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Aseptic fill & finish

GTP Bioways provides fill and finish services for a wide range of active pharmaceutical ingredients including biologics, cytotoxic molecules and small molecules, in a GMP-compliant environment.

GTP Bioways CDMO - CMC Development

Flexible drug product manufacturing service

GTP Bioways is one of the few CDMOs offering a comprehensive range of services across all stages of the biopharmaceutical value chain, from R&D to cGMP aseptic filling.

With manufacturing capacities of up to 10 000 units per batch, GTP Bioways is ideally sized to deliver your drug product for clinical studies and commercial supply of small batches.

We manufacture liquid injectables in vials or pre-filled syringes and we even have the expertise and the adequate equipment to work with highly viscous gels.

 

At GTP Bioways, we are proud to offer our customers a best-in-class system for aseptic filling for a wide range of API including cytotoxics.

Cell line Development process

Efficient fill & finish service for nanodrugs, biologics and bioconjugates

Our team has a long-standing experience of providing fill & finish services for a wide range of active pharmaceutical ingredients including small molecules, recombinant proteins, monoclonal antibodies and a wide range of other biologics.

Our flexible services and infrastructure will adapt to your unique needs, whether you’re transferring your material to us for fill & finish or we have handled your entire development project.

Customer stories: What they were looking for in a CDMO

Cell line Development process

“We are happy to work with GTP Bioways for our very first clinical trial. This collaboration is a key point in the preparation of our clinical product before its administration to patients. With their brand-new facilities in Toulouse and their aseptic fill and finish operations, GTP Bioways shows all the guarantees requested for our lead anticancer compound ABD-3001 during our first-in-human clinical trial in acute myeloid leukemia upcoming soon. During the set-up of our GMP production, GTP Bioways team has been quite flexible and reactive to our needs “

Ismail Ceylan, Founder and CEO of Advanced Biodesign

Cutting-edge technology for fill & finish

Because of the standards to be achieved for the patient – high quality and 100% safety – aseptic filling is a key step in the manufacturing of therapeutic products.

Our unique state-of-the-art solution for aseptic filling combines a disposable isolator with automation for filling and stoppering. This filling line, composed of 4 sterile ISO5 isolators in an ISO7 environment, ensures the highest quality for your product through limiting human intervention, avoiding cross-contamination and cleaning validation – the most critical parameters during aseptic filling.

GTP Bioways CDMO - Bioconjugates Analytical Development

Discover more about GTP Bioways services

Biologics

Mammalian GMP Manufacturing

Nanodrugs

GMP Manufacturing

Bioconjugates

GMP
Manufacturing

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A Guide to Smooth CDMO Tech Transfer

The key parameters to be considered while choosing your next CDMO, as well as our tips to assess those parameters, and more!