All Raw materials and supply chain (bioprocess) articles – Page 6
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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 ...
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NewsAmgen opens its most advanced manufacturing facility to date
The biomanufacturing facility has been designed to help Amgen meet its target of carbon neutrality in all its operations by 2027, according to the company.
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NewsWHO initiative to enhance biomanufacturing in LMICs
A new World Health Organization (WHO)-driven initiative aims to enhance bioproduction capabilities for biological products in low- and middle-income countries (LMICs).
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NewsBioNTech agrees collaboration to accelerate autologous CAR-T therapies
The collaboration between BioNTech SE and Autolus Therapeutics utilises manufacturing and commercial infrastructure, supporting a shared goal of advancing autologous CAR-T programmes towards potential market authorisation.
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NewsAstraZeneca to boost cell therapy operations with $300m manufacturing investment
Investment in the US manufacturing facility will accelerate AstraZeneca’s ambition to make next-generation cell therapy a reality, the company asserts.
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NewsSuanfarma realigns brand to showcase innovative spirit
The new identity of Suanfarma’s industrial brands signifies integration of its manufacturing sites as part of Suanfarma CDMO.
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NewsUS legislation to benefit small molecule drug innovation
Passing of two key legislations in the US is set to support innovation for small molecule drugs and the biotech sector, Biotechnology Innovation Organization (BIO) asserts.
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Whitepaperebook: 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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NewsRevised 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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WhitepaperWhitepaper: Imaflow® Platinum Silicone Brewing in Coffee Vending
Imaflow® Platinum cured silicone tubing is heat resistant, flexible, and available with colour coded options (NSF-51 Certified for hygiene)
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NewsBoehringer plans €120m European manufacturing expansion
The manufacturing capacity for some of Boehringer Ingelheim’s medicines, in disease areas including mental health and cardio-renal-metabolic conditions, will benefit from the European facility expansion.
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NewsNew collaboration could transform neonatal therapy
With no currently approved medicines for the prevention of bronchopulmonary dysplasia (BPD) in extremely pre-term infants, a new pharmaceutical collaboration could produce the first major therapeutic breakthrough for this patient group in decades.
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NewsExpanded Pluvicto production gets FDA go-ahead
Novartis has obtained US manufacturing authorisation for radioligand therapy PluvictoTM at its largest, state-of-the-art radioligand therapy facility.
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NewsFinancial factors to support and challenge Pharma in 2024
While constraints such as inflation and drug pricing pressures will impact pharma’s growth in 2024, patent expiration of biologics is expected to support the industry over the next few years, research suggests.