In Purification, One Size Does NOT Fit All
Downstream challenges in mRNA production
In my previous post, I brought up important questions that should be asked when beginning to design a scalable manufacturing process to meet specific use requirements. In this post, some of the difficulties encountered in process development are reviewed.
Combining Resources to Streamline and Standardize Therapies
Academics and manufacturing making processes better
Witnessing firsthand the growth of cell and gene therapy to progress more programs to the bedside is an exciting time in the biotechnology industry, particularly with new partnership approaches being developed. I was able to get an overview of one particular partnership during a podcast featuring Tom Foti, VP of Protein Business unit at Aldevron, and Kris Saha, Ph.D., Associate Professor of Biomedical Engineering, Medical History and Bioethics at the University of Wisconsin.
Four Major Steps Involved in mRNA Manufacturing
From potential to solution
For more than two decades, in vitro transcribed (IVT) messenger RNA (mRNA) has been considered for its potential to address unmet medical needs and to transform the development and manufacture of medicines. This potential was suddenly realized by the unprecedented response to Covid 19, ushering in a new era in the application of mRNA technologies to solve challenging health problems.
Unspoken Themes
Big topics not always on conference agendas
For events such as Biotech Week Boston, industry leaders, suppliers, regulatory agencies and academia come together to collaborate, present and partner on topics related to biotechnology, specifically therapeutics. And every year there is an unspoken theme you don’t see on the agenda, where speakers, attendees and sponsors discuss shared pain points, challenges and what the future could hold.
How Did My Project Get So Expensive?
The Hidden Costs of Multiple Tech Transfers
Move fast. Limited funds. Novel ideas. These are consistent themes I’ve noticed in conversations with hundreds of biotechs over the last 20 years, and rightly so. However, these elements sometimes overshadow the need to evaluate the complexities and costs associated with GMP manufacturing in support of a clinical trial, along with what’s needed for manufacturing at phase III and beyond.
The Benefits of Streamlining and Standardizing Plasmid DNA for Cell and Gene Therapies
Manufacturing standardization for cell and gene therapies (C>) has received increased focus in the last several years, spurred by the rapid exponential growth witnessed in this field. The resulting need for improved access to high-quality raw materials, including plasmid DNA, has made standardization integral to streamlining the development process for this biologic product category.
Applying Experience - Partnering with Pioneers to Deliver Plasmid for Discovery Through Commercial Application: On Demand Video
Aldevron recently hosted a webinar through FIERCE Biotech titled: Applying Experience - Partnering with Pioneers to Deliver Plasmid for Discovery Through Commercial Application.
Listen below to hear featured presentations from Cindy Biffert, VP of GMP Nucleic Acids Business Unit at Aldevron, Barry Byrne, M.D, P.h.D, Associate Chair of Pediatrics and Professor at UFL, Director of Powell Gene Therapy Center, and Earl and Christy Powell University Chair in Genetics, and Christine Sheaffer, Manufacturing Operations Lead at Spark Therapeutics.
TIDES TV: Tackling mRNA Manufacturing Challenges
Nate Spangler, Ph.D., Director of Innovation & Strategy at Aldevron discusses the challenges of manufacturing mRNA under the increased demand and helpful strategies to solve them.
Nate was interviewed by Michael Dunnet for TIDES TV.
TIDES TV: Achieving GMP Quality in Protein Manufacturing
Justin Byers, Client Relations Senior Manager, GMP Custom Protein Services at Aldevron discusses important considerations for achieving GMP quality protein manufacturing for advanced therapeutics and vaccines.
He was interviewed by Michael Dunnet for TIDES TV.