A Conversation with Exothera

Welcome to the July edition of our CDMO Spotlight Series! In this series, we interview CDMOs with the goal of understanding more about their business and their specific differentiation within their sectors. 

It was a pleasure interviewing Andrew Klauk, Senior Inside Sales at Exothera.  Exothera is a contract research, development, and manufacturing organization (CDMO) dedicated to the production of viral vectors and nucleic acids. As a technology-driven company, Exothera provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the Univercells group. The company delivers accelerated discovery services and process development/optimization to rapidly reach GMP clinical and commercial production of viral vectors and nucleic acids.  Hear from them in their own words what sets them apart in this competitive space. 

1. What are your organization's core capabilities?
   Exothera offers pre-clinical to commercial GMP manufacturing services for RNA and Viral Vectors, including in-process and final release testing as well as F&F. We have industry-leading titers and experience with a variety of vectors, including AAV, AV, VLP, MVA, LVV, baculovirus and more. We can produce everything from small-scale through 2000L (suspension)/600m2 (adherent). 
   
   
2. What sets your organization apart from its competitors?
    
   1. We leverage novel manufacturing technologies invented in-house, such as the scale-X bioreactor and Quantoom RNA production platforms. 
      
      
   2. We have a near 100% customer satisfaction rate over the last four years, which is reflective of our attention to detail and ability to adapt to customer needs. 
      
      
   3. We have a wealth of experience thanks to our 160 colleagues, who have experience from early R&D through large-scale commercial production, allowing us to develop robust processes for our clients. 
      
      
3. What can a potential client expect from the onboarding process? 
   Clients can expect a flexible and bespoke approach to their RNA and Viral Vector needs. Exothera recognizes that each drug product is unique and requires a hand-in-hand collaboration between the two teams. On a practical level, this means: 
   
   
   1. A project team will be assigned to the program, and a project manager and technical leader will act as the primary points of contact for the client. 
      
      
   2. A kickoff will be organized with both teams, and weekly meetings will be held from that point on 
      
      
   3. Quarterly steering committees will be organized to review the project's progress. 
      
      
4. What is your organization's standard communication protocol?
   We are flexible in all aspects of our collaboration including communication. We can communicate with our customers whatever method is preferable. 
   
   
5. How do you handle and address mid-project adjustments? 
   We work with change requests when we identify a need to change anything from the initial contract. In these cases, we thoroughly evaluate the scope of the change and mutually agree on it in a written addendum to the original contract. 

Thanks to Andrew for taking the time to talk with us! We hope this has given you a helpful introduction and insight into Exothera and has enhanced your ability to make informed decisions for you and your business. Be sure to check out Exothera's page and visit their website to learn more.