Though much of the regulatory filing requirements for mRNA-based therapeutics can be compared with those for traditional biologics, others are not yet well defined. Like traditional biologic products and processes, mRNA-based products require controls on the quality of the starting material (including cell banking), consistency of manufacturing processes, identification of critical process parameters, clearance of impurities, establishment of environmental controls to meet safety requirements, and the thorough characterization of structure, purity, and efficacy. This has posed some challenges in analytical method development to ensure qualification for intended use. We discuss some of these challenges and solutions to support the requirements for characterization of structure, purity, and efficacy of an mRNA Drug Substance.
In vitro transcribed (IVT) mRNA has become an effective and scalable therapeutic modality for a wide range of disease indications. It has been shown that modifications to wild-type uridine may improve the efficacy of these therapeutics. To aid in the synthesis of these compounds, TriLink is developing an extensive platform to manufacture modified uridine and mRNA at both GMP quality and scale.
In this presentation Cory Smith, Application Scientist, TriLink BioTechnologies will discuss in vitro transcribed (IVT) mRNA and how it has become an effective and scalable therapeutic modality for a wide range of disease indications.
In this webinar, Dr. Laura Sepp-Lorenzino Chief Scientific Officer at Intellia, will share the company's progress in both in vivo and ex vivo genome editing approaches. In particular, she will discuss the recent advances made regarding NTLA-2001—the first-ever investigational CRISPR-Cas9 therapy candidate to be systemically delivered for the treatment of ATTR amyloidosis.
In this webinar from GEN and The CRISPR Journal, Professor Dan Peer will discuss the state of RNA-based therapeutics, particularly developing a self-assembled modular platform that enables the construction of a theoretically unlimited repertoire of RNA-targeted carriers. He will present a novel approach for delivering modified mRNA to specific cell types in vivo utilizing this platform.
In recent years, the development of mRNA and its applications has dramatically expanded across therapeutic areas. The clinical development of mRNA products includes a number of unique features and considerations that are rooted in mRNA’s molecular characteristics. In this webinar, May Guo, MBA, Director of Business Development at TriLink BioTechnologies, will highlight important aspects to consider as you develop your mRNA tools and drugs.
Analytical testing is a key component of every mRNA therapeutic program. In this mRNA Basics webinar, Jessica Madigan, Director Business Development, GMP at TriLink, will discuss analytical testing considerations for mRNA and common mistakes to avoid.
In this presentation, Jordana Henderson MS, Scientist at TriLink BioTechnologies will explore the manufacturing benefits of IVT synthesis using CleanCap Cap1 analogs for highly functional mRNA as shown in mice.
More scientists than ever are embracing mRNA technology for vaccine and therapeutic applications. However, the road to GMP manufacturing can be challenging for those new to the field. In this mRNA Basics webinar, Sawan Shah, Sr. Manager, Business Development at TriLink, will cover the key considerations for transitioning your mRNA program to GMP.
mRNA sequence optimization is an important step in the design of mRNA vaccines and therapeutics. In this mRNA Basics webinar, Cory Smith, Senior Technical Inside Sales Specialist at TriLink, will walk through the strategies and resources for coding sequence optimization.
In this webinar, Jessica Madigan, Director of Business Development, GMP at TriLink, describes the advantages and design considerations of using mRNA in your vaccine program.
In this video James Dahlman, PhD, Assistant Professor, Department of Biomedical Engineering at the Georgia Institute of Technology discusses, RNA therapeutics and the role of in vivo DNA barcoding in nanoparticle selection.
In this Webinar Dr. Tal Zaks, CMO at Moderna, will discuss vaccine and trial efforts against COVID-19
In this webinar, you will hear from Dr. Andy Geall about data innovations from seven years of research at Novartis Vaccines on self-amplifying mRNA technology and how this approach could enable the concept of vaccines on demand as a rapid response to a real threat.
In this Webinar Dr. Gregory A. Poland, Director of Mayo Vaccine Research Group at the Mayo Clinic will discuss, SARS-CoV-2: Going Viral.
In this Webinar Dr. Mark Kehrli, Center Director at the National Animal Disease Center will discuss, Coronaviruses in Livestock: Vaccines and International Transport of Viruses.
In this presentation, Dr. Nicole Gaudelli will discuss how her group has transformed off-the-shelf base editors from a technology developed in academia to a promising therapeutic tool through engineering, screening, and directed evolution.
In this Webinar Dr. Barney S. Graham, Deputy Director, VRC, NIAID NIH will discuss, COVID-19: A prototype pathogen demonstration project for pandemic preparedness.
In this video Dr. Anton McCaffrey, Senior Director of Emerging Science and Innovation, at TriLink BioTechnologies discusses the benefits of using mRNA for manufacturing therapeutics.
In this webinar, T.J. Cradick, PhD, who was until recently head of genome editing at CRISPR Therapeutics, will introduce how genome editing is used to engineer cell therapies.
In this video Dr. Anton McCaffrey, Senior Director of Emerging Science and Innovation, at TriLink BioTechnologies discusses, mRNA applications, including gene engineering, gene replacement and immunobiology.
In this webinar, Dr. Wen Xue, Assistant Professor, RNA Therapeutics Institute at the University of Massachusetts Medical School will present, a modular delivery strategy for homology-directed repair by combining lipid nanoparticle delivery of Cas9 mRNA with adeno-associated viruses (AAV) encoding a sgRNA and a repair template.
In this video Dr. Anton McCaffrey, Senior Director of Emerging Science and Innovation, at TriLink BioTechnologies discusses the biology behind mRNA therapeutics.
This panel focuses on the lessons learned from COVID-19 vaccine human trials to date: our current understanding on the evolving trial data, neutralizing antibodies and safety of these COVID-19 vaccine candidates.
In this video Dr. Anton McCaffrey, Senior Director of Emerging Science and Innovation, at TriLink BioTechnologies discusses planning, manufacturing design considerations and processes involved with research and clinical applications.
In this video Dr. Anton McCaffrey, Senior Director of Emerging Science and Innovation, at TriLink BioTechnologies discusses the cap structures .m6Am, Cap 0, Cap 1, and Cap 2 for optimal mRNA synthesis.
In this video Dr. Anton McCaffrey, Senior Director of Emerging Science and Innovation, at TriLink BioTechnologies discusses the capping characteristics, capping methods and comparison data between legacy capping methods ARCA, and CleanCap®, TriLink’s, novel, new capping technology.
In this video Dr. Anton McCaffrey, Senior Director of Emerging Science and Innovation, at TriLink BioTechnologies discusses chemical modification of mRNA including purification methods and sequence engineering.
In this video Dr. Anton McCaffrey, Senior Director of Emerging Science and Innovation, at TriLink BioTechnologies discusses, the Design & Manufacturing of Chemically Modified mRNA Therapeutics: This complete video highlights mRNA therapeutic manufacturing from research to clinical applications.
In this video Dr. Anton McCaffrey, Senior Director of Emerging Science and Innovation, at TriLink BioTechnologies discusses, the path to GMP production including planning and timelines.