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Analytics & Formulation for biologics

Thanks to its team with longstanding experience in biotherapeutics development, GTP Bioways provides expert services for the characterisation and formulation of a wide range of biologics.

Commercial manufacturing of small batches for nanodrugs

Expert analytical development for biologics

To provide the highest quality, our manufacturing services are supported by integrated analytical capabilities and expertise.

Our QC team is uniquely proficient at developing analytical methods for the characterisation of a diversity of molecules from conventional monoclonal antibodies to complex proteins – including enzymes, growth factors, immunocytokines, virus-like particles and peptides.

We are very familiar with global cGMP requirements and ICH guidelines and strive to ensure that the data generated through our analytical characterisation and validated release methods conforms to regulatory specifications.

A comprehensive range of analytical services

Our experienced analytical team masters an extensive range of methods to expertly support process development activities and product release.

Our labs are equipped with cutting-edge instruments to ensure we provide advanced characterisation of your product.

The routine activities of our analytical and quality control teams include:

    • Method development and validation
    • Analytical support for USP and DSP
    • DS and DP release for all clinical phases and up to commercialisation
    • Stability studies
    • Raw material testing and environmental monitoring
GTP Biologics
Advanced Biodesign

Expert services compliant with regulatory requirements

We are very familiar with global cGMP requirements and ICH guidelines and will integrate this knowledge into our customised programme to ensure the success of your project.

Advanced Biodesign

Formulation development

Getting formulation right from the start of early development can mitigate risk for your biotherapeutic development and help save valuable time.

Our team, bolstered by the strength of experience over more than 800 different protein projects, is able to offer the most appropriate formulation for your specific protein.

We use Design of Experiment (DoE) principles to optimise the formulation of your molecule whilst mitigating risk.

After identifying which excipients and conditions allow for maximum product stability, we test them in parallel through systematic, real-time accelerated studies.

Discover more about GTP Bioways services

Biologics

Microbial GMP Manufacturing

Biologics

Mammalian GMP Manufacturing

Biologics

Fill & Finish