LGC accelerates the development of new medicines with extractables and leachables services

As regulatory pressure increases companies are saving time and money with effective extractables and leachables programmes

01st December 2016, Fordham, UK – LGC, the international life sciences and measurement c ompany, is successfully preventing pitfalls which can increase drug products time to market. There is increasing regulatory pressure on pharmaceutical companies to investigate the potential interaction between a dosage form and the primary closure and transfer system employed. A thorough scientifically sound extractables and leachables (E&L) programme is, therefore, an essential regulatory requirement.

Designing and implementing a suitable E&L programme can save significant time and cost in development and ultimately help to ensure product safety of drug packaging and delivery systems. LGC, which showcased its E&L services at CPhI 2016 in Barcelona, is helping customers to identify and quantify the compounds present in those components in direct contact with a drug product or patient and the likelihood of clinical exposure to these.

Mike Ludlow, Technical Study Manager, CMC Analytical Services at LGC, explains “LGC works with customers to provide extractables assessment and leachables analysis for a variety of drug formulations and delivery systems, including inhalers, injectables, ophthalmics, intra-venous products and blister packs. LGC has pre-developed survey methodology for the assessment of volatiles, semi-volatiles, non-volatiles and inorganic extractables. LGC discussed its expertise in this area at CPhI, including extraction, deformulation and characterisation of polymeric container devices and drug delivery systems.”

He added, “CPhI was such a worthwhile experience as we managed to meet with many new people and discussed the wide range of challenges involved in providing high quality E&L support for pharmaceutical product development. It was great to engage with industry peers and have constructive discussion, LGC is proud to work with clients and colleagues such as these. Together we are able to support our vision of science for a safer world.”

For more information about LGC’s Extractables and Leachables services, please visit http://www.lgcgroup.com/services/drug-development-services/cmc-services-materials-science-and-pharma-analysis/extractables-and-leachables/#.WCya9jh0x94. To learn more about LGC visit www.lgcgroup.com, or call us at +44(0)1638 720 500

About LGC

LGC is an international life sciences measurement and testing company with leading positions in growing markets. LGC provides a range of measurement products and services which underpin the safety, health and security of the public, including reference materials and proficiency testing, genomics reagents and instrumentation, and expert sample analysis and interpretation. LGC serves customers across a number of end markets including Pharmaceuticals, Agricultural Biotechnology, Diagnostics, Food, Environment, Government and Academia.

LGC’s headquarters are in London and the company employs over 2,500 people, operating out of 22 countries worldwide. Its operations are extensively accredited to international quality standards such as ISO/IEC 17025, ISO 13485, ISO 9001, GMP, GLP and ISO Guide 34.

With a history dating back to 1842, LGC has been home to the UK Government Chemist for more than 100 years and is the designated UK National Measurement Institute for chemical and bio measurement. LGC was privatised in 1996, and is now owned by funds affiliated with KKR.

For more information, please visit www.lgcgroup.com

LGC, Queens Road, Teddington, Middlesex, TW11 0LY, UK

This release was published on openPR.