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Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.

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The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.

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This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

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This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.

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FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.

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Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

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Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient.

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Partnering with a CDMO with collective insights and capabilities to support the development and manufacture of an innovative biotherapeutic program is an essential first step to providing better care to patients.

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Capturing the nuances of immune cell phenotype and function can be achieved using glycosylation analysis.

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This technical note explores the sources of error in gravimetric measurements used for aerosol photometer calibration, emphasizing the impact of discrepancies in aerosol properties, temporal instability, and flawed experimental procedures. It supports the two-point calibration practice to minimize errors, particularly at lower concentrations, and recommends measures such as improved aerosol systems and automation to enhance calibration accuracy. The findings aim to ensure reliable photometer performance for critical applications.

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New enzymes and protein engineering have advanced biocatalysis processing toward commercial acceptance. Technology and economic roadblocks must be overcome for the process to be widely embraced by pharma.

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The authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.

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Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.

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Emerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.

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The NP-RD10A is the leader in analytical, single-station benchtop tablet presses, it’s perfect for laboratory research and development. Control of tablet thickness, hardness, and weight, save time curating mountains of data from just one tablet.

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Increased use of nested and ready-to-use primary packaging has resulted in a need for more validation data on container-closure integrity. This article describes efforts to develop these data for new and traditional containers and closures.

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Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.

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Pharmaceutical Technology Europe spoke with experts about the developments that have shaped the nanotechnology industry today and the benefits that this technology has to offer the pharmaceutical industry, which remain largely untapped.

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Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.

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Any responsible business or industry takes quality seriously. It’s crucial to customer safety and satisfaction, and its prioritization in the development of healthcare products and services – especially pharmaceuticals – is obviously even more so. Nonetheless, it can be easy in development for smaller teams and companies to overlook some components of Quality, despite governmental requirements around complex quality initiatives. Those concerns are well-founded.

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An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

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Standardization is needed in CAR-T cell therapy development due to its inherent complexity.

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A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.

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Focus on the contribution of modified release technologies

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A changing regulatory environment is on the horizon for excipient suppliers and users.

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Recombinant microbial whole-cell biocatalysis is a valuable approach for producing enantiomerically pure intermediates. The authors examine several groups of enzymes using this approach: dehydrogenases, hydantoinases, and acylases.

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Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.

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Rapid market growth in biologics is helping the packaging market expand as well, but the complex nature of biologics and the desire for personalized therapies present unique hurdles to make packaging solutions cost-effective and safe for patients.