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Rabbit pyrogen test to be replaced by European Pharmacopoeia
The European Pharmacopoeia will put an end to the rabbit pyrogen test in the next five years and encourages industry to adopt the monocyte-activation test instead.
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Analytical techniques
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Scientific briefing: Dissolution development Parvulet technology with oral tablets
Parvulet™ Technology is a patented oral dosage form capable of being dispensed to patients in tablet or powders, and converted into a semi-solid with water.
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Application note: CrystallineRR and Raman spectroscopy
Learn here how to identify polymorphic transformation by using Raman and the Crystalline instrument.
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Pharmaceutical QC market to value $9,700mn by 2027
Market research shows increasing pharmaceutical R&D investment and advances in quality control (QC) technologies will drive pharmaceutical QC market growth.
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Whitepaper: Digital transformation of medical devices sterilisation by EtO
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
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How COVID-19 has accelerated digital transformation and how laboratory orchestration platforms are changing the landscape
Thermo Fisher is ready to partner with your global team to help you meet your business goals and get life transforming treatments onto the market as quickly and safely as possible.
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Application note: Software that makes data integrity compliance visible
Read this application note to discover the software that makes data integrity compliance visible: Shimadzu LabSolutions database (DB) or client/server software (CS).
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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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Application Notes Supplement 2021
Here, industry experts share their research, guidance and pharmaceutical knowledge.
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O-glycan analysis of therapeutic proteins enabled by O-glycoprotease
Glycosylation of therapeutic proteins is important to biologic drug development and is a critical quality attribute that is monitored during manufacturing. Analysis of O-glycans is technically challenging compared to that of N-glycans. In this review, Xiaofeng Shi, Saulius Vainauskas and Christopher H Taron summarise current O-glycan analytical approaches, describe the…
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ICH M13: Bioequivalence guidelines
Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
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Enabling compliant data management with a comprehensive informatics solution
Learn about how SampleManager LIMS software drives compliance and data integrity by providing clear traceability for all laboratory activities and data.
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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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Solid- and Liquid-State NMR for monitoring of polysaccharide antigen in the manufacturing process
Francesco Berti, Scientific Director at GSK Vaccines - Siena, Italy, reveals how NMR spectroscopy tools are invaluable in vaccine production.
