SK pharmteco (SKPT) a global CDMO, part of SK Inc., is pleased to announce that it has launched SK biotek Ireland Analytical Services offering full cGMP testing services including testing of Highly Potent Active Pharmaceutical Ingredients (i.e. material with Occupational Exposure Levels (OEL) < 0.1 µg/m³) from SK biotek Ireland’s Dublin-based pharmaceutical manufacturing plant.
The Swords site, SK pharmteco’s Global Center of Excellence for material science including particle engineering is now adding SK biotek Ireland Analytical Services. These services, already available to SKPT’s API manufacturing customers, are now offered independently of any manufacturing activities. Services range from Method Development and Validation, to Mutagenic Compounds determination, as well as Reference Standard Characterisation and Physical Property Characterization of Active Pharmaceutical Ingredients (API).
A range of Testing Services are also available including Stability and Release Testing, with a full offering of Compendial Testing Methods.
SK biotek Ireland Analytical Services’ highly-trained and experienced analysts use state-of-the-art instrumentation and techniques including: Spectroscopy (IR, Raman, NMR), Mass Spectrometry, Microscopy, X-Ray Crystallography, Chromatography (HPLC, GC), Particle Size Analysis, Powder Characterisation (Rheometry, Surface Area, Vapour Sorption), Thermal Analyses (Gravimetry, Calorimetry) and offer analytical support throughout the method lifecycle using Quality by Design concepts.
By launching SK biotek Ireland Analytical Services, SK pharmteco is replicating in Europe what is already in place at AMPAC Analytical in California and Virginia, with a broad range of services supporting both method development and product release.
SK pharmteco’s incoming CEO, Joerg Ahlgrimm said, ‘Although we feel our customers are best served by combining their analytical needs with our ability to develop and manufacture their products, we understand that this may not always be the preferred option. Our model is flexible to allow customers access to our leading analytical capabilities alongside our manufacturing capabilities. Having this European base in Analytical Services complements our US footprint and gives our customers a global solution.’
President of SK biotek Ireland, Joyce Fitzharris, said, ‘SK is investing heavily in Swords, $75m to be exact, $10m of which is purely on technology, the remainder on expanding the capacity within the current Swords footprint. Analytical Services is just one of the many parts of the business benefiting. Swords are also leveraging their existing capability to handle highly potent molecules by manufacturing Antibody Drug Conjugate (ADC) payloads and working with SK biotek Korea, in supplying commercial quantities of the key linker units. Further investment is planned for Dublin to allow broad scale assembly of ADC backbones.’
Associate Director of Analytical R&D, Dr Matthew Webberley, said, ‘With the exceptional technical capabilities available within Analytical Services at this integrated facility, combining manufacturing, R&D and QC labs side by side, it makes perfect sense to expand the offering, opening our labs up to non-contract manufacturing customers.’