Technology Transfer
We begin by duplicating and validating your process in our facilities, then collaborate with you to set your goals and define:
- Testing method requirements
- Manufacturing process strategy
- Mixing technology
- Raw material supply
- Operating procedures
- Final product labelling and packaging
Clinical Scale
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Scale-up Development
- With the expert knowledge of our production team, we are able to transfer your process and perform scale-up development to your desired volume and capacity. Our services are highly catered to your needs, and we work with you from start to finish throughout the scale-up process.
- Project scope and objectives are to be defined for developmental work and we will provide a process flow, critical operating parameters and operating range for you to use at your facility, or ours.
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Process and Method Validation
- At Esco Aster, we ensure the end-to-end process is accurately tested and verified to the most stringent standards. This is part of our commitment to ensure our process is reliable and ready for clinical supply. Product and process are tested from the raw material stage to final product. We are equipped with analytical tools and testing equipment to ensure highest product quality.
Commercial Supply Scale
Esco Aster specializes in the formulation of complex biological and lipid-based nanoparticles. We can tailor a pharmaceutical manufacturing process to your required specifications as a CDMO, including aseptic product manufacturing and end-point sterile filtration.
We can work with you to accomplish your scaled-up production needs, regardless of where you are in the development process.
Aseptic Fill and Finish
Our facility is fitted with our own filling line isolators that are compliant to international GMP standards. Our system includes:
- Vial washing and depyrogenation tunnel
- Precise check-weighing system
- Stoppering and capping system
- Optional freeze drying
Vial Inspection and Packaging
The primary packaging for pharmaceutical items is where patients' safety begins. It's crucial to have technology that can reliably and cost-effectively monitor the process chain.
We offer best-in-class technologies and expertise at Esco Aster to ensure that each vial is filled to GMP standards, examined, and packaged properly.
Analytical Testing and Quality Control
In order to meet standards, Esco Aster conducts daily quality control checks and compendial testing methods for raw materials and drug products.
