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Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceuticalmanufacturing, the addition of AI technologies introduce a paradigm shift. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.
September 2023 saw a wave of new pharmaceuticalmanufacturing facility expansions and launches across Europe. Importantly, each site features advanced technologies to support development and manufacture of these therapeutics. Materials and financing costs are high and squeezing manufacturers and their customers alike.
According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceuticalmanufacturing in the EEA, is implemented.
explained that “accurate determination of nitrite content in process water will support an understanding of the potential for nitrosamine formation from nitrite in process water for a given API or drug product manufacturing process”. Kumar et al. Main results from the chromatography study Samples from a range of continents were tested.
Pharmaceutical Technology spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceuticalmanufacturing.
A deep carbon footprint is a common hallmark of energy intensive manufacturing processes – and the manufacture of pharmaceuticals is no exception. For many pharmaceutical companies, with complex, multinational operations, the challenge is devising a net-zero roadmap that is both effective and sustainable.
To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. The result is efficient, cost-effective and high-quality (bio)pharmaceutical production.
New regulations, including those put forth by Annex 1, require many pharmaceuticalmanufacturers to rethink their facility designs to promote compliance.
It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceuticalmanufacturing. Now, Dr. | It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceuticalmanufacturing.
billion and another 200 new jobs is planned for Eli Lilly and Company’s two new pharmaceuticalmanufacturing sites in Boone County, US. Eli Lilly’s investment here is the largest manufacturing investment at a single location in its history. Students will also be able to access a smart manufacturing lab.
The International Federation of PharmaceuticalManufacturers and Associations (IFPMA) has unveiled the upcoming lineup for its CEO leadership team over the next two years. A new triumvirate of biopharma bigwigs is in line to reign over one of the industry’s top trade groups. |
The Association of the British Pharmaceutical Industry (ABPI) has drawn attention to a new report , which has emphasised the importance of UK advanced manufacturing requiring a long-term strategy to ensure its continued success. Article: Are we globally prepared for the next pandemic?
The first industrial-scale pharmaceuticalmanufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. During the earlier announcement for its French facility, Orano Med highlighted one key challenge of developing lead-212 based radioligand therapies is manufacturing then on an industrial scale.
This step is important as these countries are key markets for pharmaceuticalsmanufacturing. A more sustainable manufacturing future Ultimately, the standard aims to improve transparency and supporting the assessment and reduction of the environmental impact of medicines across their manufacture, supply, use and end of product life.
Drastic steps need to be taken if the UK is to reverse a steep decline in medicines manufacturing in recent years, according to a cross-industry coalition. Since 2010, the UK has fallen from 4th to 98th place in overall trade balance in pharmaceuticals, due to fierce global competition, according to the MMIP. It’s not all bad news.
43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for PharmaceuticalManufacturing. According the PDA, the standardised quality criteria in TR 43 are intended as a guidance overview for container manufacturers and for incoming container acceptance inspection at pharmaceutical companies.
This programme was developed by the British Standards Institute (BSI) to verify companies that are taking the necessary steps in ensuring responsible antibiotic manufacturing in the global supply chain, helping to lower the spread of AMR.
Novo Nordisk has announced plans to invest over 42 billion Danish kroner (nearly £5 billion) starting in 2023, to expand its manufacturing facilities in Kalundborg, Denmark. According to the pharma company , the financing will add to global capacity: from manufacturing of active pharmaceutical ingredients (API) through to packaging.
Sanofi has signed definitive agreements with Adragos Pharmaceutical, a German contract development and manufacturing organisation (CDMO), for the sale of its pharmaceuticalmanufacturing site in Kawagoe, Japan. The French pharmaceutical company will also enter into a long-term supply agreement with the CDMO.
Contract research, development and manufacturing organisation (CRDMO) WuXi STA has broken ground on its new 190-acre pharmaceuticalmanufacturing campus in Middletown, Delaware, US. WuXi STA has 12 sites across the US, Europe and Asia. This campus is only possible because of Delaware’s world-class, innovative workforce.
The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. Globally, the pharmaceutical sector emitted around 52 megatonnes of CO 2 in 2015, the most recent period for which detailed numbers are available.
There has been a steady stream of developments in the vaccine manufacturing space throughout 2023. A notable milestone was Moderna’s announcement in April that it had, following finalisation of a ten-year strategic partnership with the UK Government, commenced construction of its mRNA vaccine manufacturing technology centre.
million to establish a Medicines Manufacturing Skills Centre of Excellence. Enhancing talent in pharmaceuticalmanufacturing “Talent and skills are fundamental to successful innovation and industry growth. The UK government is investing £5.5
A new global Minimized Risk of Antimicrobial Resistance (AMR) certification has been launched to promote and demonstrate responsible antibiotic manufacturing in the global pharmaceutical supply chain. BSI, a UK standards body, developed the new certification to the Antibiotic Manufacturing Standard published in June 2022.
In the interview, conducted at CPHI Barcelona, Krishna Venkatesh, Global Head, Sterile Manufacturing Operations at Dr Reddy’s Laboratories explores industry’s growing focus on achieving end-to-end connectivity, as well as the potential of automation and track and trace solutions. KV : We have seen two specific elements.
[pharmaceutical companies] must take measures to manage antibiotic waste across the manufacturing supply chain” 2023 has so far, delivered a spectrum of change for antibiotic manufacturers across the pharmaceutical industry, from supply chain issues through to regulatory opportunities.
The manufacturing site will be completed in three phases and will produce anti-bacterial medicines and anti-malarial drugs. Fosun Pharma chairman Wu Yifang stated: “We are glad to be supported by IFC to localise pharmaceuticalmanufacturing and distribution in Africa.
Also, the [limit of detection] LOD and [limit of quantification] LOQ values achieved in this study are well within the acceptable ranges for pharmaceutical analysis, ensuring that even trace amounts of Impurity C and N-formyl carvedilol can be reliably detected and quantified, Yuan et al.
QMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
APL Health Care (Aurobindo )-Openings for Manufacturing / Packing Department- Apply Now Job Description Company Profile: Aurobindo Pharma Ltd’ (APL). APL is a growing India multinational pharmaceuticalmanufacturing firm with turnover of over US$2.8 Greetings from Aurobindo !!!
The growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.
Tumble blenders deliver highly accurate and repeatable mixing of powders, granules and even low-viscosity slurries. In addition, this style blender enables complete discharge and easy cleaning.
The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. In other words, money over safety. Can patients really be confident in pharma supply chains?
A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.
The first in our inaugural Pharma Horizons report series is dedicated to exploring the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceuticalmanufacturing and quality control. Additionally the pharmaceutical AI market is projected to reach $11.8
A paper has demonstrated a novel application of optimising processes to implement inverse design in pharmaceuticalmanufacturing. Machine learning techniques were assessed for use as a surrogate model to optimise a three-unit wet-granulation based flowsheet model for the manufacture of solid dosage forms. Dan et al.
This “operational technology” (OT) is critical for pharmaceuticalmanufacturing and R&D organizations. Today’s factory floors include production equipment that’s linked directly into those IT systems that are so often the victims of a cyberattack.
International companies investing in the emerging market of Brazilian pharmaceuticalmanufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.
Currently, validation of cleaning processes for pharmaceuticalmanufacturing equipment is done using analytical methods such as swab or rinse and subsequence laboratory testing. However, although FTIR has proven to be effective, it must be robust to be used in a Good Manufacturing Practice (GMP) manufacturing facility.
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