Quality Assistance: Utilizing Maurice Platforms to Help Customers Bring New Biotherapeutics to Patients in Need

What is Quality Assistance’s mission and how is its work impacting human health? 

Quality Assistance is a contract research organization based in Belgium. We provide analytical services and all the work we do adheres to GMP or GLP regulations. We work from the end of the preclinical phase through the marketing phase in the CMC field and in bioanalysis. We work on all types of products with a strong focus on innovative products, including biologics, such as monoclonal antibodies, bispecific antibodies, ADCs, cell and gene therapies, and more. Our goal is to support our customers by helping them bring their product to the market for patients in need and to help treat diseases that are not easily treated by the standard of care. The focus of our work is to think of the patient first.

What is your role and your responsibilities at Quality Assistance?

My role in the R&D Innovation Department is to focus on new trends. We interact with academic labs, regulatory bodies, key opinion leaders, and our customers. Our goal is to implement all the analytical tools that our customers need today or may need in the future, depending on new regulations. We have two lab teams, one focused on physicochemical tests and biochemistry, including chromatography, capillary electrophoresis, mass spectrometry (MS), and another team focused on molecular and cellular biology, including immunoassays, western blotting, flow cytometry, PCR, and more.

What drove your decision to bring the Maurice/MauriceFlex systems in-house?

For charge variant analysis, we have largely replaced ion exchange chromatography with the icIEF on the Maurice system. The issue we had for quite some time was the ability to identify the charge variants that we detected using icIEF. Prior to the launch of the MauriceFlex, we had to switch to ion exchange chromatography and collect the fractions or couple it directly with MS. Once we brought it in-house, it was the ideal platform for us - the icIEF fractionation capability enabled us to get further insights into the charge variants. For these charge variant fractions, we mainly use intact mass spectrometry analysis to obtain good identification of the peaks, but if we need further characterization, we do peptide mapping using LC-MS. The latter may require us to collect and pool fractions from multiple runs to obtain the required sensitivity to get more information on the post-translational modification, such as deamidation or oxidation. In addition, we also use the Maurice CE-SDS capabilities for protein size analysis.

What are the main challenges that your clients struggle with?

The main challenge our customers face is the identification of the charge variants. The MauriceFlex system helps to answer that question when further characterization is needed outside routine analysis. Once we have the variant identification, we can be confident in what we observe in the routine work in everyday life in the lab. As soon as we have an icIEF method developed to identify the fractions, we try to implement this method early in the development process. Sometimes we also do stress testing to observe more modifications so that we can identify the different peaks that may appear during stability studies. That way, we have all the information available from the start to help de-risk the development of the product.

What solutions do you offer to your customers to overcome obstacles?

We can provide our customers with all the analytical services that they need or that they may need in the future, depending on the regulatory requests. Because eventually, at the end, you develop a drug, you develop methods, you validate methods. We consider ourselves an extension of the teams of our sponsors, so we really want to collaborate with them, to help them solve their problems. We take care of all the analytical work, development, and the characterization of the biotherapeutics.

What are the new trends/therapeutic modalities which you are most excited about?

We work a lot on Biologics, primarily on monoclonal antibodies (mAbs). However, we are working more and more on antibody drug conjugates (ADCs), which have more challenges in terms of analytical characterization. The icIEF profile of an ADC is even more complex than that of a regular mAb. We also see a lot of bispecific antibodies as well as AAVs. AAVs today are quite tricky because there are a lot of safety issues. Many labs are still developing AAVs for rare diseases, and the characterization of AAVs is very complex and can be done at different levels: at the intact capsid level to quantify the empty/full particles, for example, but also at the VP protein level, to get separation between VP1, VP2, VP3 and their potential impurities. We work a lot on these kinds of modalities as well as mRNA, and lipid nanoparticles. The Maurice and MauriceFlex systems help us in this field.

Tell us about your career path at Quality Assistance (QA) that led to your current role.

I joined QA in 2006 after a postdoc in Proteomics, and I worked on the implementation of mass spectrometry platforms for the characterization of biologics.

Over the years, I have had different roles at QA in team management and lab management before I joined the R&D and Innovation Department in 2014. Since I joined the company, I have had the opportunity to gain experience in new areas, including liquid chromatography and capillary electrophoresis, which I had not done before. Now I also see the biological part - the molecular and cellular biology aspect, which is also very interesting. I also have the opportunity now to collaborate with customers and regulatory bodies on drug development, which has become increasingly complex when we deal with these very complex modalities, especially ADCs, AOCs, AAVs, mRNA, and other newer classes of biotherapeutics.

When I started at QA there were about 80 people in the company - today we have 270 employees. We just constructed a new building and have now grown in footprint from 6,000 to 12,000 square meters. We have doubled our size and our capacity. It is really inspiring to be in this company and to see how it is growing as we anticipate for the future.