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WuXi Biologics achieves large-scale manufacturing milestone
The environmentally-sustainable inaugural manufacturing run at WuXi Biologics’ GMP-certified facility in Ireland combined four 4,000-litre single-use bioreactors.
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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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ebook: Filling gaps in managing large volumes of biologics
Aseptic aliquotation and cryopreservation of bulk drug substances are crucial process steps in bioprocessing that require an efficient process.
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Whitepaper: What Are Some Hidden Risks Associated with Isolators?
Uncover the pivotal role of isolator technology in enhancing safety and productivity in the pharmaceutical and chemical industries.
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Applying ISO/TR 14644-21 – Airborne particle sampling techniques
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.
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Whitepaper: Imaflow® Platinum Silicone Brewing in Coffee Vending
18 January 2024 | By
Imaflow® Platinum cured silicone tubing is heat resistant, flexible, and available with colour coded options (NSF-51 Certified for hygiene)
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Whitepaper: Reducing gas consumption by 20% during the micronization
Discover how the coaxial jet mill transforms micronization in pharma and chemical sectors, ensuring safety, efficiency, and sustainability.
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Video: Unveiling the science behind NGS
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…
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Cell and gene therapy: manufacturing and talent trends 2023
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.
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Application note: Role of in-house isolates in pharmaceutical quality control
This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.
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Novo Nordisk to expand French production facilities
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.
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Product hub: Rapid mold detection in as little as one day
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.
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New acquisition to support global gene therapy manufacturing
Acquisition of Forge Biologics by Ajinomoto Co., Inc. is set to extend global capabilities in AAV and plasmid gene therapy manufacturing for Ajinomoto, Co. Inc.
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SGS ISL marks two-year anniversary
We are thrilled to celebrate two years since International Services Laboratory (ISL) in Ringaskiddy, Cork, Ireland, became part of the SGS network.
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Guidance on machine learning-enabled medical devices published
The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have issued guidelines to reduce the regulatory burden for machine learning-enabled medical devices.
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FDA issues draft guidance on alternative tools for facility assessments
As part of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) reauthorisation negotiations, the US Food and Drug Administration (FDA) has issued new draft guidance on alternative tools for assessing drug manufacturing facilities.
