Manufacturing Platform

At SyVento BioTech, we understand the critical importance of the final step in drug product manufacturing. That is why we aim to provide excellent fill and finish services in our soon-to-open, state-of-the-art facility designed to meet cGMP standards and ensure consistent product quality and control.

Process Scaling

We offer the possibility of scaling the production of formulations based on lipid nanocarriers by transferring solutions developed in the laboratory on a semi-technical and technical scale. Thanks to the extensive equipment base, we are able to perform:

Upscaling

starting from very small batches (25µl) and up to 50L batches:

  • Lab Scale
  • Demonstration Scale
  • Pilot Scale
  • Commercial Scale

Vials Filling

Our production line is capable of continuously filling 2000-3000 vials per hour, ensuring efficient and seamless fill and finish operations

Our fill and finish services are highly flexible and can be performed with a ready-to-fill bulk or with compounding based on your specific requests.

We utilize advanced technologies, such as isolators, lyophilizers, and automated filling equipment, to ensure high product quality and safety. Our services include formulation development, analytical services, and manufacturing process development. We provide customizable solutions to meet the specific needs of each Partner while ensuring quality control and regulatory compliance.

At SyVento, we understand the challenges of RNA-LNP drug development, such as drug product quality, drug substance and lipid quality, scalability, time, cost, and infrastructure. That’s why our platform solutions are designed to overcome these challenges and provide comprehensive support throughout all stages of your product development and manufacturing.

Tangential Flow Filtration (TFF)

  • The SyVento BioTech formulation laboratory has been fitted out with a modern tangential flow filtration (TFF) system. The system can operate in diafiltration, suspension/solution concentration and mixed modes.
  • Due to the possibility of using filter cassettes, as well as “Hollow Fiber” column filters of various sizes, capacities and types of membranes, this system is used in the “downstream” processes and purification of both liposomes and LNP lipid nanoparticles, as well as nucleic acids and proteins.
  • The selection of appropriate filter parameters enables the scale up of the filtration process from approx. 30 ml to 10 l.
  • Due to the presence of shear forces and relatively high pressures in the system, it is necessary to optimize the process dedicated to liposomal/LNP formulations.