Reading Scientific Services Ltd. (RSSL)
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Reading, GB
Reading Scientific Services Ltd is a global leader at the forefront of scientific analysis, consultancy, product development and training, serving the pharmaceutical, biopharmaceutical and medical device industries.
Pharmaceutical and Biopharmaceutical Services
• GMP QC Testing
• Raw Material, API and Finished Product Testing
• Biopharma Characterisation and Comparability
• Method Development, Validation or Transfer
• Pharmacopoeial testing (USP, EP JP etc)
• Biosimilar Testing
• Forced Degradation and Stability Testing
• Problem solving and contaminant identification
• Extractables and leachables
• Cleaning validation
• Physical and structural characterization
• Microbiological analysis
• Investigative and trouble shooting analysis
• Research and development (R&D) support
• Global analytical emergency response 24/7
GC capability: Agilent (6890 / 7890) and Perkin Elmer GC systems (Clarus 680), with inlet capabilities including direct injection, headspace (Turbomatrix 110) and cool on column. Detectors: FID, TCD, NCD and ECD.
GC-MS: capabilities for E&L and impurity investigations using the following instrumentation:
Agilent 7890A GC-MS (EI and CI source capability): Agilent GC-MS single quad, with Electron ionisation and Chemical Ionisation source. Autosampler, and headspace analysis (Perkin Elmer headspace trap) compatibility. This instrument is used for E&L studies, investigations and routine GC-MS analysis. Split board, so it can analyse FID and MS at same time if required.
Agilent 7890B GC-MS: Agilent GC-MS single quad, with Electron ionisation. This instrument is used for E&L studies, investigations and routine GC-MS analysis.
The following equipment is used for Extractable&Leachable (E&L) studies, Analysis of Nitrosamines and Impurity Investigation and Elucidations:
- Agilent 6545 Q-ToF: An accurate MS connected to a UPLC. This is a key instrument for Impurity Investigations, where the combination of accuracy of the mass ions, the separation capability of the UPLC (compared to traditional HPLC), and the sensitivity of the instrument (positive and negative) allow us to investigate most pharmaceutical-based species. The fragmentation (MS/MS) is vital for the structural elucidation during the investigation. Additionally, we have both electrospray ionisation (ESI) and atmospheric chemical ionisation (APCI) ion sources, which helps extend the range of chemical species to be analysed.
- Agilent 6495 TQ LC-MS: in conjunction with the APCI meets very low thresholds which is required for nitrosamine analysis. This instrument is designed for Quantitative Analysis (method development and validation) such as nitrosamines.
- Thermo QExactive Orbitrap LC-MS: a highly capable MS with a very high mass accuracy connected to a UHPLC. It has the ability to analyse in both positive and negative polarity together, making it the best instrument for Extractable&Leachable (E&L) studies.
Immunochemical characterisation of proteins using ELISA alone or in combination with Western Blot
Comprehensive range of analysis to ICH Q6B and EMA Guidelines:
Comparability
Method development & validation
Molecular weight or size
Protein or peptide sequencing
Post Translational Modification (PTM)
Disulfide-mapping
Forced degradation studies
Immunochemical properties by ELISA or Western Blot
Glycosylation analysis
Amino acid composition
Aggregation studies
Bioassay for potency
Bioassay for ELISA
Troubleshooting & investigations
Assay development for host cell proteins
New Sterility Service.
Fast 16 day turnaround available and a fantastic first year offer.
Product Validations available now!
We provide a comprehensive pharmaceutical and biopharma DS and DP release testing service to support you in ensuring the identity, purity, stability and quality of your products. Please contact us for details.
The long term stability of drug products (and other healthcare related products) is key to its quality, efficacy, safety and commercialisation. The stability of a product can be assessed in many ways e.g. physical stability (e.g. tablet crumbling, precipitation, viscosity), chemical (e.g. API degradation) or microbiological.
It is therefore vital to carry out stability studies that conform to ICH requirements and that challenge your prototypes and products in a range of environments.
Stability Storage
Our pharmaceutical stability services include a range of monitored temperature, humidity, and light stability storage cabinets which comply with ICH Guidelines, covering requirements for climatic zones I to IV.
Our stability storage conditions:
-80°C and -20°C
5°C
25°C/60%RH
30°C/65%RH
30°C/75%RH and 40°C/75%RH
We can store Schedule I to V controlled drugs and low temperature storage is available. In addition, we are able to set up non-standard temperature/humidity conditions upon request.
Our storage facilities are secure, fully validated and maintained and are 21CFR compliant monitored 24 hours a day, with a dedicated out of hours response team on call in case of emergency.
Whether you require storage only, or in combination with in-house analytical testing, we can tailor our stability service to meet your needs.
Stability Testing
We have a vast range of analytical techniques under the general banners of chemical, microbiological and physical testing that can be used to assess the stability of your product and its packaging in accordance with GMP requirements. We have experience in the development of pharmaceutical stability indicating methods, including photostability and other stress conditions. From protocol preparation to the issue of final reports, we offer comprehensive project management, plus advice and support.
Identification, isolation and purification of process related impurities can be critical to the development and manufacture of pharmaceutical products. Our technical specialist’s expertise in chromatographic and spectroscopic techniques can support with the isolation and identification of impurities from pharmaceutical products or active pharmaceutical ingredients (APIs). Preparative scale isolation is carried out using techniques including preparative liquid chromatography HPLC. Advanced spectroscopic techniques can then be used to identify the impurities of interest, these include nuclear magnetic resonance spectroscopy (NMR; 400Mhz)), mass spectrometry (MS; see LC-MS section for more details) and Fourier transform infra-red spectroscopy (FTIR). Once the impurity has been identified, we can also offer further scale-up for the isolation of larger quantities of impurities for use as reference materials. We are able to scale-up customer specific methods or develop reproducible extraction and purification methods for your products and API’s.
Services include:
o Impurity isolation
o Impurity characterization
o Sample purification
o Method development
Techniques available:
o Preparative High Performance Liquid Chromatography (Water Autopurification LC prep system)
o Chromatography Techniques: Reverse Phase (RP-HPLC), Ion Exchange (IC), Normal Phase (NP-HPLC) and HILIC o Liquid Chromatography Mass Spectrometry (LC-MS; see in the section above for more details)
o Solid Phase Extraction (SPE)
o Fourier Transform Infra-Red Spectroscopy (FTIR)
o Nuclear Magnetic Resonance Spectroscopy (NMR; 400Mhz)
o Ultra-violet/Vis Spectroscopy (UV/Vis)
RSSL offers a rapid services to help you identify unknown proteins in you biopharma products.
We help you ensure the microbiological quality of your pharmaceutical, medical device and healthcare products, demonstrate that you are meeting regulatory requirements and prove that you have good hygienic production procedures.
You can rely on our MHRA-inspected microbiology laboratory to test your product’s microbiological quality and safety and provide method development and validation services. We also partner with you in instances where pharmaceutical microbiology testing, consultancy and troubleshooting are required, for continuous improvement of your processes and procedures or in response to a specific incident.
We perform microbial limits testing for specific pathogens, bacteria, yeast and moulds at all stages of the production cycle, from raw materials, finished products and medical devices.
In addition to this, we also offer preservative efficacy testing, kinetic turbidimetric LAL (Limulus Amebocyte Lysate) endotoxin analysis, analysis of water, challenge testing, and environmental monitoring to fully support in ensuring the microbiological quality and of your products.
Microbiological services include:
Typical product types tested:
Extractable and leachable (E&L) testing and analysis is critical in maintaining the quality of your drug product or combination drug delivery device. As part of the drug development and route to market, it is vital to identify both the substance and source of any leachable as they may significantly alter the identity, strength or quality of the drug, risking patient safety. There are a number of analyses which must be performed in order to comply with regulatory guidelines, and we can assist throughout with extractable and leachable testing:
In the first instance, an extractable profile needs to be determined for all materials which will come into contact with your drug product. Once it has been determined whether any extractables in this profile are present as leachable within the product, you also need support in quantifying amounts and establishing the biological risk based on exposure. Analytical support can be during all stages of this process. E&L testing has been performed on a wide variety of containers, closures and medical combination drug delivery devices using state-of-the-art equipment and expertise.
The following instrumentation is used for the E&L studies:
LC-MS
Thermo QExactive Oribtrap LC-MS: A highly capable mass spectrometer with a very high mass accuracy connected to a UHPLC . It also has the ability to analysis in both positive and negative polarity together, making it the best instrument for Extractables and Leachables Study.
GC-MS
Agilent 7890A and B GC-MS (EI and CI source capability): Agilent GC-MS single quad, with Electron ionisation and Chemical Ionisation source. Autosampler, and headspace analysis (Perkin Elmer headspace trap) compatibility. Split board, so can analyse FID and MS at same time if required.
ICP-MS
Agilent 8800x ICP-QQQ
Choose us as a partner for method development and validation, and you gain access to an experienced, specialist multi-disciplinary team. For both APIs and drug products, we have the capabilities to support you through the entire drug lifecycle.
Our cross-laboratory, multi-disciplinary approach, combined with exemplary customer focus and communication, makes us an ideal partner for method development and validation activities. You can trust us to manage projects effectively and achieve key milestones.
We understand that as companies focus on achieving ever shorter timescales of drug to market, a tailored and pragmatic approach is vital in both Active Pharmaceutical Ingredient (API), Drug Product (DP) and medical device method development and validation activities. Many years of experience working with a diverse client base and multitude of different dosage forms means we can guide and advise you on developing robust, fit-for purpose methods appropriate for the specific phase of the development life-cycle. Our specialists offer a wealth of knowledge and advice on areas ranging from sample preparation and extraction techniques to regulatory aspects.
Following successful method development, we can perform method validation in line with an approved protocol at a level that reflects the ICH requirements for the particular project type and stage of API/DP development.
Techniques available include:
Method parameters include (based on ICH guidelines):
We specialise in resolving chemical contaminant issues for the pharmaceutical industry, using in-house specialist expertise combined with a range of analytical techniques and state-of-the-art GMP-qualified equipment.
Our expertise in contaminant identification is well known, with our team’s expert understanding of the variety of sampling, extraction and analytical methods available enabling us to provide you with the most thorough and effective analysis possible, whatever the analyte. Our multi-disciplinary approach enables us to support you in incidents of accidental or deliberate contamination, counterfeit and adulteration, and manufacturing or processing failures.
We understand the business impact of chemical contamination, and the importance of a rapid response to ensure consumer safety and protect your brand. Work with us for analysis and investigative consultancy and you gain an expert partner in resolving contamination issues. As well as identifying the contaminant, we support you in finding the root cause (whether accidental or malicious), understanding the safety and quality implications of an incident, and taking appropriate corrective action. Our analytical techniques include ICP-MS analysis as well as other spectroscopy methods.
Pharmaceutical contamination is often an emergency situation, where speed in resolution is imperative. You may wish to consider membership of our 24/7 Emergency Response Service (ERS) for guaranteed technical support whenever you need it.
We perform real-time stability and shelf-life testing of ingredients and finished products to support you with food product development, claims substantiation testing and troubleshooting.
Assessing stability over shelf-life is a crucial stage in new food product development and reformulation. You need to ensure that your product maintains its characteristic flavour, texture, structural and chemical features throughout the length of its stated shelf-life.
We provide stability and shelf-life testing for raw ingredients and finished food products under a range of conditions, ensuring that you have full understanding of product changes and behaviour over time. We measure changes over shelf life for components such as sweeteners, preservatives, colours, fats, oils, and vitamins, looking at texture, rheology and more. We can also support you with food analysis and testing (including fats and oils testing) to ensure any claim you make about your product can be substantiated over its entire shelf-life for food product development and reformation.
For fats and oils testing and for finished products containing them, we provide an accelerated oxidative stability testing service using Rancimat and Oxipres equipment. Accelerated testing allows you to narrow down potential formulations to the most promising for real-time testing, and to assess the impact of different processing conditions on stability. Your food product development timescale is therefore shortened with our lipid analysis and lipid testing capability, leaving a quicker route to market. Our NPD consultancy has the knowledge to support you with your new product development process.
Protein Characterization Services
Glycosylation Analysis Services
Spectroscopy Services
Chromatography Services
Purification Services
Protein Services
Biochemistry & Molecular Biology Services
Microscopy Services
Imaging & Spectroscopy Services
Proteomics Services
Business Operations and Logistics Support Services
Drug Development Services
Drug Discovery & Development Services
USP Testing Services
Protein Sequencing Services
As part of impurity elucidation projects, a 400Mhz NMR is currently used. In the near future, a Bruker 600Mhz will be added to the 400Mhz service.
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