Navigating industry challenges in the development and commercialization of advanced therapy products
Leverage an experienced, fully integrated CDMO partner with robust global network to address your unique project needs
Due to their unique and complex nature, the development of novel advanced therapeutics often requires charting your own path and navigating through many unknown circumstances along the way. At Thermo Fisher Scientific, we focus on understanding the unique needs of your advanced therapy so that we can innovate tailored solutions to meet them. Explore our resources below for guidance on addressing common challenges in the development and commercialization of advanced therapies, including regulatory, manufacturing, and supply chain considerations.
eBook: Cell and gene therapies in the US vs. the EU
For cell and gene therapies, US and EU regulatory processes vary by more than just jurisdictional oversight. Here we share guidance for companies hoping to gain market access through FDA or EMA approval, 5 key differences in the drug development process and review, and top tips for navigating these differences.
On-demand webinar: Key considerations to optimize performance and mitigate risk in plasmid DNA manufacturing
This on-demand webinar provides an in-depth overview of common challenges facing advanced therapy developers using pDNA, as well as strategies to mitigate risk and achieve both cost and quality goals in plasmid manufacturing.
Article: Addressing challenges in mRNA drug development and manufacturing
mRNA is being explored as a therapeutic strategy for various clinical applications, but despite its inherent advantages, several challenges still exist from optimizing stability and protein expression, to developing robust production and purification processes. Read this article for tips on navigating these challenges and positioning your mRNA product for success.
Infographic: mRNA manufacturing workflow
Like many therapeutic manufacturing workflows, every step in the mRNA process builds upon the prior step. This infographic explores each intertwined step in the mRNA manufacturing process and outlines how Thermo Fisher Scientific’s flexible approach can get your mRNA product to clinic and market faster.
On-demand webinar: Next-generation analytics in viral vector manufacturing
This on-demand webinar provides information on the role of analytics in the production of viral vectors for gene therapies and gene-modified cell therapies, current challenges related to traditional analytical methods for determining viral vector quality and characterization, and real-life case studies demonstrating process improvement.
Article: Product partnership quality in viral vector manufacturing: Your gene therapy depends on it
Realizing the potential of gene therapy requires overcoming challenges, notably development of safe and effective delivery systems, such as viral vectors, to transport therapeutic genetic material. The complexity of viral vector production underscores the importance of prioritizing quality in the vectors and CDMO partnership for efficient, safe, and scalable gene therapy development.
Whitepaper: Key considerations for labeling your cell and gene therapy
With the growing complexity of today’s drug products, ensuring safe delivery to patients is increasingly challenging. Sponsors must secure supply chains aligned with commercial goals and employ robust packaging and labeling strategies. Discover key factors for labeling cryogenically stored cell and gene therapies, preventing costly issues during clinical trials.
Article: Prepping for commercialization through supply chain logistics
With the rapid growth of cell and gene therapies, the need for dependable supply chain solutions to deliver effective treatments to waiting patients intensifies. This article outlines key industry challenges as sponsors prepare for commercialization including ultra-low temperature control, management of stringent timelines, documentation and tracking requirements, and scale-up capabilities.
