news
FDA approves first interchangeable biosimilar insulin product
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.
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Biosimilars
whitepaper
Whitepaper: Cleaning validation
This whitepaper discusses cleaning validation and the considerations required for a successful outcome.
whitepaper
Brochure: CrystalBreeder do more with less
Enhance your early stage solid state screening with the CrystalBreeder bench-top system.
whitepaper
Application note: CrystallineRR and Raman spectroscopy
Learn here how to identify polymorphic transformation by using Raman and the Crystalline instrument.
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Bioprocessing & Bioproduction In-Depth Focus 2021
Download this in-depth focus to discover why new licensing guidance could prompt a biosimilar boom in the UK and learn about recent developments in O-glycan analytical approaches for therapeutic proteins.
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New regulatory guidance could lead to UK biosimilar boom
New guidance on the licensing of biosimilar products that reduces unnecessary clinical trials is expected to put the UK ahead of Europe and facilitate a boom in these essential life-saving medicines, creating greater patient access and saving the National Health Service (NHS) hundreds of millions of pounds. It could also…
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VIRTUAL ROUNDTABLE HIGHLIGHTS: Emerging tools for the analysis of biologics and biosimilars
In this virtual roundtable, Scott Bradley (Principal Research Scientist, Eli Lilly and Company), Joan Malmstrøm (Principal Scientist, Novo Nordisk) and Kelly Sackett (Principal Scientist, Pfizer) exemplified how high-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information about protein structure and dynamics. Here, the participants offer some…
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Supply of biosimilars and generics with Adrian van den Hoven, Medicines for Europe
In this interview, Adrian van den Hoven, Director General of Medicines for Europe, discusses all things supply of generic and biosimilar medicines for the continent. Also, in a bonus video, Adrian discusses challenges disrupting access to biosimilars and generics in Europe.
news
Global API market to value $300 billion by 2030
Researchers anticipate the growth of the aging population and rising investment in biologic drugs to promote the expansion of the global active pharmaceutical ingredient (API) market.
whitepaper
Infographic: Simplified bacterial endotoxin testing
Endotoxin automation using microfluidics enables simpler, compliant processes for pharma QC, QA, validation and IT. BET assay setup is simplified and less LAL is required.
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European Pharmaceutical Review Issue 3 2021
In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…
whitepaper
Brochure: Welcome to bioprocessing – pathways for pioneers
The journey from large molecule to approved biotherapeutic is long, costly, complex and fraught with risk – yet rewards for success are substantial.
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Video: BET automation is easy and simple with microfluidics
Endotoxin automation doesn’t mean complex instrumentation and setup. See how microfluidics enables easy BET assay setup so QC labs achieve high throughput with less hands-on time.
whitepaper
Application note: Stability of protein formulations and their importance
The Crystalline offers the possibility to quickly obtain data on the stability of protein formulations by making use of the real time digital camera.
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On-demand webinar: Celsis® for sterility – product spotlight
A rapid sterility test method that can be validated as quickly and confidently as it provides test results.
