Adare’s Optimµm® technology offers a unique and efficient method of fabricating monodisperse microparticles at reduced development time.
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Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Learn how you can go about changing QC test methods and how this can go a long way to helping your lab achieve data integrity compliance.
Improve efficiency and return on investment by adopting molecular spectroscopy techniques in pharma manufacturing
3 August 2021 | By Thermo Fisher Scientific
Join Thermo Fisher Scientific on 7 September at 15:00 BST, to discover the differences between FTIR, NIR and Raman spectroscopy, learn how spectroscopy is applied in quality control labs and hear how implementation of these techniques increased efficiency and minimised costs.
Using a proprietary Stratµm TM technology, we have created 50 µm capsules with an aqueous core and thin PLA shell.
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
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.
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.
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
In this in-depth focus, find out about the key points to consider when implementing new software in the pharma development space and the current positions of the EMA and FDA with regards to nitrosamine contaminants.
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.
The journey from large molecule to approved biotherapeutic is long, costly, complex and fraught with risk – yet rewards for success are substantial.
Evonik and Stanford University will collaborate over three years to advance an innovative polymer-based drug delivery system that could further the use of mRNA therapeutics.
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.