New format for PharmaFluidics’ µPAC™ columns to meet surging customer demand

We talk with the team at PharmaFluidics about how their recent changes in sourcing and production allows them to face demand from a growing community of users

6 Jan 2020

Charlie Carter

Life Sciences Editor

Over the recent months, PharmaFluidics has focused on scaling up production of its µPAC™ nano-LC columns in response to a surge in customer demand and popularity. We spoke with Ania Saeys, PharmaFluidics’ Supply Chain and Production Manager, about the impacts of this change. “It was clear that we had to scale up our in-house assembly and coating line, as well as foundry supplies of the backbone silicon wafers, to keep up with this demand. Upscaling to a process validated, industrial foundry for backbone silicon wafers supplies was also an excellent occasion to update the column format” Saeys explains.

PharmaFluidics µPAC format changes — PharmaFluidics µPAC™ 200cm nano-LC columns ©PharmaFluidics

Good market acceptance

Following the introduction and commercial launch of its flagship product, the PharmaFluidics µPAC™ 200cm nano-LC column immediately attracted a lot of interest for its exceptional resolution, sensitivity, robustness, reproducibility, and retention time stability. Proteomics researchers have been keen early adopters of this µPAC™ technology. A special highlight of 2019 has been receiving the European Proteomics Association (EUPA) award: “We are very grateful to EUPA and the Proteomics community for recognizing the µPAC™ contribution to improving and standardizing nano-LC/MS proteomics workflows, and setting new standards, breaking records and advancing the field of proteomics.”

Scaling up

In face of popular demand and a growing community of users, PharmaFluidics decided the time was right to scale up its in-house assembly and coating operation and start sourcing the backbone silicon wafers from a large-scale, process-validated, industrial foundry. This transition provided an excellent occasion to update the column format, which resulted in a new – longer and thinner – µPAC™ chip and casing format. Irrespective of the change in format update, the columns maintain the same internal physical characteristics and chromatographic performance as the nano-LC µPAC™ 200cm columns of previous format. Additionally, the new casing format has a width of only 20mm, allowing the columns to fit in a larger range of commercially available column ovens.

How µPAC™ column production is changing

1. Concluding a period of comprehensive process transfer, PharmaFluidics will start sourcing backbone silicon wafers with its proprietary µPAC™ column designs from a large scale 6” industrial foundry, according to a validated and quality assured production process.

2. PharmaFluidics will produce from its extended in-house column coating installation, which is adapted to produce new format, current, and future nano-LC and Cap-LC products in a flexible yet consistent way.

3. There is no change in specifications or performance for users; the new format allows the µPAC™ columns to fit in a larger range of commercially available column ovens.

Saeys confirms that: “PharmaFluidics’ new format µPAC™ nano-LC columns retain the same internal physical characteristics as the µPAC™ nano-LC columns of previous design; the only change is the slimmer format. So, customers can seamlessly incorporate these into their existing applications and experience the exact same performance as before.”

Column validation and quality control

The most important consideration in meeting customer needs and ensuring the performance of the new format µPAC™ nano-LC columns is, as expected, the need to safeguard the quality of the final product as well as the quality of the in-house coating process. Every µPAC™ column leaving PharmaFluidics’ facilities is tested at every stage of the manufacturing process, including thorough quality control on each individually-quoted column.

Saeys explains: “Every µPAC™ column is released based on its own extensive quality control report and we are proud to deliver this for each analytical column shipped. I think it's not only the technology but also the production and the quality assurance that is very important for our customers.”

Timeline for changeover:

The new, slimmer 200cm columns will be rolled out globally in January 2020.

Changing from the current to the slimmer µPAC™ format promises seamless incorporation of the new columns into your application projects, with no effect on the performance of your chromatography.

Now that the new 200cm-column format has been validated, the 50cm column will also get this slimmer format in early 2020.

The unique separation power of µPAC™

PharmaFluidics’ micro Pillar Array Columns (µPAC™) are manufactured using lithographic micromachining techniques. The separation bed of these microchip-based chromatography columns consists of an array of highly ordered free-standing pillars. The µPAC™ columns demonstrate low “on-column” dispersion obtained by the “perfect order” of the separation bed. This makes µPAC-based chromatography unique and offers several advantages compared to conventional column technologies like a high-resolution power, unrivaled longevity, and unique reproducibility.

Ania Saeys PharmaFluidics Production & Supply Chain Manager

About Ania Saeys:

University degree in mechanical engineering (KULeuven)

Started her career as an equipment engineer and after 5 years switched to a supplier quality job in an automotive OEM supplying company (ISO/TS 16949 certified)