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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.
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.
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.
A rapid sterility test method that can be validated as quickly and confidently as it provides test results.
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.
This webinar presents the fundamentals of a contamination control strategy including forms of contamination, as well as cleaning and disinfection.
9 June 2021 | By Tecan
This on-demand webinar brings three leaders in the field together to discuss the new regulations, responsibilities across the whole supply chain, documentation, the notified body application process and key timelines.
Improved drug delivery with precision particle fabrication-enabling precise control over particle structure.
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.
Expanding solutions for challenging APIs through the coacervation process.
21 May 2021 | By Thermo Fisher Scientific
In this on-demand webinar, you will hear directly from industry auditors as they discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation and qualification for computerised systems in regulated laboratories.
