6


Table 2. Intermediate precision of relative peak area (%) measured with different CA brands. For each CA brand sets of 6 runs were done on 3 different days and with 3 capillary batches (n=18). For the assignment of isoform peaks refer to Figure 2.


Isoform Pharmalyte


1 2 3 4 5 6 7 8 9


Average RSD% 10.3 20.7 25.0 23.0 12.4 5.8 2.8 na na


1.2 0.6 0.8 0.7 0.7 0.9 2.9 na na


HR AESlyte


Average RSD% 9.1


20.8 26.1 22.4 12.7 5.9 2.9 na na


0.9 0.5 1.9 2.9 1.3 1.0 2.6 na na


SH AESlyte


Average RSD% 10.6 21.5 11.5 14.3 22.7 16.0 3.5 na na


3.5 3.0 6.7 3.0 3.2 3.5 7.2 na na


Servalyt


Average RSD% 10.6 14.4 6.1


12.9 24.4 14.0 3.9


11.3 2.4


0.8 1.4 2.4 3.9 5.0 8.7


14.3 2.7 1.2


Conclusion


This study shows that mAb charge heterogeneity analysis by high resolution cIEF on fluorocarbon-coated capillaries works well with different commercially available CA brands. All tested CA brands enabled the measurement of mAb charge isoform pI and relative peak area with high precision.


Performance differences between CA brands were observed in terms of resolution and CA-specific background. A similar performance was observed for Pharmalyte and HR AESlyte. In comparison to these CA brands, a slightly increased resolution and background was observed for SH AESlyte. The best resolution was observed for Servalyt.


However, this CA brand also showed the highest CA-specific background. Given the good performance with different CA brands combined with the high stability and ease-of-use of fluorocarbon-coated capillaries, the deployed high-resolution cIEF method presents an attractive choice for the characterisation of proteins in the biopharmaceutical industry.


References


1.Kristle, T., Stutz, H., Wenz, C. & Rozing, G. Principles and applications of capillary isoelectric focusing. Agilent publication number 5991-16660EN (2014).


2.Righetti, P. G., Simó, C., Sebastiano, R. & Citterio, A. Carrier ampholytes for IEF, on their fortieth anniversary (1967-2007), brought to trial in court: The verdict. Electrophoresis 28, 3799–3810 (2007).


3.Mack, S., Cruzado-Park, I., Chapman, J., Ratnayake, C. & Vigh, G. A systematic study in CIEF: Defining and optimizing experimental parameters critical to method reproducibility and robustness. Electrophoresis 30, 4049–4058 (2009).


4.Salas-Solano, O. et al. Intercompany Study to Evaluate the Robustness of Capillary Isoelectric Focusing Technology for the Analysis of Monoclonal Antibodies. Chromatographia 73, 1137–1144 (2011).


Figure 3. Overlay of 6 CIEF consecutive runs obtained with HR AESlyte on a single day with the same capillary. Shown is the range between pl marker 7.0 and 5.5 (A) and a zoom in on mAb isoforms 1-3 (B). For better comparability, the time axis of the electropherograms were aligned with both pI markers as reference points (indicated by the red vertical lines).


5.Wenz, C. Monoclonal Antibody Charge Heterogeneity Analysis by Capillary Isoelectric Focusing on the Agilent 7100 Capillary Electrophoresis System. Agilent Technologies Publication Number 5991-1142EN (2012).


6.Wenz, C. Monoclonal Antibody Charge Heterogeneity Analysis by Capillary Isoelectric Focusing on Fluorocarbon Coated Capillaries. Agilent Technologies Publication Number 5991-2885EN (2013).


Read, Share and Comment on this Article, visit: www.labmate-online.com/articles Antec Scientific is the New Trade Name of Antec Leyden BV and Antec (USA) LLC


Antec headquartered in Zoeterwoude, The Netherlands with sales offices in Boston, MA, USA, provider of electrochemical detectors for use in (U)HPLC and electrochemical reactors for use in Mass Spectrometry, announced today the corporate name change to Antec Scientific, effective immediately. The name change comes along with a new corporate Identity and the launch of an updated website later this month.


CEO and President Jean-Pierre Chervet said: “Over the last few years, Antec has become more and more scientifically engaged with national and international collaborations from academia and industry. Internships of young scientists such as masters, PhD fellows, post-docs but also trainings of research fellows from industry in electrochemistry have become common practice at Antec. Furthermore, we have increased our focus on product innovation and new applications reflected in recent patent applications and granted patents.”


“We are very excited about the introduction of our new company name. We believe the name Antec Scientific allows us to better represent our business and reflects much better what we are doing, i.e, not only manufacturing and selling scientific instruments but also the knowledge and expertise to become successful in the use of electrochemistry,” added Martin Eysberg, the company’s Sales and Marketing Director.


“Changing our name to Antec Scientific formalises a shift in corporate strategy that has been underway for several years and we will pursue this strategy to provide our customers with state-of-the-art electrochemical instruments as well as with the knowledge to become successful in the field,” said Dr Nico Reinhoud, Antec’s Managing Director.


For more information about the name change or to learn more about Antec Scientific, please visit AntecScientific.com. 41954pr@reply-direct.com


New Hassle-Free Gas Generator Maintenance Plan Introduced


Peak Scientific has introduced a unique and cost-effective maintenance plan for their gas generators which allows customers to fix maintenance costs for a set number of years. The Fixed Price Preventative Maintenance plan (FPPM) was developed to remove the worry of rising annual servicing costs. This cost-effective solution negates the need for lab managers to factor the variable costs of annual maintenance into increasingly pressurised budgets, by introducing a measure of stability and predictability at an affordable fixed cost.


In order for gas generators to continue performing at operating specification, periodic maintenance is required. FPPM allows those covered to pre-schedule necessary maintenance around their workload, with all servicing carried out by certified Peak service engineers. This allows users to rest assured in the knowledge that their generator will be thoroughly serviced by a qualified professional at a time that will not impact their workflow.


Peak understands that ‘time is money’, particularly in the commercial laboratory sector, which is why the company has taken steps to ensure that customers lose as little time as possible. In the rare event that unplanned generator maintenance is required, the FPPM plan provides guaranteed around the clock priority access to Peak Scientific’s global technical support team.


As its name suggests, Fixed Priced Preventative Maintenance is a fixed price regardless of a generator’s specific maintenance requirements at each scheduled interval.


Marina Campbell, Global Service Sales Manager, commented: “We have developed the Fixed Price Preventative Maintenance plan in response to the needs of our customers. Listening to many of our customers, it was clear there was an appetite for a plan which allows users to manage and predict their scheduled maintenance costs by locking them in for a set period. The FPPM plan gives our customers a more cost-effective way to manage their generator servicing.’”


Those covered by the plan also receive a 20% discount on any additional services or replacement parts they may require from Peak Scientific. To find out more about this hassle-free maintenance plan visit http://www.peakscientific.com/protected/fixed-price-preventative-maintenance/


41630pr@reply-direct.com


INTERNATIONAL LABMATE - APRIL 2017


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