Reading Scientific Services Ltd. (RSSL)

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.

RSSL’s Quality Control testing expertise, supporting the pharmaceutical and healthcare industries, provides a portfolio of chemical, physical and microbiological services.

RSSL can perform QC testing on raw materials, drug substances and drug products (including Schedule I-V controlled drugs) and can work with client projects within all phases of development through to marketed products.

We also work with clients to verify or transfer methods into our laboratories, ensuring a quick and easy route to QC release testing.

We run an efficient and effective GMP laboratory providing high quality results delivered to our client’s desired timelines. View our broad range of techniques below for both small molecule and biological applications.

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 but not limited to preparative liquid chromatography (HPLC and ÄKTA), freeze drying and solid phase extraction. Advanced spectroscopic techniques can then be used to identify the impurities of interest, these include nuclear magnetic resonance spectroscopy (NMR), mass spectrometry (MS) 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:

• Impurity isolation
• Impurity characterisation
• Sample purification
• Method development
• Method validation

Techniques available:

• Low Pressure Liquid Chromatography with ÄKTApurifier
• Preparative High Performance Liquid Chromatography (HPLC)
• Chromatography Matrices - Reverse Phase, Ion Exchange and Normal Phase
• Liquid Chromatography Mass Spectrometry (LC-MS)
• Solid Phase Extraction (SPE)
• Freeze Drying
• Fourier Transform Infra-Red Spectroscopy (FTIR)
• Nuclear Magnetic Resonance Spectroscopy (NMR)
• Ultra-violet/Vis Spectroscopy (UV/Vis)

RSSL offers a rapid services to help you identify unknown proteins in you biopharma products.

RSSL offers a comprehensive consultancy service. This includes support for cleaning validation, and environmental monitoring. We offer training on how to perform swabbing and where and how to perform environmental monitoring. This is supported by complete pharmaceutical microbiology laboratory services.

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:

• Microbial limits to EP, USP and JP
• Quantitative endotoxin analysis
• Preservative efficacy testing
• Environmental monitoring
• The European Suspension Test (eg EN1276, EN13697)
• Water testing
• Method development and validation

Typical product types tested:

• Oral
• Topical
• Parenteral
• Ophthalmic
• Medical devices
• Raw materials

Extractable and leachable testing and analysis is critical in maintaining the quality of your drug product or combination drug delivery device. Let our expert analysis help you maximise the chance of a positive drug registration.

As part of your drug’s development and route to market, it is vital to identify both the substance and source of any leachables 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. First, you need an extractables profile to be determined for all materials that will come into contact with your drug product. Once it has been determined whether any extractables in this profile are present as leachables within the product, you also need support in quantifying amounts and establishing the biological risk based on exposure.

We can provide analytical support during all stages of this process. We have performed controlled extractable and leachable testing and studies on a wide variety of containers, closures and medical combination drug delivery devices using state-of-the-art equipment, and our specialists’ expertise and experience means you can rely on us to successfully set up and manage your project.

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:

• UltraViolet-Visible (UV/VIS)
• High-Performance Liquid Chromatography (HPLC) with UV. Diode Array (DAD), or Fluorescence Detection (FLD)
• Gas Chromatography with Flame Ionisation Detection (GC-FID)
• Gas Chromatography-Mass Spectrometry (GC-MS)
• Ion Chromatography with Conductivity Detection (IC-CD)
• High-Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD)
• Liquid Chromatography-Mass Spectrometry (LC-MS)
• Atomic Absorption Spectroscopy (AAS)
• Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
• Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES)
• Laser Diffraction (Mastersizer 2000 and 3000)

Method parameters include (based on ICH guidelines):

• Specificity
• Limits of detection and quantification
• Linearity
• Accuracy
• Precision
• Solution stability

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

Training and Teaching 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

Regulatory Affairs Services

Drug Development Services

Drug Discovery & Development Services

USP Testing Services

Protein Sequencing Services