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Validation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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Analytical techniques
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Whitepaper: Manufacturing with Bruker’s Fourier PAT
Maximize the effectiveness and benefits of data-driven, real-time control, on-line NMR analysis coupled with process analytical technology (PAT).
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Analytical technique may advance medical cannabis quality control
Combining near-infrared spectroscopy (NIR) hyperspectral imaging (HSI) and machine learning could offer a simpler, non-invasive alternative to established analytical techniques such as chromatography, research suggests.
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Enhancing biopharma workflows with the power of UV/Vis spectroscopy
8 March 2024 | By Thermo Fisher Scientific
Discover the valuable role ultraviolet-visible spectroscopy can play in quickly and accurately monitoring a drug as it moves through the research & development workflow and enabling quality and regulatory compliance through the manufacturing process.
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Employing MALDI-TOF MS for microbial identification in sterile drug manufacturing
A study investigating microbial risks of the entire manufacturing process has identified MALDI-TOF MS as a promising first-line tool for pharmaceutical environmental monitoring.
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Product hub: High fidelity process control with Bruker’s Fourier PAT
Bringing a wealth of structural information and direct quantification to the lab or plant, the Fourier PAT benchtop NMR reduces tedious calibrations and increases (bio)process understanding and control, hence further reducing risks and cost.
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Analytica 2024 in overview
Between 9 - 12 April 2024, the world’s leading trade fair analytica will once again open its doors in Munich to the international laboratory industry. At analytica, industry experts, exhibitors and visitors gather to explore the latest developments in laboratory technology, analysis and biotechnology. The fair, covering the entire spectrum…
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SGS joins forces with Agilex Biolabs
SGS, the world’s leading testing, inspection and certification company, is excited to announce a partnership with Agilex Biolabs, Australia’s largest and most technologically advanced regulated bioanalytical laboratory. This collaboration marks a significant step in strengthening SGS’s global footprint in the bioanalysis services sector.
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Overcoming challenges of continuous antibody manufacture
During monoclonal antibody (mAb) manufacture, continuous flowsheets could offer ~20 percent–40 percent cost of goods (COG) saving over the batch process, for instance, during low commercial demand, a paper suggests.
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Nelson Labs facility expansion to benefit parenteral and ophthalmic drug product manufacturers
The new Pharmaceutical Center of Excellence from Nelson Labs offers state-of-the-art chemistry manufacturing and controls (CMC) analytical testing support.
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Process analytical technology: applications and opportunities for pharma
15 February 2024 | By European Pharmaceutical Review, sponsored by Mettler Toledo, Bruker and 908Devices
During this virtual panel, industry experts will discuss the latest advances and applications of process analytical technology in the pharmaceutical sector.
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Raman and machine learning show promise for online monitoring of bioreactors
The approach applied in the research on bioreactors represents a significant advancement over traditional methods, according to the researchers.
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Biosensing technique promising for whole-genome detection
The bacterial detection method is robust and highly sensitive over a wide concentration range and does not require DNA amplification, research suggests.
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Revised ISO guideline highlights toxicological evaluation of extractables and leachables
Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
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Will new therapeutic agent replace antibodies for bacterial detection?
Aptamers offer a “cutting-edge approach” for identifying gram-negative bacterial pathogens, a paper suggests.
