10.22.25 -- What Changes To FDA And CBER Mean For The Future Of CGT With Daniela Drago

Explore facility cleaning, monitoring, and disinfection strategies to meet regulatory standards, emphasizing planning, stakeholder involvement, testing, trending, documentation, and continuous improvement.

CGT regulations are rapidly evolving. With hundreds of therapies in development, scalable automation and smarter systems are essential to meet compliance, reduce complexity, and protect patient lives.

Scaling production demands both flexibility and strict compliance. See how innovators can rethink strategies and streamline processes to meet demand without compromising patient safety or regulatory standards.

View often overlooked contamination sources, like residues, poor housekeeping, and training gaps, which offer practical, actionable strategies to strengthen and optimize your contamination control program.

The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

Discover how Raman spectroscopy and parallel bioprocessing enable real-time cell culture monitoring, saving time and providing crucial data for process optimization in biopharmaceutical production.

Laboratories drive innovation, but their environmental impact is growing. Learn five practical tips to make your lab more sustainable to reduce waste, and support global climate goals.

New EU rules tighten grip on contamination control for sterile drugs. Ensure your cleaning and disinfection meet the stricter standards to proactively identify, evaluate, and control contamination risks.

Generic, off-the-shelf media can introduce hidden costs and delays in cell and gene therapy development. A strategic media approach is a critical advantage that can accelerate your path to the clinic.

Become fully equipped with the essential tools and strategies needed to strengthen your calibration efforts and better position your organization for success in regulatory audits.

Assimilate more about the key features of a high-quality recombinant trypsin and how it can benefit your bioprocess with insightful answers to these common questions.