Globally a wide range of candidate vaccines are under development with the aim of protecting against life-threatening diseases to human and veterinary diseases. RSSL offers a comprehensive suite of vaccine testing methods to GMP, to support throughout the development of vaccines, from batch release of raw materials to a full characterisation package.

Our range of services include:

Bioanalysis

RSSL have capabilities to develop a wide range of bespoke GMP methods including ELISA, CE-SDS, bioassays, SDS-PAGE, Western blots, qPCR, HPLC and LC-MS methods. Depending on your needs some, or all, of these methods can be used to detect vaccine response, characterise vaccine delivery systems, evaluate the protein, glycoprotein, DNA, RNA, carbohydrate, lipopolysaccharide, lipid and lipoprotein components of vaccines.

These methods can also be used to support vaccine studies including the assessment of specific antibody, biomarker and cell-based bioassays in response to vaccine administration. We can support the characterisation of the humoral and cellular immune response to vaccines, assessing functional antibody, cytokines and T cell responses. Patient selection through the evaluation of pre-existing immunity and comparison of the magnitude and duration of the immune response comparing pre-vaccination and post vaccination samples.


Sub-visible Particle Analysis

We can detect and quantify sub-visible particles in a wide range of injectables, parenterals, opthalmics, drug production, storage, delivery components and single use systems. RSSL can perform subvisible particulate testing on vaccines through a light obscuration particle count test and/or a microscopic particle count test. If the volume of sample is low, testing can be carried out following a method based upon USP <787> for therapeutics protein injections.


ICH Stability Studies

The long-term stability of vaccines is key to their quality, efficacy, safety and commercialisation. Our pharmaceutical stability services include a range of monitored temperature, humidity, and light stability storage cabinets which comply with ICH Stability Guidelines, including ultra-low temperature (-80°C), frozen (-20°C) and refrigerated (5°C) conditions.


Vaccine Excipient and Buffer Solution Testing

RSSL are equipped to perform a range of analytical techniques including HPLC, LC-MS, GC-MS, Ion Chromatography and NMR to aid in the identification and quantification of vaccine excipients and buffer components.

For vaccine testing, the finished product analysis should cover:

  • Vaccine activity, so BMA analysis (bio-assays, ELISA, HPLC, etc.)
  • Particulates (visible and sub-visible)
  • Sterility and microbiology testing
  • Chemistry (pH, Osmolarity)

Glass Vial and Container Closure Testing

Assuring container compliance and container/vaccine compatibility by application of a range of chemical and physical stress testing to EP, USP and JP, for example hydrolytic resistance, container closure integrity testing and other compendial or bespoke analysis.


Problem Solving and Contaminant Identification

Our investigative team have extensive experience in solving contamination issues - identifying foreign material in pharmaceutical raw materials, process intermediates, and finished product in vials and syringes, utilising a range of techniques, including SEM imaging, FT-IR, and EDXMA, to ensure we get to the root cause. Our state-of-the-art NMR and range of LC-MS and GC-MS instruments will ensure we can elucidate trace contaminants. RSSL also offers a 24/7 Emergency Response Service.


Vaccine Packaging Safety Assurance

RSSL provides all the required pharmacopoeial analysis around any packaging, pre-filled syringes, vials, intravenous bags, stoppers, dispensing tubing, and many other forms of drug delivery devices.

Additionally, our E&L team can support with bespoke extractables and leachable studies on all packaging, designed to your product needs, using a range of analytical technologies (LC-MS, GC-MS, ICP-MS) to provide the necessary information to demonstrate both the compatibility and safety of the packaging with your product.


Nanoparticle and Physical Characterisation

RSSL can support with nanomaterials and physical characterisation offering a comprehensive analytical package to characterise key vaccine features. This includes evaluation of size, shape, morphology, composition, structure, extent of aggregation, level of crystallinity and stability.

Our capabilities include:

  • Particle sizing using dynamic light scattering
  • Zeta potential by electrophoretic light scattering
  • Morphology analysis of particles using quantitative image analysis
  • Emulsion stability using LUMiSizer technology
  • Specific surface area using gas sorption
  • Single particle ICP-MS
  • X-ray diffraction (XRD) analysis
  • Range of Rheological and thermal techniques
  • Determination of specific surface area (BET)

Sterility Testing

Sterility testing of vaccines is a vital regulatory requirement for manufacturers. This applies to any terminally sterilised or aseptic products and needs to be undertaken when bringing a product to market or assessing the post-launch safety of a drug product or medical device. RSSL offer both Membrane Filtration and Direct Inoculation methods, compliant to Ph. Eur. 2.6.1, JP 4.06 and USP <71>, in our purpose-built cleanroom facility.



For more information, please use our Live Chat feature for an instant response, call our Customer Services team on +44 (0)118 918 4076 or email enquiries@rssl.com to discuss your requirements.


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