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Synthesis and Route Design to Tackle API Complexity
22 July 2024 | By
These longer synthetic pathways present challenges for process chemists hoping to achieve an efficient API manufacturing process.
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QA/QC
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Improving aseptic connections throughout the manufacturing process
As companies are adapting to EU GMP guidelines for Annex 1 - Manufacture of Sterile Medicinal products, there have been numerous discussions involving the terms sterile and aseptic, as if they were synonymous. Vanessa Vasadi Figueroa, Chief Microbiologist at VVF Science® and Executive Director of Microbiology & Sterility Assurance at…
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Pharma Horizons: Formulation
European Pharmaceutical Review's latest Pharma Horizons report provides insight on key developments within pharmaceutical drug formulation for drug development, pharmaceutical manufacturing and quality control.
news
European Pharmacopoeia makes milestone pyrogen testing commitment
The "historic" decision from the Ph. Eur. follows publication of its texts relating to the rabbit pyrogen test (RPT) replacement strategy.
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Endotoxin standards: reflection and recommendation
Dr Radhakrishna Tirumalai and Karen Zink McCullough reflect on the recent opportunity to update the user requirements document relating to reference endotoxin standards.
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Pharma’s attitudes on AI revealed
Artificial intelligence (AI) is generally being embraced in the pharma and life science sectors, but concerns around data accuracy and transparency remain, a new survey reveals.
webinar
Simplifying complex dosage forms with advanced encapsulation
15 July 2024 | By ACG Worldwide
This webinar explores the unique manufacturing challenges of multi-formulation capsules and how these dosage forms can enhance treatment efficacy and patient compliance.
webinar
Unmasking the unknown: how mass spectrometry delivers accurate identifications
15 July 2024 | By Nelson Laboratories
In this webinar, learn more about advanced techniques like mass spectrometry which can help identify unexpected impurities in drug substances and drug products.
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Advanced techniques fuelling demand for liquid chromatography reagents
The versatility of liquid chromatography is propelling demand for high-quality chromatography reagents, the report stated.
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Using rack systems to reduce thermal interactions between vials during freezing
Formulation experts from Polytechnic of Turin, Italy, discuss the impact of freeze-drying on the integrity and stability of pharmaceuticals and how mathematical modelling can improve understanding of the freezing process.
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Cleanroom microbiology: single-temperature incubation for EM
Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges…
news
Optimising reverse-phase chromatography for molnupiravir production
The research offers insight into optimising chromatographic separation outcomes through precise control of measures such as flowrate and column length, supporting potential for drug development.
whitepaper
Application note: Automated nucleic acid amplification assay for mycoplasma detection in cell and gene therapy products
Ambili Menon, Pharma Quality Control, bioMérieux Inc. addresses the task of microbiological testing for advanced therapeutic medicinal products.
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Application note: Validating recombinant cascade reagents in 3 simple steps
Endotoxin testing continues to evolve alongside the industry’s need for more sustainable methods that reduce ecological impact. Nicola Reid, Associate Director of Endotoxin Products, Charles River Labs, reflects on these developments which are driven by the 3Rs (replacement, reduction and refinement).
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Guide to Data Integrity 2024
In this Guide to Data integrity articles explore the role of data integrity in CCS, AI and ML as well as biopharma manufacturing.
