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Advanced Analytics Delivers Continuous Manufacturing InnovationAdvanced analytics streamlines continuous manufacturing by providing improved insights to data.
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Executive Summary: Leveraging the Evolving Bioequivalence Regulatory Landscape to Enhance Inhaled Product Design and DevelopmentThe regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality.
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Addressing Developmental Challenges of Gene Therapy Viral VectorsSignificant improvements have been developed to tackle the challenges in viral vector manufacturing at each stage.
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Addressing Developmental Challenges of Gene Therapy Viral VectorsSignificant improvements have been developed to tackle the challenges in viral vector manufacturing at each stage.
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Approaches to Alleviating Subcutaneous Injection-Site Pain for Citrate FormulationsThe authors compare formulations containing citrate with other buffers in reducing subcutaneous injection-site pain and discuss a formulation and excipients selection strategy.
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USP Novel Excipients Survey: Stakeholders’ Views on the Current State of Excipient InnovationSurvey results indicate that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients.
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USP Novel Excipients Survey: Stakeholders’ Views on the Current State of Excipient InnovationSurvey results indicate that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients.
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USP Novel Excipients Survey: Stakeholders’ Views on the Current State of Excipient InnovationSurvey results indicate that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients.
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The Value of Pharmacopeial Reference StandardsThis article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.
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USP Novel Excipients Survey: Stakeholders’ Views on the Current State of Excipient InnovationSurvey results indicate that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients.
