ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Optimizing qPCR For Broad-Range Transcript Detection In Anti-PD-1 Therapy

  Optimize qPCR protocols for greater sensitivity and reproducibility to accurately measure immune-related gene expression and better identify patients who will benefit from anti-PD-1 immunotherapy.

• The Sponsor's Clinical Development Handbook For Gene Therapy Trials

  Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.

• Phase-Appropriate Approaches To Manufacturing And Testing

  Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

• Building Bioanalysis Infrastructure For Modern Drug Development

  Drug development accelerates with AI, decentralized trials, and adaptive protocols, but legacy CRO infrastructure lags. Platform-based systems enable speed, quality, automation, and continuous improvement.

• Outsourcing RNA-LNP Production: A Key To Competitive Success

  Manufacturing RNA-containing LNPs demands specialized expertise. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.

• How To Unlock The Secret To Repeatable, Scalable Low Turnover

  Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

• When Is A New Biologic Ready For GMP Production?

  While there are differences by modality in DNA, RNA, and protein, find general recommendations on questions to prepare for and steps to consider when preparing to move to clinic.