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Scientific briefing: Formulation of aqueous core poly (lactic acid) microcapsules
Using a proprietary Stratµm TM technology, we have created 50 µm capsules with an aqueous core and thin PLA shell.
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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.
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FDA suggests principles for implementing bio-fluorescent particle counters
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.
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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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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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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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Manufacturing, Packaging & Logistics In-Depth Focus 2021
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.
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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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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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Collaboration to develop novel polymer-based drug delivery system for mRNA
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.
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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.
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New consortium to develop PAT for cell and gene therapies
The Cell and Gene Therapy Catapult’s new consortium aims to accelerate therapeutic development by developing process analytical technologies (PAT) for cell and gene therapy manufacturing.
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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.
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DFE pharma joins UK’s leading initiative for innovation in drug manufacturing
DFE Pharma is the latest member of the UK’s Medicines Manufacturing Innovation Centre and will work on Grand Challenge 1: improving the manufacture of oral solid dosage medicines.
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On-demand webinar: Contamination control strategy essentials
This webinar presents the fundamentals of a contamination control strategy including forms of contamination, as well as cleaning and disinfection.
