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The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.

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The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.

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The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.

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Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.

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X-ray powder diffraction exploits the interaction between x-rays and matter to study the structural and microstructural properties of materials.

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As Europe's growing biomanufacturing and bioprocessing industries develop, now a crucial time for the small-molecule and biopharma industries to integrate in order to facilitate growth.

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The authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).

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Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.

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This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.

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Advanced analytics can extract enormous value from your LIMS. Find out how LabVantage Analytics solves the challenges of data access, visibility, volume, and speed for complete data views and endless insights.

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Thursday, August 26, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST This webcast will explore the benchmark practices for rapid progression from first-in-human to large-scale commercial manufacture for microdosing API. Micro-dosing at a commercial scale made effortless.

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This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.

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This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.

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An architect's evaluation early in a pharmaceutical facility relocation and design process can help identify potential problems.

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Preventing contamination during routine cleaning operations requires particle-free cleaning equipment to maintain specific airborne particle levels.

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The identification, characterization, and quantitation of host cell protein (HCP) impurities are a critical challenge in the biopharmaceutical industry. Advanced LC-MS techniques can be integrated into manufacturing workflows to mitigate risks and ensure higher product quality and improved patient safety.

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Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.

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This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.

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This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.

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This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.

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This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.

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Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.

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Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.

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Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.

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Manufacturers are facing ever-increasing competition while end users are expecting better value and efficacy. The authors discuss these challenges and offer practical solutions.