Accelerating commercialization with custom OEM solutions and GMP
Advances in molecular and immunodiagnostics are enabling a personalized, high-precision approach to health in many clinical areas.
Customized contract manufacturing and original equipment manufacturer (OEM) solutions help accelerate product development from early-stage concepts and prototypes to manufacturing and commercialization. Having access to the right laboratory infrastructure, technical expertise, and consultation services can help you develop your product more effectively, and working with suppliers who follow good manufacturing practices can help you commercialize faster.
In this webinar, we focus on the benefits introduced by lyophilization technology to maximize product or sample stability and shelf life, custom conjugation services to optimize the applications using magnetic bead separation, and good manufacturing practices (GMP) to ensure controlled processes are in place to meet quality standards.
Learning objectives:
• Discuss the cost, workflow, and environmental benefits of lyophilization
• Review the opportunities available through magnetic bead conjugation and re-formulation
• Discuss the importance of GMP to meet quality standards for product commercialization
Webinar speakers:
Amy Webster, Custom Projects Leader, Cytiva
Amy Webster is Custom Projects Leader at Cytiva, managing custom Lyo-Stable formulations and custom plates projects. Since graduating from the University of Bath with a first class honours MChem in Chemistry with Drug discovery in 2011, Amy has gained experience with Binx Healthcare (formerly Atlas Genetics), developing and stabilizing reagent formulations and integrating point of care assays onto automated custom devices. She has also worked for Enigma Diagnostics on the transfer of diagnostic tests and machine builds from R&D to operations as well as validating manufacturing methods and QC tests.
Matthew Davies, Custom Service Leader, Cytiva
Matthew leads the Customised Solutions Team for the Genomics and Diagnostics Solutions business at Cytiva. His team of scientists and engineers are dedicated to helping diagnostic customers launch and manufacture products using Cytiva’s stabilization and conjugation technologies, expertise and global supply chain infrastructure. Matthew has 20 years' experience working across the pharmaceutical, academic and life science industries.
Mitch Gore, Commercial and Technical Manager for the B2B, qPCR, and Custom Oligo product lines at Integrated DNA Technologies
Dr. Gore earned his PhD from Auburn University. He held postdoctoral positions at the University of Alabama College of Medicine in Cardiology and at the University of Wisconsin in Kinesiology, with research interests focusing on the transcriptional regulation of genes involved in cardiac and skeletal muscle growth and adaptation. He was previously the Director of Molecular Biology at Cruachem, Inc. and then Director of Life Science Technologies and New Business Development at Polysciences, Inc. In both of these positions he concentrated on the development and commercialization of new tools for cellular and molecular biology research. He is currently the Commercial and Technical Manager for the B2B, qPCR, and Custom Oligo product lines at Integrated DNA Technologies, where he leads a global team that addresses commercial and technical needs of commercial and academic users of IDT’s products and services.
Renee Rathjen, GMP Product Manager at Integrated DNA Technologies
Renee Rathjen joined IDT as a production scientist over 20 years ago after receiving her Bachelor of Science in Chemistry from the University of Northern Iowa. Renee has 20 years of operational management experience in various IDT manufacturing groups, including Specialty Synthesis, and most recently GMP Manufacturing, which includes synthesis, HPLC purification, and final formulation. Renee recently transitioned into the GMP Product Manager role. In her tenure, Renee has helped define the GMP oligo services and manufacturing practices that IDT offers today, and continues to work closely with customers to ensure that each project’s requirements are met with the highest quality oligos.