The last few years have seen significant developments in the field of Advanced Therapy Medicinal Products (ATMPs), leading to the innovation of next-generation therapeutics for previously untreatable and often life-limiting illnesses, ranging from genetic disorders to cancer.

However, the lack of single, all-purpose analytical solutions, combined with the rapidly evolving regulatory environment, can make the development and manufacture of these novel therapies challenging.

To support the delivery of innovative cell and gene therapies, we offer integrated analytical services that can support early-stage development through to IND applications, commercial manufacturing and product release.

Knowledgeable and experienced

By combining our 30 years of pharmaceutical experience with our state-of-the-art facilities, we can provide tailored analytical solutions to meet your individual product requirements.

As our team’s knowledge and expertise spans both chemistry and biochemistry, we can create cost-effective and regulatory-compliant approaches for ensuring the safety and quality of ATMPs at all stages, from raw materials qualification through to finished product analysis.

We are also committed to sharing our knowledge and playing a key role in the development and upskilling of companies within the cell and gene therapy sector. Through our training and consultancy services, we provide the expertise required to help bring cell and gene therapies to market.

Reliable and dedicated

We understand that gene therapy development and manufacturing timelines can be tight, and Chemistry, Manufacturing and Controls (CMC) testing can add additional complexity.

To help you meet your deadlines and accelerate the delivery of life-changing treatments to patients, we strive to provide quick turnaround release testing. We also provide comprehensive project management as a part of our service, enabling you to make the key decisions while we handle the rest.

Our cell and gene therapy testing services are provided as part of a complete package of biopharmaceutical tests, enabling you to rely on us as a single trusted vendor that can meet all of your analytical requirements. For further information or to discuss your needs please contact us.

Our services

  • Raw materials testing

    Using GMP quality systems, we can provide regulatory-compliant characterisation of raw materials used in clinical and commercial manufacture of cell and gene therapy products. This includes:

    • Serum
    • Serum-free cell culture media
    • Defined protein components
    • Buffers

    In addition to applying existing pharmacopeial monographs, our extensive capabilities in both chemistry and biochemistry enable us to develop bespoke, cost-effective methodologies that can meet your individual project requirements.

  • Biosafety testing

    We offer comprehensive sterility testing to help you ensure the safety and quality of your ATMP and maximize your confidence in the sterility of your terminally sterilised or aseptic products. We also offer a range of services to identify both product- and process-related impurities including:

    • Biological impurities
    • Biosafety testing
    • Environmental monitoring
    • Packaging and pathway analysis
    • Sub-visible particle identification
  • Product-specific characterisation

    Through combining traditional biopharmaceutical testing methods with innovative cell and gene therapy-specific analyses, we provide a diverse range of services for assessing ATMP identity, potency and purity. These services include:

    • Full/empty capsid ratio analysis
    • Capsid protein characterisation
    • Tissue-tropism testing (in-vitro)
    • Viral genome analysis and many more

    As a part of these services, we can design bespoke combinations of tests that are specifically tailored to your project’s unique needs.

  • Stability testing & storage

    Offering secure, fully validated, 21CFR-compliant sub-zero storage facilities, we can help you to ensure the quality, efficacy and safety of your finished ATMP will be unaffected by cold chain transport.

    Through this service, we can conduct a full complement of tests, including cell-based assays and sterility tests, to enable you to achieve ICH-compliance and reassure you that your novel therapy can be successfully delivered to patients.

  • Regulatory & training support

    We offer over 50 training courses aimed at the cell and gene therapy sector at various levels, which can be delivered either in-person or online through an e-learning platform. View our interactive training course calendar here.

    In addition to our training services, we also have a team of expert consultants with in-depth knowledge of the cell and gene therapy regulatory landscape. From support with regulatory document preparation to clinical trial submissions, our experts can help you to navigate the evolving requirements of this industry.

Interested in this service?

CGT case study

Check out our latest case study assisting a clients therapy to progress to clinical study

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