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GMP manufacturing of bioconjugates & ADC

Our state-of-the-art facilities and highly skilled team enable us to deliver a comprehensive range of services specifically tailored to your unique requirements for the manufacturing of antibody-drug conjugates (ADCs) and bioconjugates.

GTP Bioways CDMO - Antibody drug conjugate development

Proficient CDMO from biologics intermediate to bioconjugate drug product

With more than 10 years of experience, our team has acquired a deep expertise in bioconjugation development and manufacturing. Our flexible and customer-centric approach allows us to provide customised solutions that align with your specific goals and timelines.

Our cGMP facilities, located in France, are equipped with cutting-edge technologies, enabling us to provide a full spectrum of services to support your bioconjugate projects from early development to commercialisation. Our comprehensive cGMP manufacturing capabilities encompass the production of biologics intermediates derived from both mammalian and microbial hosts, alongside the manufacturing of bioconjugate drug substance and drug product.

Whether you require process optimisation, scale-up, clinical or commercial manufacturing, we have the capabilities to support your project.

Kg-scale manufacturing

We provide various GMP scales to accommodate flexible batch sizes ranging from a few grams to kilogram-scale batches.

Capability to handle OEB6 substances

We have a dedicated suite for the manufacturing of ADC with cytotoxic payloads. Our isolator technology ensures utmost safety in handling cytotoxic substances (OEB 5/6).

10+ years’ experience

Our team has over a decade of experience developing processes and manufacturing a variety of bioconjugates, including antibody-drug-conjugates.

Dedicated GMP conjugation capabilities for cytotoxic payloads

Our advanced facilities are designed to meet the standards of major regulatory agencies. Our cGMP production suite is adapted for up to hundred-litre scale production of bioconjugates.

Our conjugation DS production suite is equipped with:

      • Our isolator technology which ensures utmost safety in the handling of highly cytotoxic substances (OEB6).
      • A stainless steel bioreactor for conjugation
      • Single-use purification equipment (chromatography and TFF)

Along with well-established controls for handling cytotoxic materials (highly potent APIs & extremely potent APIs), we have implemented a quality system and documentation process in compliance with CFR guidelines.

GTP Bioways CDMO - Bioconjugates Analytical Development

Streamline your ADC production with our comprehensive development & manufacturing services

With our unmatched expertise and capabilities, we seamlessly cover every stage of your antibody drug conjugate project, from antibody intermediate production to bioconjugation and GMP manufacturing of drug substance and drug product.

We believe in the power of collaboration

Our team of experts, supported by our project management team, will work closely with you to understand your project requirements and develop a manufacturing strategy that aligns with your timelines and other project constraints.

We foster open communication and maintain a transparent relationship, keeping you informed and involved throughout the entire process to ensure a successful project delivered on time and on budget.

Comprehensive analytical package for bioconjugates characterisation

With over a decade of expertise, our analytical development team is committed to guiding you through every step of your bioconjugate development. Bioconjugates, such as antibody drug conjugates (ADCs), present unique challenges due to their complex composition.

Our expertise lies in tailoring analytical methods specifically to each moieties within the bioconjugate, ensuring comprehensive characterisation. From protein/mAb intermediates to the final bioconjugates, our comprehensive analytical methods package covers a wide range of techniques to support your development. Specifically tailored for ADCs, our analytical package includes, but is not limited to:

GTP Bioways CDMO - Cell line development for Bioconjugates
  • Drug Antibody Ratio (DAR) and quantification of residual free drug
  • Fragment profile, size exclusion chromatography
  • Micro-Flow Imaging
  • Cytotoxicity
  • Residual solvent, if any solvent is used during the manufacturing process
  • Mass spectrometry, used for characterisation and batch release

Our experienced analytical team has the right expertise to handle method transfer, method development, and validation – ensuring a robust process for the successful cGMP manufacturing of your bioconjugate drug substance and drug product.

Discover more about GTP Bioways services

BIOCONJUGATES

ADC Process Development

BIOCONJUGATES

Aseptic Filling

Bioconjugates

Analytical Services