CDMO: Transfer your pharmaceutical processes with confidence

Transferring a manufacturing process to a new production site is a strategic and delicate process.

At Unither, we support this transition with a methodical, rigorous, and responsive approach, for both medicines and medical devices.

Whether it is a product in the development phase or already manufactured on our lines, by a third party, or at your production site, our team ensures robust and documented technology transfer. The transition to production is conducted according to validated procedures, ensuring reproducibility and compliance right up to commercial production.

We specialize in particular in liquid dosage forms, using technologies such as Blow-Fill-Seal, Stick Pack, and sterile multi-dose solutions in vials, with or without preservatives.

production stick-pack

For what types of technology transfer projects?

  • Products in the post-clinical or industrial pharma scale-up phases (biotechs, start-ups)
  • Transfer from another CDMO or an in-house site
  • Outsourcing or relocation of manufacturing
  • Adding a second production site (dual sourcing, back-up)
  • Transferring a product with Marketing Authorization (MA) to a new production site

Expertise in technology transfer and scale-up

Adoption and adaptation of existing processes

From another CDMO, an in-house facility, or a UNITHER site

Definition of critical parameters & transfer plan

Gap analysis, adaptation of equipment and processes

Pilot batches, robustness tests & industrial qualification

Product equivalence, analytical performance, and compliance

Controlled scale-up

From pilot manufacturing to validated scale-up for commercial production

Production capacities

Sterile and non-sterile liquid dosage forms

solutions, suspensions, gels

Key technologies

Blow-Fill-Seal, Stick Pack, preservative-free multi-dose

Multi-certified sites

FDA, EMA, ANVISA, Health Canada, etc.

Flexible volumes

from 0.5 L to several thousand liters

Comprehensive Support

analytical development, qualification, validation, regulatory support

Why choose Unither as your CDMO for your pharma tech transfer?

A proven methodology, from planning to production launch

In-depth expertise in sensitive processes and complex dosage forms

A dedicated project contact specialized in the implemented technology

Ability to optimize pharma scale-up, taking into account your regulatory and commercial objectives

Multi-form and multi-site versatility within an integrated international network

Do you have any questions? - See our FAQ on tech transfer and pharmaceutical scale-up

Pilot manufacturing allows the process to be tested using smaller batches. Commercial production is carried out when the process has been validated and is repeatable and compliant with GMP standards, ready for market launch.

The duration varies depending on the complexity of the process and the documentation required. Typically, a full tech transfer takes between 6 and 18 months.

Outsourcing the manufacturing of a drug or medical device to a CDMO offers increased flexibility, reduced time-to-market, and access to specialized technical and regulatory expertise.

An experienced CDMO also offers certified industrial facilites that are adapted to every phase: scale-up, validation, commercial production, post-MA transfer, etc.

Successful pharmaceutical industrial scale-up requires a competent understanding of critical parameters, equipment, and the validation plan. An experienced CDMO ensures that each stage of the scale-up runs smoothly.