List view / Grid view
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.
Here, Chief Technical Officer, Mike Frodsham and Ryan Wilson, Head of Microbiome Services at SGS Quay Pharma, explore the chemistry, manufacturing, and control (CMC) challenges of developing drug products containing live anaerobic bacterial strains, used for treatments such as microbiome therapeutics.
The fluid management for mRNA, LNPs, pDNA and viral vectors for cryopreservation are often prone to inefficiencies. SUT optimizes the manufacturing process.
Discover how combining a spiral jet mill with an in-line classifier optimizes particle size distribution in pharmaceuticals, enhancing drug efficacy.
In its recent responses to FAQs relating to Annex 1, the European Medicines Agency (EMA) discusses bioburden guidelines for good manufacturing practice (CGMP) and good distribution practice (GDP).
The environmentally-sustainable inaugural manufacturing run at WuXi Biologics’ GMP-certified facility in Ireland combined four 4,000-litre single-use bioreactors.
Aseptic aliquotation and cryopreservation of bulk drug substances are crucial process steps in bioprocessing that require an efficient process.
Uncover the pivotal role of isolator technology in enhancing safety and productivity in the pharmaceutical and chemical industries.
23 January 2024 | By Particle Measuring Systems
Watch this webinar as GMP expert Mark Hallworth discusses the difference between cleanroom classification and monitoring of the new ISO 14644 Technical Report 21 focuses in section 4.0 and 5.2.
18 January 2024 | By
Imaflow® Platinum cured silicone tubing is heat resistant, flexible, and available with colour coded options (NSF-51 Certified for hygiene)
Discover how the coaxial jet mill transforms micronization in pharma and chemical sectors, ensuring safety, efficiency, and sustainability.
Virtual seminar presented by Christine Farrance, PhD, Senior Global Scientific Affairs Liaison of Microbial Solutions at Charles River designed to improve your understanding of how to leverage NGS to analyze the entire genome and mixed samples in a single, efficient test to identify, classify, and understand microbes in mixed and…
In this interview, Stephen Ward, Chief Manufacturing Officer and Jeanette Evans, Chief Business Officer, Cell and Gene Therapy Catapult, highlight key data from the organisation’s recent GMP Manufacturing Survey and Skills Demand reports, and present insight into the sector’s current and future landscape.
This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.
Using an investment of more than €2.1 billion, a planned expansion at one of Novo Nordisk’s strategic production sites will include additions such as aseptic production and the extension of its Quality Control Laboratory.
Quick to spread and difficult to detect, molds can compromise a facility in the time it takes to confirm their presence. The RMBNucleusTM Mold Alarm signals at the first sign of mold detection.
