In my previous post regarding the differences between capacity and capability, I discussed the point that reasonably successful CDMOs have the capacity to manufacture biomolecules in a reproduceable manner and deliver according to a timeline. However, sometimes clients tend to focus on a near-term timeline when evaluating potential CDMO partners, relegating matters that dictate long-term clinical success to future consideration.
Capacity: The total amount that can be contained or produced
Capability: The ability to do something
*As defined by the Cambridge Dictionary
One of the issues I’ve heard raised in our industry is about how we define capacity and capability. As you can see from the definitions above, these are two very different items. But what do these two terms mean with respect to the manufacture of mRNA drug substance and/or drug product?
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.
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.
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.
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.
These are unprecedented times with challenges we have never seen before. Maintaining a continuous supply of raw materials has become increasingly difficult since the start of the pandemic and with the on-going geopolitical uncertainty. The recent rise in oil prices is also increasing stress on everyone’s supply chains.
One of the many ways we can help you streamline your project is by offering free cloning backbones that have been tested in our production systems. We have recently expanded our portfolio to meet the increasing demands for backbones specifically for RNA production.
