Current State of Oligonucleotide Therapeutics

About the Author

Principal Scientist

ASO Process Development and Manufacturing

Xianglin Shi, PhD, is Principal Scientist, ASO Process Development and Manufacturing at Biogen. Xianglin received a BS in chemistry from Yanan University and an MS...

Charles C. Tong, PhD

Executive Vice President and Head of the R&D

Suzhou Ribo Life Science Co., Ltd.

Charles C. Tong, PhD, is Executive Vice President and Head of the R&D Center at Suzhou Ribo Life Science and is engaged in oligonucleotide drug...

Technical

Risk- And Science-Based Media and Buffer Mixing Validations

1 March 2024

The validation of media and buffer mixing is a continuing area of resource constraint in the pharmaceutical industry. These validations require materials, validation associates’ time, and the use of equipment and processing areas. This article proposes a risk-based life cycle for minimizing mixing validation resource inputs, with the objective of optimizing validation efforts through the use...

Features

Digital Display Labeling in Clinical Supplies for Clinical Trials

1 March 2024

Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...

Features

Evolving China’s Regulatory System in Alignment with ICH

1 March 2024

With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...

About the Author

Facilities of the Future: Meeting the Demands of Breakthrough Therapeutics

Emerging Leader Hacker to GAMPer in 10 Weeks

New Initiative Seeks to Back up ICHs Harmonization Mission

Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future

Q&A with ISPE Foundation Professional Development Grant Recipient Silas Tamufor

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