Effortless buffer preparation thanks to TOC Analysis on Highly Purified Water
Ablynx, Sanofi - World-class in Ghent
In the middle of the Technology Park in Ghent, Ablynx is researching how to efficiently make new drugs. They use the so-called Nanobodies and Nanobody® technology. These are antibodies from llamas and other camelids.
Ablynx has already developed several treatments based on this technology. After their recent acquisition by the French pharmaceutical giant Sanofi, the focus clearly remains on research & development. The permanent search for new innovations continues in Ghent.
The company has 450 employees who together form a true "Centre of Excellence".
What is it all about?
For Phase 1 studies, the active ingredients have to be cultured in large quantities. For this there is a complete chain of production steps, upstream and downstream processing. The buffers used in this process have to meet the highest quality requirements. The purity of the Highly Purified Water (HPW) that forms the basis for the creation of the buffers is therefore extremely critical. Therefore, during the recent renewals at Ablynx, a dedicated HPW skid has been created. This unit produces HPW for the various departments.
Due to the fact that water quality is so important when creating buffers, online monitoring of the TOC (Total Organic Carbon) is necessary. At Elscolab they found a practical solution: the 450TOC from Mettler Toledo Thornton. This portable online TOC analyser monitors water. This allows Ablynx to guarantee water quality at all times. Buffers that would have been made up of water with too high TOC values cannot be used.
The 450TOC is used to check the various Points-of-Use (8) where and when required. This way, the water quality is ensured and the buffer formation runs smoothly.
We appreciated the openness at Elscolab. Never did we get the feeling that we were asking a simple question, which we were apprehensive of. Every contact was always made in a relaxed atmosphere.
Sindi De Vrieze
Senior Scientist SANOFI
Until recently, the water plant was shared with other research bodies in the same building. Due to the expansion at Ablynx, the water supply was no longer sufficient. Hence the new HPW skid. In the old system, no TOC analysis was carried out. For the new skid, however, this was necessary and the search was on. One option was to have the water quality analysed by an external lab, but that was quickly abandoned. With the portable 450TOC, Ablynx now has its own analysis and is independent of third parties. In this way, work can be done better, more flexibly and in particular, faster.
Why work with Elscolab?
Some of the management at Ablynx participated in an Elscolab seminar. The subject was the measurement of the conductivity of water. During this seminar, the theoretical background and especially the guidelines for pharmaceutical water were highlighted. This was Ablynx's first contact with Elscolab. They immediately felt that Elscolab imparted knowledge and insight to them, which immediately inspired confidence. That’s how the ball got rolling. That bond of trust has only grown through subsequent discussions.
Even though you knew that this was a relatively small project, you did pay due attention to our problems. Elscolab immediately provided us with the necessary knowledge and worked well with us. Your advisory approach is extremely strong and offers great added value.
Sindi De Vrieze
Senior Scientist SANOFI
By using the 450TOC, Ablynx has accrued more knowledge about the critical parameters of HPW. The TOC analyser ensured confidence in the new water skid, guided them through the entire start-up process and ensured water of the right quality at all times.
Everything works fine now and no difficulties are expected in the future. In the unlikely event that contamination does occur somewhere in the entire water system, the cause can be found quickly and easily using the portable analyser.
In any event, Ablynx will certainly be contacting Elscolab for their next 'Pure Water Analytics' challenge.