Almac Supports Clients in Response to New, Stringent, FDA Heavy Metal Mandates by Investing in ICP-MS Equipment

As the Industry faces the tightest ever new heavy metal mandates from FDA, stipulating the control and documentation, where appropriate, of all elemental impurities in drug products, drug substances and excipients, Almac has invested in state of the art ICP-MS equipment at their European Headquarters, Craigavon, UK to future-proof clients’ drug development programmes to satisfy these requirements and support their clients with these demanding new regulations.

In compliance with USP <232 & 233>, EP (2.4.20), and ICH Q3D, all components, processes, packaging and final product  must be tested for the presence of heavy metals, and inductively coupled plasma mass spectrometry (ICP-MS) is the most suitable technique to meet the requirements of these, and future regulatory requirements.

Therefore, to prepare for current and future implications of these mandates, Almac has built on its mass spectrometry capabilities, investing in the industry leading Agilent 7900 ICP-MS and Mars microwave digestion technology. This ICP-MS instrument offers exceptional matrix tolerance and unmatched interference and false positives removal with a He collision cell. It includes Ultra High Matrix Introduction (UHMI) technology that enables routine measurement of samples containing up to 25% total dissolved solids (TDS), 100 times higher than the traditional matrix limit for ICP-MS. The high organic kit allows the introduction of samples dissolved in pure solvent, samples which previously required microwave digestion.

Linda McCausland, Head of Almac’s Physical Sciences and Spectroscopy stated: “These mandates dictate a significant shift in the attitude of FDA towards heavy metals in all aspects of drug development. Customer focus is our top priority, and the enhanced services offered from this additional investment will provide assurance for our clients whilst complying with the regulatory guidelines.”

The acquisition of this new instrument complements Almac’s current suite of LC-MS and GC-MS technologies, which were part of a recent $2 million investment in Almac’s analytical laboratories.

Stephen Barr, Managing Director of Almac Sciences added: “We are delighted we can support our customers through the challenges of FDA’s stringent new mandates for heavy metal analysis. This investment reinforces our commitment to fully support our clients through every aspect of their drug development programmes.”

Agilent Technologies were chosen as the preferred vendor to supply the mass spectrometers to Almac. Declan Murray, Sales Manager noted: “Agilent Technologies are delighted that Almac has invested in the industry leading Agilent 7900 ICP-MS. Agilent has a long and successful relationship with Almac and we’re looking forward to working with their analytical team to strengthen this relationship even further.”