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Tepnel Pharma Services Limited is a private limited company registered in the Scotland (registered number SC635641.
History
The business was formed in 1972 as a part of the Royal Pharmaceutical Society of Great Britain with the remit of teaching Pharmacists basic chemistry and microbiological analysis of medicines. During the 1990's the business served as one of the UK's Medicine Control Laboratories working on behalf of the then Medicines Control Agency as a part of the Medicines Testing Scheme whilst providing outsourced quality control testing in the areas of analytical chemistry and pharmaceutical microbiology.
In 2001, the business was acquired by Tepnel Life Sciences PLC and merged with the Scotlabs Bioanalytical business in Glasgow to create Tepnel Scientific Services Ltd. The two discrete business units were relocated to the current location in 2007 and in 2008 the business was further expanded through the acquisition of Wildlife DNA Services Ltd, to add molecular genetic testing services. The business was further acquired by Gen-Probe Incorporated in 2009, as a part of a larger transaction. In 2012, Gen-Probe Incorporated merged with Hologic Incorporated to form the diagnostics division of Hologic Inc., from which the business traded as Tepnel Pharma Services, the contract pharma services brand of Hologic Ltd.
In 2020, a management buy-out was concluded which saw the brand returned to the ownership of the local leadership team with a vision of creating an employee owned company based and owned in Scotland with a focus on value added quality control testing of proprietary medicines that supports drug development and improves patient outcomes.
Services
Tepnel is dedicated to the provision of Pharmaceutical Quality Control Testing in support of Drug Development and Improving Patient Outcomes.
Tepnel Pharma Services is a Scottish based FDA and MHRA inspected contract research laboratory. We support pharmaceutical research and development for both small and large molecules with an emphasis on inhalation, oral dosage, parenteral and peptides/proteins. Providing CMC services from preclinical enabling stability to batch release testing on all formulation types though:
· Over 40 years of experience as a QC Laboratory. Knowledge and experience held by long serving employees giving continuity on independent testing and advice.
· Quality Control -The pharmacopoeia chemistry and microbiology analysis required for APIs, raw materials, excipients and finished products.
· Method Development & Validation to ICH requirements for APIs, Finished Products and Cleaning Validations. Over 1000 methods validated to date.
· Peptide, Antibody & Protein assays (ELISA, SDS Page, Western Blotting, MS etc..)
· Handling capability for up to OEB4 high potency compounds & controlled drugs (Sections 1 - 4 part I & II including Cannabinoids).
· R&D support other than regulatory submission requirements to support the manufacturing process.
· Forced degradation studies - exposure to elevated temperatures, freeze/thawing, mechanical stress, oxidation, light etc..
· Technical Transfer/Method Transfer/Method Verification
· Stability Testing to ICH guidelines across the range of Climatic Zones including ASAPprime (Accelerated Stability Assessment Program for excipient compatibility studies).
· Batch release testing.