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Tepnel Pharma Services Limited
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Tepnel Pharma Services Limited?
Overview
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.
Standards & Methodologies
Supporting drug development, improving patient outcomes
Tepnel Pharma Services specialises in the provision of pharmaceutical testing in support of drug development. Our cGMP pharmaceutical testing facilities are located in Livingston, Scotland where we are committed to providing laboratories with the most innovative and effective technologies from sample receipt through to report delivery. improvement and development of our processes to create value propositions on behalf of our clients.
Overview of Services
Lot and Batch Release Testing
Regulatory compliant batch release testing & QC testing of pharmaceuticals and biopharmaceuticals for release in the European and Global Markets. Our rapid and flexible service ensures a quick turnaround that shortens the period from product manufacture to availability to the patient.
Pharmacopoeia and Raw Materials
Testing Tepnel offers a comprehensive raw material testing, pharmacopoeial testing and microbiology testing of pharmaceutical excipients and ingredients service to meet a wide range of different purposes.
ICH Stability Testing and Storage
Our on-site analytical chemistry and microbiological support together with a range of validated cabinets and chambers ensure that your ICH stability testing projects are carried out efficiently and in compliance with ICH Q1 guidelines.
ICH Method Development & Validation
Services include analytical method development & validation in accordance with the ICH Q2 (R1) guidance and cGMP for both small and large molecules
Please find links below to Tepnels Pharma Services Limited capability and service offering:
https://12h8e71zr50fl8dba334rmw1-wpengine.netdna-ssl.com/wp-content/uploads/2020/03/Tepnel-GMP-Servi...
Qualifications, Certifications, Accreditations & Licenses
Lab Gallery
Industries Served
- Aerosols
- Biopharmaceuticals
- Biotechnology
- Clinical Research
- Clinical Trials
- Controlled Substances
- Drug Delivery Systems
- Gene Therapy
- Healthcare and Medical
- Laboratories or Research Facilities
- Laboratories or Research Facilities
- Life Sciences
- Microbes and Microorganisms
- Pharmaceutical
- Pharmaceutical - Pediatric
- Pharmaceutical - Active Pharmaceutical Ingredients (API)
- Pharmaceutical - Compounding
- Pharmaceutical - Over the Counter (OTC)
- Pharmaceutical - Small Molecules
- Pharmaceutical - Sterile
- Pharmaceutical Excipients
- Pharmaceuticals - Large Molecules
- Proteins and Peptides
- Vaccines
- Veterinary Medicine
Testing Types
- Absorbance
- Acid-Base Properties
- Active Ingredient
- Active Pharmaceutical Ingredient API
- Aerobic Plate Count
- Agar Diffusion
- Alkalinity
- Amino Acid Analysis
- Amino-acid Composition
- Amino-acid Sequence
- Anaerobic Plate Count
- Analytes
- Analytical
- Analytical Chemistry
- Anti-Bacterial
- anti-bacterial efficacy
- anti-microbial
- Anti-microbial Efficacy
- antimicrobial
- Antimicrobial Activity
- Antimicrobial Effectiveness
- Antimicrobial Effectiveness Test (AET)
- Antimicrobial Efficiacy
- Appearance
- Arsenic
- Assay Determination
- Assay Development
- Assay Development
- Assay Specificity
- Bacterial Endotoxin (LAL) - Gel Clot
- Bacterial viability
- Bio Burden
- Bioburden
- Cannabidiols CBD
- Cannabinoid or cannabis testing
- Cannabinoids Profiling
- Capillary Melting Point
- Chemistry
- chemistry analysis
- Chlorides
- Chromatography
- Chromatography Purity
- Citric Acid
- comparison studies
- Conductivity
- Container and Closure
- Container Closure Integrity Testing (CCIT)
- Container Integrity
- Degradation Products
- Degradation Products - Quantification
- Density
- Direct Inoculation Sterility
- Direct Transfer Sterility
- Disintegration
- Disk-Diffusion Method
- Dissolution
- DNA Extractions
- Drug Release/Dissolution
- Drug Substtance Characterization
- ELISA
- Endotoxin
- Endotoxins
- Environmental Monitoring
- Excipients
- Extractables / Leachables
- Flourescence
- Gas Chromatography
- Gas Chromatography/Flame Ionization Detection (GC/FID)
- Gel Clot
- Gel Permeation Chromatography
- Gram Staining
- Hardness
- High performance liquid chromatography (HPLC)
- High performance liquid chromatography/mass spectrometry (LC/MS)
- ICH
- Impurities
- Inhalation
- JP
- Karl Fischer
- LC/MS
- Lot Release
- Materials Characterization
- Melting Point
- Microbial
- Microbial Contamination
- Microbial Counts
- Microbial Enumeration Test (MET)
- Microbial ID
- Microbial Identification
- Microbial Limit Testing (MLT)
- Microbial Total Viable Count
- Microbiological Contaminants
- Microbiology Culture
- Microorganism Identification
- Microorganisms
- Microscopic Analysis
- Microscopic Particles
- Monograph Verification
- Nucleic Acid Isolation
- Osmolality
- Particulate Analysis
- Particulate Contamination
- pH
- Photostability
- Physical Chemistry
- Physicochemical Properties
- Potency
- Potency Verification
- Preservative Efficacy
- Protein and Peptide Analysis
- Quality Control
- Raw Material
- real time stability studies
- Real-Time Stability
- Real-Time Stability Studies
- Refrative Index
- Specific Rotation
- Spectroscopy (UV/VIS
- Stability
- Sterility
- Thickness
- Total Aerobic Microbial Count (TAMC)
- UV/Vis
- Viscosity
- Visual Inspection
- Water Content
Publications
Tepnel Pharma Services Limited has not posted any publications.
DISCLAIMER: This Laboratory Profile was provided by the company above.