Significant progress in the field of Advanced Therapy Medicinal Products (ATMPs) has resulted in more effective treatment for diseases such as cancer and genetic disorders. The complexity involved in the development process of treatments such as cell and gene therapy products and their increased usage has led to a wide variety of unique therapeutic approaches.

The lack of a single all-purpose solution for the analytical testing of biologics means that to be effective services must be tailored to the client’s specific requirements.

Utilising our 30 years of pharmaceutical experience and strict GMP quality systems we can provide monographed and non-monographed analytical testing, for a wide range of materials used in clinical and commercial cell and gene therapy products.

Collaborative Working

Our comprehensive biopharmaceutical capabilities mean we can offer integrated services across every stage of your therapy development process. From early stage to IND applications, commercial manufacturing, and product release, RSSL has the expertise to meet and exceed your requirements.

Our expert scientists will work with you to determine the most appropriate approach, considering factors such as regulatory compliance and cost effectiveness, to ensure the safety and quality of the final product

Fast & Agile

Your time is precious and Chemistry, Manufacturing and Controls (CMC) testing can often be subject to tight time frames adding another layer of complexity to an already complicated process. We use our knowledge and experience to provide quick turnaround release testing, enabling you to get your therapies to patients as fast as possible. We also offer project management as part of our service, leaving you to make the key decisions whilst we handle the rest.

RSSL provides cell and gene therapy testing services as part of a complete package of required biopharmaceutical tests, enabling partners to rely on a single trusted vendor for all analytical requirements. For further information or to discuss your needs please contact us.

Our Services

  • Complex material, culture media & excipient testing

    • Biological materials characterisation on a product by product basis-Identity, potency, impurities
    • Microbiology (Sterility Testing, Endotoxins, Mycoplasma, Bioburden)
    • Purity (Process Related Impurities)
    • Pharmacopeia- (EP JP USP and other)
    • Elemental Impurities (ICH Q3D)

  • Pathway and Contact Materials

    • Sterility Testing, Endotoxins, Mycoplasma, Bioburden Extractables & Leachables
    • Container Closure Integrity
    • Particulate Matter
    • Foreign particle identification

  • Gene Therapy Product Analysis

    • General Pharmacopeia- Appearance , pH, Osmolality, volume, dose etc.
    • Capsid Analysis – Full & Empty, Zeta potential, Protein Identity & ratio
    • Aggregation , Process and product related impurities - HCP & HC DNA, Residuals

  • Cell & Gene Therapy Release Testing

    • Product Release Testing – on a product by product basis
      • Potency
      • Impurity, Identify, Safety, Stability, Sterility
      • Physical, Chemical, Cellular & Functional QC Testing
      • Absence of Contamination QC
      • Sterility Testing, Endotoxins, Mycoplasma, Bioburden
      • Particulate Matter
      • Foreign particle identification

Protein Biologics Testing

  • Pharmacopeia

    • Appearance , pH, Osmolality, volume, dose uniformity etc

  • Identity, Purity & Integrity

    • Mass Spec (ESI-MS) - Intact Mass, Protein Variants, Post Translational Modification, Peptide Map
    • Charged Variants - IEX, cIEF, IEF
    • Fragments & Aggregates - SEC, DLS, SDS PAGE, cSDS, SEM, RP-HPLC
    • Chromatographic Profiles - HPLC and UPLC - o RP, HILIC, IEX, SEC
    • Glycosylation - Site, structure

  • Potency

    • ELISA
    • Cell Based BioAssay

  • Safety

    • Microbiology & Sterility
    • Process & Product Related Impurities
    • Host Cell Protein and DNA – both kit based and custom assays
    • Particulate matter

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