industry. Its expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO,[…]

new formulations in humans. In this presentation, Vanessa Zann will describe how the application of Quotient Sciences’ Translational Pharmaceutics to re-engineer this process has created a Rapid Formulation Development and Clinical Testing approach, using clinical data to improve decision-making and halve development timelines using case studies from over 300 delivered programs.     DCAT 2025[…]

lines leverage high-performance chromatography, a gold-standard technology for producing efficient, high-quality cytotoxics. Clients also benefit from Axplora’s best-in-class payload-linker development laboratories, bioconjugation suites and drug product release testing, enabling seamless transition from early clinical phases to commercial production—all with a single team of experts guiding the process to de-risk supply chains. This integrated approach[…]

limitation, manufacturing strategies must incorporate automation and digital transformation. Integrated automation systems aim to replace human-dependent processes with robotics and AI to manage raw materials, drug product testing , and all associated processing equipment. The Pharma 4.0 (4) framework provides a roadmap for creating interconnected manufacturing architectures. This transition requires drug developers and contract development[…]

21 were biologics (3). As FDA and the U.S. congress have taken steps to simplify the categorization of biosimilars in the US (4) by eliminating the interchangeability testing requirements, biologic drug sponsors may face steep competition as downward pricing pressures increase.   In a recent study seventy-seven percent of respondents said their organization views digital[…]

very debilitating. It makes you feel like you have no energy or strength, and there are no treatments out there to help manage your symptoms. I believe you need to look after yourself and the BOOST trial is testing something simple and safe that may improve the quality of life of people with advanced cirrhosis.”[…]

sponsored by AAK and curated by the Green Chemist Consultancy, explores novel approaches to sustainable sourcing, eco-friendly formulations, and sustainable certifications. On the final day, the new Testing and Regulatory Forum will address the latest updates in compliance, efficacy testing, and regulatory updates.   Marketing Trends This year’s marketing trends presentations will provide the[…]

jobs to the Raleigh-Durham area over the next three years and is being rolled out in two phases: Phase 1: A 20,000-square-foot space for cGMP release testing —featuring cell-based potency and molecular assays—operational immediately. Phase 2: An additional 30,000 square feet expected to open in July 2025, offering expanded capabilities for stability testing and[…]

White Lab, an Italian analysis laboratory group focused on the testing and consulting services sector, will attend the Arab Health 2025, the leading international trade fair for medical device industry, held in Dubai from 29 January to 1 February. Participating in this event for the second year in a row consolidates the company’s role in[…]

cost-effective solution for various concepting and development stages and initial small-batch production. At a time when many pharma manufacturers have faced challenges finding blister units for stability testing, clinical trials and small batch runs that aren’t onerously expensive and unnecessarily lengthy or bulky, the modestly priced Eagle-LP measures just 1.8 meters in both length[…]

This global infrastructure allows IMCD to collaborate closely with customers in spaces operating as innovation incubators for co-creation of bespoke formulation development, and providing them with cutting-edge testing capabilities, and advanced product prototyping. The result is faster time-to-market for new beauty products, backed by robust technical and regulatory expertise. Centre of Excellence for[…]

phase your project is at and the current timelines. Be clear about the known current risks that may impact on project timelines, such as raw material supply, testing queues if using external laboratories, regulatory approval, etc. Have mitigation actions for each of these risks been identified and assessed? Consider your forecast and strategy for when[…]

cell model systems, such as three-dimensional (3D) cultures which serve as valuable tools for new conjugates evaluation, with the added potential of using patient-derived cells for NAT testing .   Conjugation Components The optimal antibody being conjugated to the active chemical moieties should have relatively efficient internalization, tolerable immunogenicity and satisfying plasma half-life. However, too[…]

stream refining from the beginning of the research process allows refiners to lend their expertise and support the creation of optimal, cost-saving waste streams. By sampling and testing a typical waste stream, they can help identify the most cost-effective in-process and post-process refining solution based on a customer’s unique needs. If needed, they can also[…]

offer formulation development, manufacturing, packaging, labeling and distribution in a variety of oral & injectable dosage forms and filling formats. Our comprehensive analytical method development, validation and testing platform supports TIDES drug development from discovery through clinical to commercial for both drug substance and drug product. Moreover, our regulatory dossier preparation teams are experienced in[…]

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[…]