10.28.25 -- Why The First Mile Is Critical To CGT Success

In 2025, CMOs are navigating Annex 1 compliance, the BioSecure Act’s uncertainty, AI-driven drug development, supply chain challenges from tariffs, and pandemic preparedness strategies.

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

Automated visual inspection (AVI) combines robotics, precision imaging, and sophisticated defect-recognition software to provide a scalable solution for expanding pipelines.

The greatest challenge in drug development can be finding a team capable of carrying a molecule through the complexities that lie between the research lab and the patient’s bedside.

Explore how advanced machine learning and data analytics are revolutionizing biopharmaceutical manufacturing and driving operational excellence.

Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

Discover how surging demand for GLP-1 and other therapeutics is transforming fill/finish capacity and regulatory standards. Learn how CDMOs are adapting to the complex needs of emerging modalities.

Explore the benefits of the XS® Pichia 2.0, including speed, simple fermentation regimes, and robust, scalable processes that can be tuned according to the specific objectives of a program.

Adopt next-generation, physiologic T cell activation strategies to enable faster, more consistent, and scalable CAR-T manufacturing that improves expansion, persistence, and patient access.

Standardized methods, materials, and analytics are critical for overcoming hurdles in the gene therapy space. Explore how a platform approach to fast-track AAVs can enhance quality and efficiency.

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

Biopharmaceutical supply chain volatility is at an all-time high. To navigate this complexity, CDMOs must prioritize robust sourcing strategies and proactive vendor management.