal requirements and the global guidelines for disinfection in cleanrooms.
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Factsheet: Total Organic Carbon (TOC) back to basics
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
