11.18.25 -- Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads

Enhance AAV gene therapy quality and regulatory compliance with our advanced AEX-based purification platform, achieving >90% full capsid purity — even for oversized AAV8 vectors.

Scientists discuss the issues with current titer measurement methods, describe the Virus Counter Plus platform, and present highlights of a recent study conducted in collaboration with Sartorius.

Discover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

The most complex and expensive drugs to develop often target terrible diseases that affect only a small number of people and will never reach blockbuster status.

Every choice is critical in AAV vector production. Experts share how to make the right choices, from the process and cell line, to off-the-shelf plasmids and qualified analytical methods.

Learn about the development and effective scale-up of a robust process for manufacturing adenovirus vectors and the obstacles that were encountered and successfully overcome.

Consider the potential of allogeneic cell therapies to combine the efficacy of personalized medicine with the scalability, accessibility, and uniformity of traditional off-the-shelf therapeutics.

Ensure cell therapy products are consistently manufactured with safety, quality, and potency, supporting regulatory approval and successful clinical development.

Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Review five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.

Explore the following considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.

Recognizing and integrating diversity, equity, and inclusion (DEI) is essential for fostering innovation, improving team performance, and ensuring long-term competitiveness in a global market.

Better understand why this area is poised to become a leading hub for cell and gene therapy, as highlighted by CCS and industry experts at the 6th Annual Supply Chain Summit.

A unique, scalable, and cost-effective approach to generating AAV viral vectors leverages a high-performing cell line, optimized reagents, and purpose-built technology.

Experience = the difference a dedicated, expert project management team can make in ensuring the success and smooth execution of your cell therapy programs.

Here, we describe how SGS's Hudson facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and seamless global support.

With decades of expertise in logistics and a scalable global infrastructure, we leverage purpose-built facilities and advanced technology to serve as the trusted partner for your BioServices needs.

Accelerate your gene therapy pipeline with our cost-effective, high-quality lentiviral vectors, optimized for clinical and commercial success.

Our flexible partnership models empower you to scale efficiently and confidently — whether advancing a single molecule or managing a complex portfolio of therapeutic candidates.

Leveraging a partner with expertise and integrated, end-to-end solutions can help overcome obstacles to increase patient access and ensure the safe distribution of your advanced therapy product.

Supporting over 15 commercial therapy programs globally, we empower scientists with cutting-edge tools, personalized services, and regulatory support.

Our gene therapy viral vector process development and manufacturing capabilities are designed to confidently and rapidly progress your products from gene to market.