news
Novel cancer therapeutic synthesised by Stanford researchers
The natural compound tigilanol tiglate was produced in a lab for the first time by scientists at Stanford University, suggesting it could provide treatment for a variety of cancers.
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Active Pharmaceutical Ingredient (API)
news
OSD contract manufacturing market valued at $54.7 billion by 2030
Outsourcing the production of oral solids is estimated to be the primary influencer for the contract manufacturing market in the next decade, using lessons learnt from the COVID-19 pandemic.
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Economics and risks of FDA’s Quality management maturity rating programme
Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…
news
HPLC-MS/MS for NDMA impurity determination in sartans
EPR summarises the development of a HPLC method for the detection, separation and quantification of N-nitrosodimethylamine (NDMA) in both olmesartan API and finished formulations.
news
HPLC determination of common cold formulations
EPR highlights a high-performance liquid chromatography (HPLC) method which enables the detection of both chlorpheniramine maleate and ibuprofen in formulation.
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GSK requires supplier sustainability compliance from 2023
New climate responsibility for the GSK supply chain will come into force from 2023, helping the biopharmaceutical giant to achieve their aspirational environmental targets.
news
Green HPLC method enables antipsychotic determination
EPR highlights a green high performance liquid chromatography (HPLC) method that successfully determined four common antipsychotics in formulation.
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Lonza expands HPAPI manufacturing suite
Lonza’s HPAPI multipurpose suite in Visp, Switzerland now includes enhanced capability for antibody-drug conjugate (ADC) payload production.
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Is localisation the answer for pharmaceutical supply chain resilience?
Highlighting the findings of a recent supply chain report, EPR’s Hannah Balfour discusses measures pharmaceutical suppliers may adopt to establish demand- and crisis-resistant supply chains. Commenting on the findings, Ernst & Young Global Limited colleagues Famke Krumbmüller, Derron Stark and Olaf Zweig elaborate on the impact and lessons learned through…
whitepaper
Whitepaper: PAT leads the way in the adoption of continuous manufacturing processes
Martin Gadsby, CEO & Director at Optimal Industrial Technologies and Flavio Belvedere, Co-Founder of ABCS Srl, look at the benefits of PAT and the aspects to consider when deploying it.
news
Evolving real-time dissolution prediction and product release
EPR highlights the development of a model to predict dissolution of sustained release formulations based on Raman process analytical technology (PAT) sensor data that could enable real-time release testing.
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Advancing autonomous API reaction optimisation
A novel flow reactor platform was able to self-optimise a range of variables within a multi-step reaction by leveraging process analytical technologies (PAT) and chemometric models.
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Assessing the scale of pharmaceutical crime using API content
Reviewing the active pharmaceutical ingredient (API) content in essential medicines failing quality analyses in low- and middle-income countries (LMICs) reveals that more than 12 percent are substandard or falsified.
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API nitrosamines: method sensitivity issues
Here, David Elder discusses the risks presented by active pharmaceutical ingredient nitrosamines and explains how European and US guidance differs on their acceptable levels.
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Efficient water determination accelerates API development
Contract development and manufacturing services for active pharmaceutical ingredients (APIs) must meet the requirements of customers and regulatory bodies alike. In the process control lab of the CARBOGEN AMCIS AG pilot plant in Bubendorf, Switzerland, accurate and efficient Karl Fischer titration workflows for water determination offer fast and reliable decision…
