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Technological Additions Highlight Ballina Upgrades

DNA double helix

With innovative equipment and expanded lab capabilities, we are helping our customers expedite new drugs and therapies to market.

Since its establishment in 2018, our analytical laboratory in Ballina, Ireland has doubled its laboratory footprint. The addition of new laboratory space has enabled us to bring in specialized and advanced equipment, such as the Maurice system from Protein Simple, PDA, CAD, and ELS detectors, and Droplet Digital PCR (ddPCR) methodology.

Our enhanced lab capabilities support release testing and early-stage testing to promote purification efficiency, formulation development, and the quantification of stabilizers for drug development.

The Maurice system is a proven innovation in capillary electrophoresis (CE) technology. It allows for the automated protein profiling of products either by size (CE-SDS) or by charge (cIEF). The cIEF and CE-SDS analyses can be used for a wide variety of products such as mAbs, ADCs, vaccines, or virus-like particles.

Maurice employs ready-to-use cartridges and analyses samples either directly from vials or from a 96-well plate. It produces pI and charge heterogeneity data in less than 10 minutes and size-based CE-SDS data in 35 minutes, reducing testing time significantly.

We strive to anticipate the needs of our clients, and have invested in a number of new detectors which supplement and add to the applications of our HPLC instruments (e.g., PDA, ELS, and CAD). These detectors facilitate the quantification of stabilizers, such as EDTA or polysorbate 80, which may be added to drug products.

Establishing new and pioneering technologies is one of the primary goals in our quest to help our clients bring new drugs and therapies to the market.

We have recently added ddPCR applications to our service portfolio, which can detect and precisely quantify various types of DNA and RNA alterations using either a very small or large sample. It is a useful application for products relating to gene therapy, which is rapidly gaining ground. The field saw a 32% increase in venture funding in 2019.

In addition, we have recently introduced water testing capabilities to our analytical laboratory which complements our well-established and highly experienced microbiological testing function. We can test WIFI, purified water, and sterilized water to USP, EP, and JP.

Some of the tests we can perform include TOC, pH, appearance, conductivity, and nitrates. Our current methods include:

Purpose Methods
Physicochemical Characterization and Identity Confirmation/Comparability
HPLC/UPLC
SDS-PAGE
CE-SDS
Western Blot
Purity/Impurity/Residual Testing
HPLC
ELISA
Western Blot
SDS-PAGE
CE-SDS
cIEF
HPLC
Concentration/Strength/Recovery/Solubility
Total protein assays (UV, colorimetric)
HPLC
Potency/Relative Binding/Activity
ELISA
Ion Chromatography
Drug Product Properties (Liquid and Lyophilized forms)
Appearance
pH
Particulates
Moisture content
Osmolality
Conductivity
Safety
Endotoxin content
Water Testing
WIFI
Sterilized and Purified water to EP, USP and JP

If you'd like to ask our experts about these assays and what they can do for your program, or if you'd like to know more about the capabilities of Ballina, Ireland facility, contact us at [email protected].