News in Depth

Advancements in synthesis and analysis technologies are helping unleash the therapeutic potential of peptides and oligonucleotides, spurring the dialogue on how the CMC/quality regulatory expectations, guidance and standards should keep pace.

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In May 2020, the USP Convention (USPC) met virtually to review how its central role in advancing public health has evolved during the broad sweep of its 200-year history on the one hand, while assessing its response to the pressing needs of the COVID-19 crisis now dominating the healthcare field on the other.

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The urgency of delivering a vaccine for COVID-19 in previously unattainable timeframes and volumes is throwing the spotlight on the expanded role next-generation sequencing (NGS) needs to play to avoid the time delays and other limitations of in vivo/animal testing.

PART II: Sanofi Pasteur and Ghent University Experience with NGS [CLICK HERE]

PART III: A Decade of Regulator/Industry Collaboration on NGS [CLICK HERE]

PART IV: Stakeholder Engagement Begins on ICH Q5A Revision [CLICK HERE]

PART V: Effort to Reduce Animal Testing for Vaccines Includes Global Health Fund Support for NGS [CLICK HERE]

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The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is partnering with the industry consortium BioPhorum to develop a more streamlined, cost-effective, and resource-conserving way of addressing the buffers used in biopharmaceutical manufacturing.

Over-the-counter (OTC) drugs – from raw material supply through product manufacturing and distribution – remained a central concern at the FDA Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) during 2019.

Initiatives that the major regulatory agencies have been advancing to help address the CMC and technology challenges of developing complex medicines under accelerated timelines are creating a critical foundation for responding to the current coronavirus pandemic.

IPQ’s five part series is exploring the need for: ● a more qualified-for-purpose excipient toolbox that can help address the formulation, quality, and manufacturing challenges posed by a new generation of medicines, and ● a regulatory process that can better accommodate novel excipients.

INTRODUCTION

PART I: FDA’S Novel Excipient Program Proposal and Stakeholder Comments

PART II: IPEC/IQ Thought Leaders on the Novel Excipient Drivers

PART III: Subcutaneous Biotherapeutics, Pediatrics, and Delayed Release

PART IV: USP Initiatives Supporting Novel Excipient Development

PART V: Assessing and Managing Excipient Risks