shutterstock_195352859It was 22nd February 2016 at 8 am. The sun was shining and the sprinklers were quenching the thirst of the surrounding vegetation as we pulled into the parking lot. We had arrived at Ajinomoto Althea, Inc. in San Diego. It wasn’t until we entered the building and started talking to the scientists there that I realised just how extraordinary this contract manufacturing organization (CMO) was. I had come to speak with Kevin McCowen, a Supervisor of Analytical Development who had recently taken installation of a Thermo Scientific™ Vanquish™ Horizon UHPLC System, to find out how they were getting on.

 

At HPLC 2016 I met up with Kevin again, and I grasped the opportunity to dig deeper into the ethos of Althea, and what it is that really sets them apart…

Name: Kevin McCowen

Job Title: Supervisor, Analytical Development

Hobbies: Beer, triathlon, protein analytics, painting

Q: How does Althea stand out from the crowd?

A: At the turn of the century, Althea was established as a CMO that primarily focused on large molecule biologics.  The company has invested significant resources to build manufacturing and testing platforms and think there is an advantage in having designed our facility and processes specifically to work with these therapeutics.

While we are a fully owned subsidiary of a large company (Ajinomoto), we still have a small company culture that partners with clients, affords flexibility and nimbleness, and functions as an extension of our client’s development team, not just as an extra pair of hands in the lab.


…we still have a small company culture that partners with clients, affords flexibility and nimbleness, and functions as an extension of our client’s development team…


Q: How important is partnering with sponsors, for both parties?

A: I look at science as a creative endeavour.  A pharmaceutical company is working to create novel ways to treat or cure disease.  When the contract lab that you choose is just a pair of hands then you get a result. When you work with a development partner like Althea you get an experienced partner that contributes significant know-how to develop a solution. We want to be involved in that creative process so that we don’t stop thinking once the instruments provide the data and are shut down; we use those results to work with our partners to generate further solutions.

This benefits the pharmaceutical company because we’re invested in their success; we’ve become an integral part of the development process. It benefits Althea because we’re striving to be ahead of the cutting edge and be a part of the creative process of other pharma companies. This gives us the opportunity to do what we love doing, creating new ways of doing and thinking about science.

Creation of novel ways of seeing things has been part of the driving force for new capabilities such as the Crystalomics formulation group and building, from the ground up, a state-of-the-art facility for bioconjugation and fill/finish manufacturing and testing of antibody drug conjugates.

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Q: What does collaborating with a company such as Thermo Fisher Scientific bring to you?  

A: Being able to collaborate with an innovative company like Thermo Fisher Scientific has a huge benefit, not only to Althea, but also to the companies with which we partner. It gives us close access to scientists and engineers that created the instruments we work with day in and day out. We’ve also had the opportunity to work on some early stage products being developed at Thermo Fisher and have helped develop analytical solutions specifically for the biopharmaceutical analytical laboratory.

It also provides different insights into problems, much like academic/industry collaborations, industry labs and instrumentation/analytical solutions vendors like Thermo Fisher approach problems differently. It’s these different points of view that open up how we see and approach different problems.

Q: What are the analytical challenges that you and your team face?

A: The need for speed and efficiency while not sacrificing quality. Manufacturing processes often run late into the night and intermediate samples need to be tested to continue the purification the next morning. Sometimes this requires that we analyze a limited number of samples to get a representative set of data that the manufacturing group can use to make decisions for the next steps in the process.

With some of the work we’re doing on the Vanquish Horizon UHPLC System, we’re pushing run times down and enabling the collection of more types of data in a single analysis, so we’re able to analyze the complete set of in-process manufacturing samples prior to continuation of the process. Also, we’re able to provide more complete answers about different properties, such as protein folding, that can help in producing consistent and predictable batches of product, time after time.


…we’re able to provide more complete answers about different properties, such as protein folding, that can help in producing consistent and predictable batches of product, time after time.


Q: What made you choose the Vanquish Horizon UHPLC System?

A: Well, I’ve said it jokingly before that it was our sales rep that made the instrument a front runner for us. It’s worth pointing out that she is extremely knowledgeable and a great resource for us to work with. That being said, we weren’t in the market to purchase an instrument that only incrementally improves upon what we already have in the lab, regardless of anything having to do with great people or sales.

The Vanquish Horizon made sense to us because we were in the market to purchase a true biocompatible instrument and we wanted something that was going to push the limits. Looking to the future of HPLC and UHPLC, I think column technologies are going to drive a lot of the innovation; instruments will need to be able to handle higher pressures. The Vanquish Horizon has one of the highest pressure limits of any of the commercially available UHPLC systems and this positions it well to handle the future development of columns. Looking at the instrument from a lab users perspective, there were a lot of benefits as well. It really was made to meet the needs of the user with simple tool-free fittings and no need to de-stack instruments when changes are to be made. We also saw the higher column compartment temperatures and multiple heating modes had potential to help with separation of larger proteins, particularly antibodies.

Q: How has installation and transition to the new system been?

A: The installation went very smoothly. The Unity Lab Services engineer did the installation and it was done in about a day. We’re all familiar with the Thermo Scientific Dionex Chromeleon Chromatography Data System software, which eased our transition. The software is very intuitive, even for those coming from different platforms. The use of Chromeleon makes the transition to Thermo Fisher instrumentation easy.

Q: Which 3 features of the Vanquish UHPLC System have really made a difference for Althea?

A: We purchased a Diode Array Detector which we’ve been using to look at ways to characterize protein conformations. The detector has surprisingly low noise and low noise fluctuation. This gives us confidence in the data we generate to positively identify small changes in protein conformation. Also the sample pre-compression function leads to great retention time precision making it much easier to work with the data. With a hundred injections we see retention time RSDs on average of 0.02% or less. Finally, speed is important for a lab that is routinely pushed to produce more data in a shorter amount of time. Being able to push the pressure and flow rates up is giving us the ability to produce more data faster.


This gives us confidence in the data we generate to positively identify small changes in protein conformation.


Q: I really enjoyed your presentation at HPLC 2016, the data was fantastic; what challenges do you have planned next for the Vanquish UHPLC System?

A: Thanks, it was really exciting to have the opportunity, and the chance to present it was aided by the collaboration we have with your team at altheaThermo Fisher. The slides will be available at altheacmo.com/resources. Following up on this work we need to look at more proteins to see how sensitive the method is to detecting small changes in different structures. Austin Jackson, who has done a lot of the work for the project, has had some interesting ideas in this regard. We’re also going to start doing some work with antibodies and glycoprofiling using the fluorescence detector.

Q: Finally…what makes you get out of bed every day and go to work?

A: Ha, my four year old daughter! Seriously though, I’ve been lucky to have found a career that I not only enjoy, but one which provides me with continuous growth. Two things at work get me really excited and drive me. First, there is the drive that was always there-the possibility that exists in science. When I think about it, we’re kind of like space explorers. Our work isn’t just about providing answers to problems; it’s also about discovering problems that we don’t know exist yet. It’s fun to work in an environment where we know that at any moment we can recognize something that no one has noticed before. I think it’s hard to truly understand that this is the essence of what we do, without having that “aha!” experience. I was lucky to have stumbled on that early in my career and that is the second part of what drives me; helping other people in the lab see the potential in what we do and that the aha! moment is there, waiting to be discovered. I enjoy this part of the job… what I consider “selling possibility”. It’s a subject I’ve reviewed elsewhere but I think it’s really critical in a knowledge industry like science.


When I think about it, we’re kind of like space explorers. Our work isn’t just about providing answers to problems; it’s also about discovering problems that we don’t know exist yet.