TriLink

There is a robust and promising therapeutic pipeline of mRNA-based medicines. In this webcast, participants will learn how to implement discovery best practices to optimize the path to streamlined mRNA manufacturing. The discussion will include essential steps in establishing a robust process design, crucial for maintaining consistency and quality in mRNA manufacturing.

https://www.pharmtech.com/pt/discovery-strategy-framework

Implementing discovery best practices to set you up for streamlined manufacturing.

Transferring your manufacturing strategy to clinical programs.

 mRNA drug developers and professionals from biotechnology, emerging biopharma, and small to mid-sized pharma


 mRNA professionals from higher education or academia


: R&D, Process Development Scientists, Clinical Research and Supply, Clinical Operations, Quality Assurance, Procurement and Supply Chain


Director of GMP Operations & Process Transfer
TriLink BioTechnologies


 is a director of GMP Operations and Process Transfer with TriLink Biotechnologies (part of Maravai). She joined the company in April of 2020 to build out the process development to GMP manufacturing customer pipeline. She currently leads GMP operations for the Nucleic Acid Services business unit at TriLink Biotechnologies.

Dr Villa has over 10 years of operations leadership experience, most recently leading operation teams such as Proteins, Fermentation, Quality Control and Vectors at Thermo Fisher Scientific. In addition to her operations experience, Dr Villa is a licensed Radiation Safety Officer. She helped build and manage the site’s radiation program alongside her EH&S colleagues. Dr Villa holds a BS in Molecular Cell and Biotechnology. She received her PhD from Virginia Tech in the field of molecular cell and protein biochemistry focused on breast cancer research. With a strong background in molecular biology and biochemistry, Dr Villa has a deep understanding of the complex processes involved in mRNA manufacturing. Throughout her career, Dr Villa has demonstrated exceptional leadership skills, successfully managing large teams of scientists to deliver high quality products. She has a proven track record of driving process improvements and optimizing manufacturing workflows to increase efficiency and reduce costs while promoting a safety driven culture.

Webcasts

Webinar Date/Time: Thu, Oct 26, 2023 11:00 AM EDT

mRNA Discovery Strategy Framework to Set You Up for Manufacturing Success

In this roundtable discussion, panelists will share insights and lessons learned on how to overcome key barriers in the development and manufacture of mRNA-based cell therapies.

https://www.pharmtech.com/pt_w/critical-barriers

There is a robust and promising therapeutic pipeline of mRNA-based cell therapies. This roundtable panel will discuss critical barriers in the drug substance development process for mRNA-based cell therapies. The discussion will include process development lessons learned, insights from analytical development programs, and how manufacturing innovations can help you navigate and overcome these key barriers.


Join this roundtable panel to learn how to overcome critical barriers when developing mRNA-based cell therapies. Specific topics include:

Common challenges or barriers in the manufacture of mRNA for cell therapies

Process development and manufacturing lessons learned and insights

Critical steps in analytical development and characterization

Key considerations and questions to ask when evaluating a potential manufacturing partner for mRNA-based cell therapies

: R&D, Process Development Scientists, Clinical Research and Supply, Clinical Operations, Quality Assurance, Procurement and Supply Chain




Associate Director of Process Development
TriLink BioTechnologies

is the Associate Director of Process Development at TriLink BioTechnologies, where he oversees the development of mRNA and pDNA. Evan has extensive experience in this area, having held various positions in mRNA and oligonucleotide manufacturing, GMP, and process development, where he supported several drug substances. His expertise spans biologics through synthesis, chromatography, scale-up, and process optimization covering development, manufacturing, and analytical testing.



Senior Director of Analytical Services and Quality Control
TriLink Biotechnologies

 is the Senior Director of Analytical Services and Quality Control at TriLink Biotechnologies where he oversees all analytical aspects of method development and validation to product release and stability to support regulatory filings for both small and large molecules. Prior to TriLink, Khaled held various positions in Quality Control, Research and Development, and Manufacturing where he supported a number of Drug substances and Drug products (both small molecules and biologics) from clinical phase to commercial. These include diverse experience and expertise ranging from discovery to manufacturing with Fortune 500 firms, as well as small entrepreneurial businesses in the areas of synthetic, analytical, colloidal, surface modification, protein, and antibody modification and purification covering both manufacturing and analytical testing and characterization.




Associate Director of mRNA Research & Development
TriLink Biotechnologies

 is the Associate Director of mRNA Research & Development at TriLink Biotechnologies where she oversees the development of optimized transcription reactions using novel modified cap analogs, evaluation of mutant or alternative RNA polymerases for reduced dsRNA formation, and upcoming innovative design technologies for mRNA platforms. She and her team also investigate ways to increase protein expression in various model systems. Jordana’s background is in molecular biology and she has contributed to TriLink’s mRNA services for 9 years.

Webinar Date/Time: Tue, May 23, 2023 11:00 AM EDT

Overcoming critical barriers when developing mRNA-based cell therapies

Developing an analytical framework for success using a chemically modified mRNA can be compared with those for traditional biologics. Though much of the regulatory filing requirements can be compared with those for traditional biologics, others are not yet well defined. As such, it’s especially important that control on quality and consistency is maintained to ensure efficacy, purity, and safety.
Like traditional biologic products and processes, mRNA-based products require controls on:


Quality of the starting material (including cell banking)

Identification of critical process parameters

Establishment of environmental controls to meet safety requirements

Thorough characterization of structure, purity, and efficacy

We will discuss some of these challenges and solutions to support the requirements for characterization of structure, purity, and, efficacy of a well characterized mRNA drug substance



Critical raw materials to support the synthesis of mRNA for therapeutic development

Drawing quality parallels between biological molecules and mRNA

Characterization of structure, purity, and efficacy of an mRNA drug substance

Process development scientists in pharmaceutical companies

Program department heads and pharmaceutical executives


Senior Director, Manufacturing and Quality Control
TriLink BioTechnologies

 is the Senior Director of Manufacturing and Quality Control at TriLink Biotechnologies where he oversees all analytical aspects of method development and validation to product release and stability to support regulatory filings for both small and large molecules. Prior to TriLink, Khaled held various positions in Quality Control, Research and Development, and Manufacturing where he supported a number of Drug substances and Drug products (both small molecules and biologics) from clinical phase to commercial. These include diverse experience and expertise ranging from discovery to manufacturing with Fortune 500 firms, as well as small entrepreneurial businesses in the areas of synthetic, analytical, colloidal, surface modification, protein, and antibody modification and purification covering both manufacturing and analytical testing and characterization

Wednesday, October 5, 2022 at 11:30am ET | 10:30am CT | 9:30am PT

Developing an Analytical Framework for Success using a chemically modified mRNA can be compared with those for traditional biologics,. As such, it’s especially important that control on quality and consistency is maintained to ensure well characterized drug substance.

TriLink

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