specialty chemicals, pharmaceuticals, consumer chemicals, and chemical recycling activities. Released in March 2024, the SBTi draft sector guidance was under consultation until July 15, 2024, with pilot testing now taking place where companies can apply to voluntarily pilot the implementation of the draft chemicals sector guidance. This guidance includes 1.5°C-aligned emissions intensity convergence pathways[…]

under GMP conditions, or buffer preparation can be provided as a service for biopharma customers. These types of service also include batch selection and additional analytical testing to ensure incoming raw materials meet all specified parameters prior to receipt, again reducing the risk of out of specification (OOS) raw materials and production interruptions. This[…]

of EU regulation is the 2006 guidance EMEA/CHMP/SWP/4447/00 followed by Q&A EMA/CHMP/SWP/44609/2010-2011. The guidance describes a tiered approach starting from a pre-screening approach up to an extended testing phase and a full Environmental Risk Assessment. In all cases the ERA assessment must be prepared with robust scientific data generated by experimental studies carried out[…]

benefiting patients as well as the industry. But more importantly, the 80% are also hurting the backbone of the pharmaceutical industry, trust. When you are dealing with testing of new medical treatments, you need to have trust between the patients and the industry. And delayed or even cancelled clinical trials are slowly but steadily erupting[…]

and strokes could reduce the economic burden on health care system in reducing hospitalisations and emergency care costs. According to estimate calculations, optimising treatment based on genetic testing can save up to $3,000 annually (7). Oncology is another major area that is being revolutionised by personalised medicine (8). It helps immensely by enabling the[…]

at AI Validation Level V have greater process control. Therefore, stronger system controls must be in place during operation. This can be achieved through regular repeat testing with defined test datasets. Furthermore, the self-regulating mechanism should be reviewed during the validation phase.   Systems at AI Validation Level VI are self-learning systems. It is[…]

experience and expertise, Neuland provides an end-to-end continuum of customized services from early-stage drug development through to commercial manufacturing of complex APIs, including process development, process optimization, analytical testing, and regulatory support. Neuland has three world-class regulatory compliant API manufacturing facilities capable of handling complex chemistry reactions. The company is headquartered in Hyderabad, India and[…]

upstream capabilities. A longstanding leader in medical tubing solutions, the company now offers an array of services supporting customers from early ideation stages through product development, prototyping, testing and full production of catheter-based systems and other tubing-related solutions. This includes an array of precision secondary processes, as well as clean room assembly of Class II[…]

leader, announced today the opening of its Beauty Research Institute in Shanghai, China. The site will serve as a strategic hub to further grow in vivo beauty testing capabilities, applying decision science to enable next-generation beauty ingredients, empower innovation collaboration and enhance speed to market for Lubrizol beauty and personal care customers in the region[…]

interest).   In any case, with the application of BPR, authorization processes became more difficult for many reasons.   Firstly, but not only, many guidelines regarding the testing phases, all along the years, were updated or released as new and became more stringent. In particular, the efficacy tests changed in some way the study protocols[…]

  Development of integrated, continuous biomanufacturing (ICB) processes brings along the challenge of streamlining the acquisition of data that can be used for process monitoring, product quality testing and process control. Manually performing sample acquisition, preparation, and analysis during process and product development on ICB platforms requires time and labor that diverts attention from the[…]

biomanufacturing process development: facilitating the shift from batch to continuous manufacturing. Curr Opin Chem Eng. 2018;22(October):115-127. doi:10.1016/j.coche.2018.09.008. Jiang M, et al. Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing. Biotechnol Bioeng. 2017;114(11):2445-2456. doi:10.1002/bit.26383. Wasalathanthri DP, et al. Technology Outlook for Real Time Quality Attribute and Process Parameter Monitoring in Biopharmaceutical Development – A[…]

product is not mechanically sensitive as it neither had a positive result in the BAM (Bundesanstalt für Materialforschung und -prüfung / Federal Office for Materials Research and Testing) fall hammer test with a drop weight of 10 kg falling from 40 cm height onto the sample (equal to 40 J impact energy as upper[…]

author with editor at a New York City, NY location April 30, 2024 Gore Mountain, NY website – (https://goremountain.com/the-mountain/trail-maps/) Accessed May 31, 2024 NIST ARIA program (https://www.nist.gov/news-events/news/2024/05/nist-launches-aria-new-program-advance-sociotechnical- testing-and Accessed May 31, 2024 European Parliament AI Act (https://www.europarl.europa.eu/topics/en/article/20230601STO93804/eu-ai-act-first-regulation-on-artificial-intelligence) Accessed May 31, 2024   ABOUT THE AUTHOR Howard J. Stamato has over 30 years of[…]

that also binds to the opioid receptor, the researchers synthesized and evaluated 10 compounds with chemistry that might enable passage through the blood-brain barrier. During their initial testing in cells, they identified the most promising candidate derived from fentanyl, called RO76. By capturing molecules in proximity of the activated receptor, the team showed that RO76[…]

include a free-to-attend Plenary Session and a mix of keynote and break-out sessions. These presentations will cover topics like cutting-edge technologies, formulation development, clinical dermatology, efficacy evaluation and testing, regulations, as well as market trends, offering participants rich academic content and valuable insights into the latest industry trends and developments. Spirit: Inspiring Excellence and[…]

information about side effects over several months or years. While larger than earlier phases, phase II still doesn’t demonstrate overall safety; in Phase III, randomized and blind testing occurs in large groups of people. The focus is on confirming effectiveness, monitoring side effects, and comparing the new treatment to existing ones. Data collected during this[…]

Aurélien Thomen, CAMECA’s NanoSIMS commercial speech Advances in Subcellular measurements of oligonucleotides and peptides with the CAMECA NanoSIMS There is increasing interest in moving away from animal testing and moving towards human organoids. However, oligonucleotides are difficult to measure in vitro with conventional mass spectrometry. This is partly due to that fact that these molecules[…]

major delays at later stages as well as ensure manufacturing consistency. Immunogenicity risk: assays in this group will identify any potential immune responses against biotherapeutics. Immunogenicity testing is absolutely essential because immune responses against a therapeutic can range from antibody responses with no apparent clinical manifestations to life-threatening and catastrophic reactions.   Next,[…]

the years, the regulatory landscape has evolved to accommodate the unique characteristics of nucleic acid therapies. However, navigating this evolving regulatory landscape remains complex, requiring rigorous preclinical testing, robust clinical trials, and close collaboration between industry stakeholders and regulatory authorities. Despite the challenges, as of 2023, 18 nucleic acid therapies have made it to[…]

the need of repeated administration in gene-based therapies, reinforces the importance of biodegradability for the design of gene-delivery vectors. Nevertheless, there is a lack of standardized biodegradation testing methods (5), especially for polymers characterization, which could reasonably rely on libraries of existing biodegradation studies of polymers in a near future. Both naturally-derived and synthetic polymers[…]

techniques.     Leak Detection Capabilities Also at ACHEMA, Antares Vision Group will emphasize its prowess in leak detection. For example, the company’s container closure integrity testing (CCIT) plays a critical role in maintaining the sterility and stability of sterile products, and is essential for preserving critical headspace gas conditions – including those common[…]

based on counterparty type, emphasizing direct collaboration with a network of entrepreneurs or advisors. Galvain focuses on projecting good faith and transparency, with advisors involved for valuation testing. Fitzharris emphasizes collaboration and value creation, leveraging due diligence to address potential obstacles early in the process. Ledbetter stresses the value of transparency and communication in[…]

$74 billion by 2030 (2).   The first biosimilar was approved in Europe in 2006 and, while uptake and savings did not initially meet expectations, manufacturing and testing of biosimilars has improved over time. What seemed impossible in the past – for example, biosimilar monoclonal antibodies – is now considered fairly mainstream. After a[…]

ensure consistent product quality throughout manufacturing processes (1, 2). A parallel effort is echoed by the European Medicines Agency (EMA), which has issued recommendations on real-time release testing (3). As a result, the biopharmaceutical industry is placing significant emphasis on the development of process monitoring and automated process control strategies. One notable approach, proposed by[…]

and encourage the implementation of more efficient approaches in pharmaceutical development, manufacturing and quality assurance (1). The aim is to build quality into the products instead of testing the quality of the product at the end of the process, thus introducing the principle of Quality by Design (QbD) – a science-driven, risk-based approach supported also[…]

replace of experimental approach with alternative methods (at least for some toxicological end-points) is not expected soon (see 1). This means that companies will continue to pay testing labs to get their own studies. The results of such studies are not public but covered by confidentiality for a number of years (12 under the REACH[…]

new medicines for the treatment of diseases is not a simple task. Researchers often create new active compounds from scratch, through a laborious process involving synthesising and testing thousands of compounds with the aim of finding those suitable to be tested in human beings (1). In this context, medicinal chemistry is an interdisciplinary science at[…]

KAISERAUGST, Switzerland, May 6, 2024 – Solvias announced today that it is expanding its global network of laboratory testing centers with a new biotech site in Research Triangle Park, N.C. It is the company’s latest investment to expand its analytical testing services supporting life science organizations with the growing number of cell and gene therapies[…]

Adstiladrin® (nadofaragene firadenovec-vncg) for ensuring long-term future supply. Following technology transfer, SK pharmteco, a contract development manufacturing organisation (CDMO), will be qualified as another source for manufacturing, testing, and release of the medicine, subject to regulatory approval by the U.S. Food and Drug Administration (FDA). Adstiladrin® was approved by the FDA in December 2022 for[…]

in Türkiye last November.   iCare is an innovative one-stop digital portal providing textile manufacturers with a pioneering solution that enables seamless management and monitoring of their testing processes from start to finish. Harnessing Intertek’s unique Science-based Customer Excellence Advantage, iCare addresses the long-standing challenges of transparency and traceability in the processing and testing of[…]

revolutionary SymSave® H, sees Symrise broaden its formulator toolbox. While enabling the formulation of safer products, Savelite® HB acts as an efficient moisturizer. in vivo corneometer testing show an increase of 10.9% after two weeks. It fully respects the skin microbiome. Further, it can help stabilize emulsions by reducing oil droplet size. The ingredient[…]

which is to enable companies of all sizes to ensure reliable assessment of sun protection, in accordance with international standards. Thus, we have moved from a testing laboratory to a complete and unified center of expertise, bringing together all the services and products relating to the evaluation of sun protection using alternative methods. […]

challenges arise from retailers, consumers, and NGOs urging the removal of non-easily substitutable ingredients, including preservatives, colorants, and chelating agents. A notable obstacle is the constraint on testing , especially as the industry grapples with innovation amidst bans on animal testing and the absence of adequate alternatives. There’s an industry-wide push towards sustainability, seeking to[…]

a dose of 4.1E11 total vector genomes. “Children with OTOF-mediated hearing loss are often born with profound hearing loss, yet only a small fraction have undergone genetic testing to receive a definitive diagnosis,” said Dr. Oliver Haag, pediatric otolaryngologist, Head of Otolaryngology at Sant Joan de Deu Hospital in Barcelona, and an investigator in Akouos’s[…]

  AI is an end-to-end solution for small molecule drug discovery combining AI and ML capabilities with Aurigene’s core expertise in synthesizing and testing the molecules in vitro and in vivo. The platform consists of a meticulously curated database that serves as training data. The modular platform allows users flexibility in selecting suitable AI models[…]

a strategic decision to focus on core areas of growth and investment,” said Cambrex CEO Thomas Loewald. “Looking forward, Cambrex will prioritize our drug substance and analytical testing portfolios, enabling our customers to develop and deliver therapeutic solutions for patients around the world.” Cambrex recently expanded its portfolio of specialized solutions for pharmaceutical development and[…]

easily found on the internet, but here are a few pointers and notes.   Belgium’s Health Minister Sparks Debate Over Ozempic Prescription Limitations. Belgium’s Ozempic Controversy: Testing the Bounds of Therapeutic Freedom (bnn.network): Belgium bans use of Ozempic for weight loss until summer. Belgium bans use of Ozempic for weight loss until summer |[…]

Servizi (blocco D, 1° piano); qui troverà spazio anche un’area dedicata a Cosmetica Italia Servizi, società di servizi dell’Associazione che offre supporto professionale, formazione e attività di testing alle aziende. All’interno della lounge di Cosmetica Italia, un’apposita area convegnistica ospiterà nel corso dei quattro giorni della manifestazione una serie di incontri utili ad approfondire temi[…]

scientists presented a road map addressed to practice an animal experimentation that will take into account both the data quality and the welfare of animals used in testing . Their approach is still known as the 3R principles where 3Rs means:   Replacement: “any scientific method employing non sentient material which may, in the history[…]