SK pharmteco announces new standalone Analytical Services from its SK biotek Ireland Swords Campus

SK pharmteco announces new standalone Analytical Services from its

SK biotek Ireland Swords Campus

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.’

ABOUT SK PHARMTECO & SK BIOTEK IRELAND

SK pharmteco is the single customer-facing team comprised of SK biotek Ireland, AMPAC Fine Chemicals, SK biotek Korea, Yposkesi and most recently CBM - The Center for Breakthrough Medicines.  Creating substantial market synergies in the API and Cell and Gene Therapy (CGT) CDMO space by combining highly complementary assets and expertise, this union enables us to provide the highest-quality services to our customers.

We offer state-of-the-art facilities and technology: energetic chemistry, continuous flow processes, controlled substances, particle engineering, high potency – with world-class potent handling capability (down to low nanogram per cubic meter levels).  We have multiple cGMP manufacturing and development sites, with >1000 m³ of small molecule capacity across 6 sites plus 750,000 sq. ft. of CGT capacity plus dedicated analytical services facilities across USA, Korea, France, and Ireland.

SK pharmteco is a portfolio company of SK Inc. (South Korea) and serves as a strategic part of SK’s growing pharmaceutical sector.    

SK biotek Ireland has been manufacturing API and Intermediates for almost 60 years at our facility in Dublin, also known as Swords Campus.  For the last 35+ years, Swords Campus has maintained its leadership in the development, scale-up and commercial manufacture of highly potent chemical intermediates and API.  SK biotek Ireland offers multi-scale plants (from grams to 100s of kg) capable of handling material with Occupational Exposure Limit (OEL) ≤ 10 ng/m³.  SK biotek Ireland Analytical Services currently offers method development and validation, a variety of testing services as well as physical characterization independent from any manufacturing contract.

This integrated facility combines manufacturing plants, R&D and QC laboratories within the same building.  Through the implementation of a strong safety compliance policy and adherence to high-quality and safety standards, Swords Campus has a proven track record as a reliable supplier of HPAPIs to multiple customers.

Additional information about SK biotek Ireland can be obtained by visiting our website at https://www.skbiotekirelandanalytical.com/