As a result of COVID-19, immense pressure has been put on the Life Sciences industry to manufacture existing treatments and develop new break-through medicines on accelerated timelines. The demand for existing treatments, such as small-molecule drugs, has increased exponentially and the race to develop new vaccines, medical devices and disinfectants has been widely reported.

The Impact of COVID-19: The Demand for a Flexible Approach & Rapid Response

The impact of COVID-19 has required the industry to be agile and responsive in order to adapt to these demands: timelines have become tighter, research focus has been re-deployed and production of certain medical treatments has increased. Further to this, the outlook is unpredictable and calls for organisations to show flexibility in their approach to adapt to future developments.

Consequently, the collaboration and communication between researchers, manufacturers and CROs is more important than ever to ensure the success of COVID-19 research and development.

RSSL’s Multi-Disciplinary COVID-19 Action Group

In response to COVID-19, RSSL has formed a COVID-19 Action Group – a multi-disciplinary team comprised of RSSL specialists, primed to support with COVID-19 related analysis, including vaccine excipient testing, contaminant identification and cell-based bioassays.

The purpose of the group is to provide comprehensive support with any COVID-19 related enquiries, delivering rapid solutions and technical support throughout your project.

Offering a range of expedited turnaround times to suit your needs, including our 24/7 ERS service, our team are here to provide the analytical support that you require on critical COVID-19 related projects.

Our range of services include:

  • Hand Sanitiser and Disinfectant Testing

Hand sanitiser is a critical aspect in the fight against COVID-19. RSSL are equipped to test both raw materials, to determine purity, and finished hand sanitiser products to determine alcohol content and screen for impurities.
RSSL can also perform disinfectant efficacy testing to BS EN standards (such as BS EN 1276 and BS EN 13727) which provides quantitative data that the finished product is efficacious against a wide panel of micro-organisms.

  • Pharmaceutical Raw Material Testing

RSSL offer MHRA and FDA accredited GMP raw material analysis as per pharmacopoeia monographs (EP, USP, JP, BP, CP) and non-compendial methods. RSSL can assist with method development, verification and validation for your APIs, excipients and drug products.

  • 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.

  • Glass Vial and Container Closure Testing

Assuring container compliance and container/vaccine compatibility by application of a range of chemical and physical stress testing procedures, such as hydrolytic resistance, container closure integrity testing and other compendial or bespoke analysis.

  • Finished Product Release Testing

RSSL provide QC release testing on drug products (including Schedule I-V controlled drugs), working on client projects within all phases of development through to marketed products. Our offering ranges from chemical, physical and microbiological testing, to metals, biopharmaceutical and sub-visible particle analysis.

  • Problem Solving and Contaminant Identification

RSSL’s well-equipped laboratories work to GMP standards and our staff have extensive experience in identifying foreign material in pharmaceutical raw materials, process intermediates and finished product vials and syringes. Our team utilise a range of techniques including SEM imaging, FT-IR and EDXMA.

  • Sterility Testing

Sterility testing is a vital regulatory requirement for manufacturers of 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.

View our recent Sterility Series webinar, "COVID-19 Prevention Measures for those working in GMP & Healthcare Facilities" on demand, click here.

To download the associated Whitepaper "Considerations of COVID-19 Prevention Measures for those working in GMP Pharmaceuticals and Healthcare Facilities" please click here.

  • ICH Stability Studies

The long-term stability of medical products 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 Guidelines, covering requirements for climatic zones I to IV.

  • Extractable and Leachable Studies

RSSL deliver bespoke extractables and leachable studies on a range of container and closure materials from pre-filled syringes, vials, intravenous bags, stoppers, dispensing tubing and many other forms of drug delivery devices, using a range of analytical technologies (LC-MS, GC-MS, ICP-MS).

  • Viral Bioassays and Interferon Bioassays

RSSL can assist with a selection of cell-based bioassays in line with guidelines including ICH Q2 (R1) and ICH Q6B. Our team tailors our analytical services to the needs of our partners to create bespoke services, using methods and techniques such as in-vitro cells, ELISA and real-time PCR. These techniques can be used to study vaccine potency and viral attenuation, for example.

  • Host Cell DNA and Protein Services

RSSL’s expertise can help to ensure that in-process contamination by host cell DNA and host cell proteins has been removed during the production of biopharmaceuticals, including Vero cell lines.

  • Biopharmaceutical Characterisation & Analysis

RSSL can help to develop bespoke methods for RNA characterisation and gene banking, viral vector characterisation and oligonucleotide analysis to meet your requirements.

Find out how RSSL’s partnership with Ethypharm enabled the fast-track release of priority medicine for COVID-19 here.

Download our roadmap for more on our multidisciplinary expertise and extensive portfolio of analytical methods will help you navigate your biopharmaceutical challenges.

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 to discuss your requirements.

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