All Raw materials and supply chain (bioprocess) articles – Page 6
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NewsChallenges and opportunities in the CGT supply chain
This article explores the unique logistics and supply chain challenges of cell and gene therapy development and the future potential of this innovative sector.
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NewsNovel preservation method could improve storage of biologics
Light-assisted drying (LAD) is a new optical processing technique for forming trehalose amorphous solids to preserve biologics, while avoiding the freezing step necessary for lyophilisation.
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NewsKey vaccine adjuvant biosynthesised in yeast
According to research, the yeast-based process could not only make one of the most effective adjuvants more widely available, but also help lower the cost of vaccines overall.
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Whitepaper
Whitepaper: Molecular contamination control - odours, gases and toxics
Identify molecular contamination concerns in the pharmaceutical workspace and determine the right filtration solution for dealing with these problems.
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WhitepaperWhitepaper: High-temperature filters for sterilization and depyrogenation processes
In sterilisation tunnels the need for filtration is of the utmost importance. Choosing the right filter can have an effect on production yield.
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Whitepaper
Booklet: Air Filtration – Upgrades without compromise
Learn how you can upgrade your filtration choices without compromising on energy performance.
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NewsWHO proposes recommendations for preventing nitrosamine contamination
The World Health Organization (WHO)’s draft guidance on nitrosamines is applicable to manufacturers of excipients, active pharmaceutical ingredients (APIs) and finished pharmaceutical products.
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ArticleEuropean Pharmaceutical Review Issue 2 2024
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
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NewsBenefits of 3D printing for personalised medicine formulation
A study has demonstrated how 3D printing can be used to manufacture tailored, safe, and effective treatments for patients with rare diseases via pharmaceutical compounding.
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VideoWebinar: How Pfizer utilises Enzyme Indicator technology for bio-decontamination validation
Melanie Eggers is a Sterilisation Validation Project Support Engineer at Pfizer Belgium. In this webinar, she explains how Pfizer has adopted Enzyme Indicator (EI) technology for its VHP bio-decontamination procedures. She outlines the differences in EIs compared to more traditional Biological Indicators and the way in which Pfizer utilises the ...
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NewsAnalysis of corticosteroid formulations in metered dose inhalers
The spectrophotometric-based method offers rapid and reliable analysis of formoterol and beclomethasone formulations in metered dose inhalers, according to research.
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NewsEFPIA reaction to European Parliament plenary vote
Following the recent European Parliament plenary vote, EFPIA asserts that aligning the next revision of the pharmaceutical legislation to increase Europe’s competitiveness will be a challenge.
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NewsNew partnership to aid supply of Ga-68-based radiopharmaceuticals
The new collaboration is set to ensure a steady, more accessible supply of Ga-68-based radiopharmaceuticals, thereby helping to address traditional logistical challenges due to gallium’s short half-life.
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NewsStrong growth for Sweden’s pharmaceutical exports
A focus on innovation and high quality is helping Sweden to strengthen its position as a key player in the global life sciences market, SwedenBIO states.
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NewsLonza to acquire major biologics manufacturing facility
The new acquisition is set to boost Lonza’s large-scale biologics manufacturing capacity for mammalian therapeutics.
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NewsSandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
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NewsMedical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
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NewsNew antibody drug formulation wins novel MHRA approval
A new formulation of an antibody drug has been authorised via a process from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables “considerably shorter” approval timelines.
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ArticleForward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control with high-performance analytical instrumentation
Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).
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Article2024 Pharmaceutical industry trends - discover the latest pharma quality and manufacturing trends
Some of the most sought-after human experiences are health and happiness. Although pharmaceutical companies cannot determine personal happiness, they are working to improve personal health outcomes that can tip the scale. The demand for personalised medicines, cell and gene therapies, hyperresponsive and patient-centric healthcare, real-world data fuelled by artificial intelligence ...