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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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Webinar Date/Time: Wed, Dec 4, 2024 11:00 AM EST

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Despite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.

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AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

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At Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology and the latest trends in the industry.

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Within several sites available for pharmaceutical contract manufacturing, WeylChem has access to many technologies, e.g. low temperature, halogenations, or complex metalloorganic chemistry. This allows us to offer our customers a reliable, transparent supply chain.

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The US Pharmacopeia recently convened a meeting of stakeholders to set goals for its 2010–2015 cycle.

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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as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

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The combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.

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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.